Express Pharma (Vol.11, No.4) May 16-31, 2016

VOL. 11 NO. 14 PAGES 76

www.expresspharmaonline.com

Market ‘Innovation has been the foundation of growth for our group’

16-31 MAY 2016,` 40

CONTENTS MARKET Vol.11 No.14 MAY 16-31, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Ravindra Pawar - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis

PHARMA Pro&Pack Expo 2016 showcases India's strength in pharma machinery 530 international buyers and 18,600 domestic pharma trade visitors attended the exhibition | P12

COVER STORY

INSIGHT P20: Pharma quality assurance in 21st century: Sharper focus needed on education, training and experience

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DR MUHAMMED MAJEED, FOUNDER AND CHAIRMAN, SAMI/SABINSA GROUP

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INDIAN PHARMA SECTOR EXPORTS CAN GROW MULTIFOLD: COMMERCE SECRETARY

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DELABCON 2016 HELD IN MUMBAI

P LIFE

PHARMA TECHNOLOGY REVIEW GMP SPECIAL

P22: Building quality excellence in pharma industry

P26: Pharma quality and compliance: Has the 'elephant in the boardroom’ been recognised?

RESEARCH

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BACTERIA BLOCKS MOSQUITOES FROM TRANSMITTING ZIKA: BRAZILIAN STUDY

P29: Indian pharma: Bad at GMP

Manager Bhadresh Valia

compliance or victim of unwarranted regulatory expectations?

Scheduling & Coordination Ashish Anchan

P30: Tackling GMP

CIRCULATION Circulation Team Mohan Varadkar

non-compliance: A top priority!

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IPMMA AWARDS PHARMA MACHINERY PLAYERS

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SMRITI COLLEGE OF PHARMACEUTICAL EDUCATION, INDORE ORGANISES SEMINAR ON HERBAL MEDICINES

PHARMA ALLY

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ION EXCHANGE EXPANDS BAHRAIN BUSINESS TO MEET GROWING DEMAND IN GULF MARKET

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Embracing quality as an opportunity

C

oncerned with declining pharma exports in the recent past, the Ministry of Commerce & Industry has tried to burnish the brand image of India's pharmaceutical sector. A key initiative has been to host regulators at iPHEX, an International Exhibition for Pharma and Healthcare. Pharmexcil's efforts at IPHEX and other such international exhibitions finally seem to have borne fruit with a 9.7 per cent jump in exports in 2015-16.

Speaking at the fourth iPHEX, the Union Commerce Secretary, Rita Teaotia commented that the nearly 33 per cent growth in exports to the US market in the last fiscal, despite several domestic companies facing the heat from US FDA last fiscal, showed that the companies are capable of taking on these regulatory challenges.

Her colleague, Sudhanshu Pandey, Joint Secretary, Department of Commerce took the same line when I interviewed him at iPHEX. He said that Indian pharma's regulatory woes have attracted a disproportionate level of negative press even though the ratio of 483s issued to India-based plants is not disproportionate. (See his interview: The companies who export must comply with the regulations of the importing country; pages 18-19) He also makes an interesting argument for allowing countries to choose the methods as per their national health requirements, which might be common among some countries. PIC/S is one convention, we could have another, he suggests. Can a globally connected world have different levels of quality standards for medicines? It’s anyone's guess where this discussion will go.

The Express Pharma May 16-31 issue, is a GMP special issue, with a line up of global experts giving their perceptions on this vexing topic. With global regulators now making it clear that senior managements will be held accountable for lapses in quality, has the 'elephant in the boardroom' been finally acknowledged and addressed?

Yes, adherence to GMP guidelines is the agenda for top managements but senior management is not talking much about it beyond the usual press statements. With good reason, as regulators do not like to be preempted. Industry insiders refer to the case of a big Indian pharma company which faced a backlash when they called a press conference stating that they were confident that a recent plant inspection had satisfied global regulators and the import ban on that facility would soon be lifted. The inspectors were not amused and the company had to sweat it out longer than expected.

But the numbers do support the Joint Secretary's assertion that India gets disproportionate bad press. A McKinsey white

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At least one pharma facility worldwide entered into a consent decree every year since 2008 globally

paper titled 'Quality Excellence: The next frontier for the Indian pharmaceutical industry', released in February this year pointed out that India's share of US FDA inspections of pharma manufacturing sites went up to 11 per cent in 2015 (135 upto September 2015, extrapolated for the whole year), from an average of six per cent (102 inspections in 2011-2014). Yet the proportion of OAI +VAI (Official Action Indicated + Voluntary Action Indicated) decisions remained the same: 65 per cent during 2011-2014, compared to 63 per cent in 2015. (See pages 22-25: Building quality excellence in pharma) So, should we dismiss these quality concerns?

No way. In fact, the Joint Secretary emphasises that the companies who export must comply with the regulations of the importing country. But India is not the only country grappling with quality.

According to the McKinsey report, between 2008 and 2014, the number of product recalls and warning letters (WLs) to pharma companies globally tripled. At least one pharma facility worldwide entered into a consent decree every year since 2008 globally.

Which is why capacity building is crucial and not something that can happen overnight. It will happen one facility, one location at a time.

A former member of the US FDA, Dr Ajaz Hussain, Founder CEO, Insight Advice & Solutions today conducts training programmes for pharma companies. In his article, (pages 20-21: Pharma quality assurance in 21st century: Sharper focus needed on education, training and experience) he advices that leaders of India's pharma sector should set up Global Institutes of Pharmaceutical Quality (GIPQ) which will contribute to the knowledge and expertise needed to improve regulatory science and policy across the globe.

Given the size of the industry, it may take another two-five years before we see a measureable improvement but things have already started moving in the right direction. For example, Indian Pharmaceutical Alliance and McKinsey are in the process of preparing data integrity guidelines, borrowing from various global drug regulatory systems. Nine out of 10 WLs to Indian pharma companies cite data reliability issues so tackling this gap could address a significant chunk of lapses.

IPA and McKinsey is also in the process of conducting a quality culture survey across six major Indian pharma companies to serve as a benchmark for the industry. These are but initial steps, but momemtum will build up once the bigger pharma companies start reaping the benefits of embracing quality as an opportunity rather than a risk.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

Innovation has been the foundation of growth for our group Sami/Sabinsa Group, leading nutraceuticals producer, has launched Curcumin Chewable, an immune-support supplement for children. Dr Muhammed Majeed, Founder and Chairman, gives more details about the product and the company’s nutraceutical business, in an interview with Sachin Jagdale Tell us about your offerings in children nutraceuticals.

Sami Direct’s Curcumin Chewable is an essential immune support supplement with a versatile phytonutrient that supports overall wellness and good health by offering the benefits of quality curcuminoids from nature’s own turmeric roots. It is a safe and effective solution that offers immune protection across all seasons for all ages.

One of nature’s greatest gift to mankind is turmeric. Its active constituents Curcuminoids, have been documented in ancient texts such as Ayurveda where it is considered vital to naturally improve immunity. To its credit are 7500 and more scientific publications that speak volumes of its acceptance and recommendations by the scientific fraternity.

Curcumin Chewable is a preferred solution to enhance the body’s defence mechanism against seasonal changes, environmental factors and lack of nutrition.

With health drinks like Complan, Horlicks etc. already available in the market for many decades

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how are you going to convince the parents to try your product?

The goodness of turmeric is well recognised from the times of Ayurveda, but is not available in a form that is acceptable by children.

Parents are well aware that a little turmeric in their child’s warm milk will offer relief from seasonal allergies.

However, the flavour and aroma is not preferred by children. Curcumin Chewable is a convenient dosage form of the same turmeric with enriched goodness in the form of Curcumin C3 Complex. The 4000 year old legacy of turmeric to suit the current generation and scientifically validated by modern scientific techniques for its safety and efficacy, this product is widely accepted and appreciated by parents.

Besides children nutraceuticals which are the other types of nutraceuticals you manufacture?

Innovation has been the foundation of growth for our group. We have been innovative in our process, product and in its applications. Working with

this mindset, and having been in the industry for over 27 years, the Sami group has a range of nutraceutical and cosmeceutical products for various applications targeting diverse audience.

General wellness, immune support, eye care, energy support, weight management, protein supplements, joint support and vitamin and mineral complexes are just a few to mention. The products have been formulated with the foundations of Ayurveda and other traditional knowledge systems, supported by modern scientific validation.

How are your nutraceuticals different/better than your competitors'?

The Sami Group is a research oriented, multinational health science organisation, and a leading producer of nutraceuticals, cosmeceuticals, standardised herbal extracts, fine chemicals, speciality chemicals and probiotics.

The Government of India has honoured the company with the National Award for quality products (basic drugs) in the year 1994 and

the prestigious DSIR award in the year 2002. Today, it has 113+ international patents to its credit. The group has been a pioneer in innovation of standardised herbal extracts that have found their way into millions of dosage forms. The organisation also believes in being self sustainable and engages in contract manufacturing to ensure best quality raw materials and in turn finest end products.

The concept of nutraceuticals is still not that popular in the Indian market, how difficult is it to generate business in this scenario?

The concept of nutraceuticals is new and hence business is a challenge in India. However, Ayurveda and the knowledge of herbs is something that this country is very familiar with. It is well accepted among consumers. The modern scientific techniques that have been used to validate this knowledge is the only missing link that needs to reach the consumers. A constant effort is made by the company to educate consumers in this regard through articles, books, websites and so on. While the

task is uphill, it shows a very positive and encouraging trend.

Nutraceuticals are generally considered expensive. As India is a cost sensitive market how do you plan to handle this issue?

One of the major challenges of the organisation has been to provide quality products that are affordable to the common man. Products from Sami are of the best quality in prices that are affordable.

Since the company directly handles every stage – farming, extraction, research, formulation development, clinical validation, production and marketing – all under one big roof, the products are made available at very affordable prices.

Any new product in the pipeline?

The Sami group is under constant innovation. A range of products have been lined up for the year both in the nutraceutical as well cosmeceutical category that will satisfy the needs of consumers. sachin.jagdale@expressindia.com

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MARKET POST EVENT

Indian pharma sector exports can grow multifold: Commerce Secretary Regulatory norms and growth potential for Indian pharma took centrestage at iPHEX 2016 EXPRESSING satisfaction on the performance pf the exports in the last fiscal, Rita Teotia, Commerce Secretary, Ministry of Commerce, emphasised that the Indian pharma sector is strong and has the ability to grow to a much larger global market share. “The Indian pharma industry is best placed to take this leap as India offers several advantages such as skilled manpower, large pool of scientists, favourable policy framework and global experience of the industry,” she said, speaking on the sidelines of the fourth edition of iPHEX 2016 in Mumbai.

The Commerce Secretary’s thoughts resonated at the second day of the mega event. The international pharmaceutical and health expo’s second day proceedings touched upon various facets of the pharma sector, such as, pharmacopoeia standards and resolving regulatory challenges to facilitate manufacturing and exports from India. Overseas representatives from Ghana, Japan and Nigeria actively participated in panel discussions with Indian FDA officials and pharma regulators.

An initiative by the Ministry of Commerce, Govt of India, the three-day iPHEX 2016 was organised by Pharmaceuticals Export Promotion Council of India (Pharmexcil) under the Brand India Pharma Campaign. It is one of the few platforms which integrate pharma and healthcare sectors at one venue to showcase Indian products and technologies to a global audience. This year's event attracted over 40 drug regulators from various countries, more than 300 Indian exhibitors, and 600 overseas business visitors from over 100 countries.

Concurrent events such as

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buyer-seller meets reinforced delegate-enthusiasm and the trust in Indian pharma sector.

These buyer-seller meets managed to generate 3000 potential enquiries on day two.

Dr PV Appaji, Director General, Pharmexcil noted that this participation was one-of-a kind, and delegate invitations sent to over 100 countries have led to potential increase in exports. “Serious enquiries have been gathered in varied pharma fields such as APIs, nutraceuticals, ayurvedic, dosages, drug formulations, etc in the area of generic drugs as well as R&D and patents. Quality and reliable safe drugs to end-users is a critical challenge in the global supply chain, which most governments and regulators are attempting to bridge. The seminars discussed these challenges. Pharmexcil and the iPHEX platform is focused on resolving and providing a sound platform to deliberate and iron out such challenges.”

The Indian pharma exports stand at $17 billion currently and grew by 9.4 per cent in 2015-16. The Indian market, exports $12.7 billion worth pharma goods in generic category, which is 5.8 per cent of the overall global generic market. Sudhanshu Pandey, Joint Secretary, Ministry of Commerce, averred that the Indian pharma sector not only offers cost benefits but also quality in products. He said that we should not focus on the pharma sector alone, but on the entire ecosystem. Associations and universities can contribute through student-exchange and by conducting various symposiums to discuss and deliberate on crucial issues, thereby leading to quality and affordable pharma products.

MARKET

PHARMAPro&Pack Expo 2016 showcases India's strength in pharma machinery 530 international buyers and 18,600 domestic pharma trade visitors attended the exhibition THE 4th PHARMA Pro&Pack Expo 2016, an international exhibition on pharma manufacturing technologies and concurrent exhibition, PharmaLAB Expo 2016 were recently held from April 27- 29, 2016 in Mumbai. Jointly organised by the Indian Pharma Machinery Manufacturers’ Association (IPMMA) and GPE EXPO (GPE), the event aimed to provide business opportunities to exhibitors from the domestic as well as international markets.

The event was co-located with iPHEX 2016 (organised by Pharmexcil). Rita Teotia, Commerce Secretary, Department of Commerce, Ministry of Commerce & Industry, Government of India formally declared the exhibition open and visited the PHARMA Pro&Pack Expo 2016 and PharmaLAB Expo 2016 exhibitions. She interacted with the exhibitors to get live feedback from the industry.

The exhibition displayed the complete spectrum of pharma machinery and allied services including analytical and biotech lab equipment. The exhibition has emerged as the largest trade platform with participation from all major pharma machinery and engineering technologies’ manufacturers.

The reverse buyer – seller meet, organised in association with EEPC INDIA (Ministry of Commerce & Industry, Govt of India), provided an opportunity for all buyers to identify, select and finalise their machinery and engineering requirements from a single exhibition.

Over 530 international buyers and 18,600 domestic pharma trade visitors attended PHARMA Pro&Pack Expo 2016, PharmaLAB Expo 2016 and iPHEX 2016 exhibitions.

Business (domestic and exports) worth over `1,200 crores for the pharma machinery and engineering segment was

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MARKET generated from the three-day PHARMA Pro&Pack Expo 2016 exhibition.

PHARMA Pro&Pack Expo 2016 and PharmaLAB Expo 2016 were supported by all major pharma trade associations including Authentication Solution Providers' Association (ASPA), Association of Pharmaceutical Producers of Nepal (APPON), Bangladesh Association of Pharmaceutical Industries, Indian Drug Manufacturers' Association (IDMA), EEPC India, Federation of East African Pharmaceutical Manufacturers (FEAPM), Indian Pharmaceutical Association (IPA), Scientific Apparatus Manufacturers & Exporters, Confederation of Indian Pharmaceutical Industry (CIPI), Indian Pharmacy Graduates Association (IPGA), American Association of Indian Pharmaceutical Scientists (AAiPS), Pharmaceutical Manufacturers

The exhibition has emerged as the largest trade platform with participation from all major pharma machinery and engineering technologies’ manufacturers Group of the Manufacturers Association of Nigeria (PMGMAN).

During the event, IPMMA and GPE also felicitated seven pharma machinery manufacturers who have completed over 50 years in the pharma industry.

They were Gansons, IMA PG, Pharmalab India, SB Panchal & Co, Standard Engineers, Tapasya Engineering Works, and The Bombay Engineering Works. (For more details, see pages 70-71)

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MARKET

DELabCon 2016 held in Mumbai It served as a platform to bring designers, engineers, scientists, consultants to discuss on the evolving sphere of laboratory design and engineering SCIENCEBYDESIGN, a laboratory engineering firm, recently hosted DELabCon 2016, a one-day conference on design and engineering. It was held at Courtyard Marriott, Andheri, Mumbai. The conference was inaugurated by Dr KP Kaliappan, Head of Chemistry Department and former Associate Dean (R&D), IIT Bombay.

The conference comprised sessions and a panel discussion on varied topics from the domain; conducted by eminent guest speakers of national and international repute. The topics discussed at the event centered on safety, design, architecture and sustainability of laboratories in pharma and chemical industries, and their evolution and future trends. Topics were chosen to address the industry’s needs.

The speakers at the conference included Kumar Ravindra and Naresh Narsimhan from Venkatramanan Associates, Nitin Deodhar from Vision Electro Mechanical Consultants, Archana Salil from Arena Consultants, Ravindra Kelkar from Tata Chemicals, Chip Diefendorf from Mott Manufacturing, Canada. The panel discussion was moderated by Lipika Nair from TexAssist Consultants. The panellists were Archana Danait from Clariant India, Amar Hegde from Kottermann GmBH Co KG, Srinivas Kumar Kondapaneni from Laurus Labs, Kapil Bhargava from ISPE, Kumar Ravindra from Venkatramanan Associates and Hitesh Lachchwani from Castrol India.

Salil Sansare, Founder Director, SciencebyDesign said, “I am excited to say that the conference met with huge success as most of the industry stakeholders with deep domain knowledge and breadth of experience participated in it, thus making it an inclusive

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Dr Kaliappan, Associate Dean (R&D), IIT Bombay (standing extreme left) published the souvenir. (From L to R) Kumar Ravindra, Director - Design & Naresh Narasimhan, Architect & Managing partner, Venkataramanan Associates, Bangalore; Nitin Deodhar, Vision Electro Mechanical Consultants, Pune; Ravindra Kelkar, Tata Chemicals, Pune; Chip Diefendorf, Mott Mfg - Canada; Archana Salil, Arena Consultants, Mumbai

Topics at the conference were on safety, design, architecture and sustainability of labs in pharma and chemical industries experience for over 50 delegates. Participants came across from places like Canada, France, Bangalore, Baroda, Delhi, Vizag, Pune and of course Mumbai.”

DELabCon 2017 will be held at Bengaluru and the date will be announced soon.

Salil Sansare, Founder, Science by Design & Chairperson, DELabCon 2016 felicitating Dr KP Kaliappan, Associate Dean (R & D), IIT Bombay. Dr Kaliappan inaugurated DELabCon 2016

EVENT BRIEF AUGUST 2016 5

PharmaLytica 2016

PHARMALYTICA 2016 Date: August 5-6, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: The third edition of PharmaLytica 2016 will see the pharma community pick up on the latest industry trends, innovations and do business with analytical, bio tech, lab, pharma machinery and outsourcing services.

PharmaLytica conference, co-located with the exhibition will bring an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector.

The event is likely to witness 150+ leading local, regional, and international exhibitors, with 4500 expected visitors. It will be an industry focused conference with latest pharma market insights, in-depth case studies, and exceptional networking oppor-

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PharmaTech Expo 2016

tunities. Both the events are supported by Ministry of Science & Technology, Govt of India Contact UBM India Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel: +91 22 61727272 Fax +91 22 61727273

PHARMATECH EXPO 2016 Date: August 21-23, 2016 VENUE: Ahmedabad Summary: The 4th Edition of 'PharmaTech Expo 2016, a PharmaTechnologyIndex.com venture will organise a pharma expo. The expo will be concurrently held with 'Pack & PrinTech Expo' and introduction of 'PIC India Expo.' It will focus on pharma ingredients and

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2nd Edition of Asia Labex

chemicals, giving a large scale exposure to pharma machinery, pharma ingredients and chemicals, packaging, printing, lab and analytical equipment etc.

More than 150 exhibitors are likely to participate in the event.

A special pavilion has been created for 'Track & Trace and Vision Inspection Equipment' to focus on the superior technologies available in India and the major industry players involved.

Contact Aarjav Shah PharmaTechnologyIndex.com (A Division of KNS Group) Tel: +91 – 79 – 27540493 / +91 – 79 – 40306340, 9879616665 E-mail: expo@pharmatechnologyinde x.com / events@knsmedia.com Website:

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www.PharmaTechExpo.com / www.PackPrinTechExpo.com / www.SwarnimVision.com

2ND EDITION OF ASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotech, research and testing instruments and consumables. The exhibition will be organised by Fenza Exhibitons.

Contact Fenza Exhibitions Plot No 1, 2nd Floor, GT Karnal Road, Opposite PNB Bank, New Delhi – 110033

analytica Anacon India and IndiaLabExpo 2016 ANALYTICA ANACON INDIA AND INDIALAB EXPO 2016 Date: October 20-22, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: analytica Anacon India and India Lab Expo happens to be India's largest trade fair for the analysis, laboratory-technology and biotechnology sectors. As the industry's leading marketplace, it brings together scientists, entrepreneurs and users from around the subcontinent.

At the analytica Anacon India and India Lab Expo Conference, scientists from around the world will present their innovative analysis solutions.

Contact Email: info@analyticaindia.com

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cover ) I N T E R V I E W

‘The companies who export must comply with the regulations of the importing country’ Sudhanshu Pandey, Joint Secretary, Department of Commerce, Ministry of Commerce & Industry, Government of India takes some tough questions from Viveka Roychowdhury on the sidelines of the recently held iPHEX 2016. Now in its fourth edition, the trade show, conceived by his Ministry and Pharmexcil, as a platform to burnish India Pharma Inc's global image, saw regulators from countries as diverse as Ghana, Nigeria and Ukraine, to name just three countries, hold discussions and decide to work towards harmonisation of regulations.

Edited excerpts from the interaction

Sir, there is no escaping the fact that the slew of 483s, warning letters, and batch recalls against pharmaceutical manufacturing plants in India over the past few years have damaged Brand India Pharma. What is your ministry's strategy to address this perception?

Firstly, if you undertake a comparative analysis of 483s issued on a global basis, the ratio of 483s issued to Indiabased plants is not disproportionate. Secondly, the quality or safety of the end product has not been the issue at all in any of the cases. The inspection procedure has become too process driven.

For instance, if an inspector notices scope for improvement in a particular process, it does not necessarily mean that the process is wrong, his interpretation is that since there is a gap, there is a possibility of manipulation, so it deserves a 483. But, the same inspector could have advised the company to further improve the process.

We are engaging with overseas regulators on these aspects but I want to reiterate that the companies who export must comply with the regulations of the importing country and I believe 100 per cent in this.

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What can industry and the Indian regulatory system do to plug these gaps?

One major gap during the inspection process is that staff at the middle and lower levels may not speak fluent English or understand the accent.

Inspectors coming from nonEnglish speaking countries might not speak fluent English as well.

Many inspectors have started speaking to the shop floor level staff during the inspection, instead of talking to the management. These staff get nervous and scared during these interactions, because in the Indian culture, an inspection has a negative connotation and is considered an examination or a punishment instead of being seen as a normal part of the production process.

So, the plant worker has trouble understanding the query of the overseas inspector, and mumbles a reply, then contradicts his own statement because of lack of clarity caused by the language barrier. The inspector will issue a 483 simply because there is a mismatch between the statements of the senior management and staff, even though there may be no evidence that the process was indeed compromised. Is this an evidence-based approach?

I believe a simple solution to the language barrier is to have inspectors take translators with them as is being done by them in China.

In fact, this is one of the suggestions we have presented to overseas regulators. These discussions do seem to be bearing fruit.

One overseas regulatory body has reportedly started a weeklong orientation programme for inspectors before they depart for India, so that they can correctly interpret some of the cultural responses. We are stressing that the inspector's evaluation should be totally evidence-based.

Our pharma companies have started investing in training and capacity building of their own employees at all levels

Do you see any improvement in the situation?

Yes. Indian pharma's regulatory woes have attracted a disproportionate level of negative press. But the positive side is that our pharma companies have started investing in training and capacity building of their own employees at all levels, which is the long term answer.

The government is also investing in human resources.

The Ministry of Health & Family Welfare is recruiting more inspectors to build muscle. Both my department, the Commerce Ministry, and the Health Ministry, are interfacing more regularly

with the state governments to convince them to invest more in the drug regulatory system within states. The number of federal drug inspectors has already increased from 30 to 183, and this number will further increase. I estimate that the combined regulatory staff, at federal and state levels, including inspectors, would be around 1500 today.

This number is far from sufficient, considering that India has almost 10,000 pharma manufacturing facilities. Contrast this with the fact that the US has 15000 regulatory staff for 3000 pharma manufacturing facilities. We do have a long way to go.

But can a country like India afford it? Either the tax payer, the industry or the end consumer would have to pay.

The US chose to increase inspection fees [via the Prescription Drug User Fee Act (PDUFA)] which has been in place for over two decades and the more recent Generic Drug User Fee Amendments of 2012 (GDUFA)) and the result is that patients in the US have had to pay more for medicines.

Ultimately, the bottom line is, can you give the developing world, the quality desired by the developed world, at developing world prices?

( Quality does come at a cost.

The question is, who will bear this cost? This is the challenge.

Therefore, I believe that we have to strike our own balance, deciding the optimum level of quality so that human health is not compromised. As long as there is enough oversight, sincerity and commitment during the manufacturing process, chasing the state of 'zero possibility of error' would be a questionable investment.

This is the point I made at a session I chaired at IPHEX, which had regulators from Ghana on the dais as well.

Firstly, developing countries would have to find their own optimal levels of quality.

Secondly, there has to be a system of harmonisation because if the same process is repeated in multiple countries, the cost will go up. If there is mutual trust in each others' quality system, then there is no need to replicate the process. Today, even if you are a member of one of the PIC/S countries where you have invested a lot in all the three stakeholders (regulator, government and industry) there is still no guarantee that your dossier will be accepted in another PIC/S country as they may decide to apply their own national laws. (PIC/S refers to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, a movement started in October 1970 by the European Free Trade Association (EFTA) to harmonise GMP regulations) Developing countries need to come to this mutual understanding because they have no choice but to consider healthcare as a national priority. Else the demographic dividend will not be an asset but a liability, a demographic disaster. It will not happen overnight but this narrative has to start.

So, what is the solution? Do you envisage different groupings of nations, along

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the lines of the G8-G20 situation?

I would not advocate a G8-G20 divide, but rather allow countries to choose the methods as per their national

health requirements, which might be common among some countries. PIC/S is one convention, we could have another. If we can achieve the same quality with different

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processes and methods, thus reducing costs, why not? Of course, vaccines and complex molecules for cancer, etc. do need to follow set processes and methods as they need

higher quality standards. But we can follow this for simple, easy-to-handle molecules, where the risks are minimal. viveka.r@expressindia.com

cover ) INSIGHT

Pharma quality assurance in st 21 century: Sharper focus needed on education,training and experience

AJAZ S HUSSAIN Founder CEO Insight Advice & Solutions, & President, NIPTE, US

Ajaz S Hussain, Founder CEO, Insight Advice & Solutions, and President,The National Institute for Pharmaceutical Technology & Education (NIPTE), US, opines that there is a need to develop curricula and approaches to develop talent in terms of technical know-how, communication skills and maturity to assure pharma quality and ensure cGMP compliance

I

ndia’s aspiration to be the ‘Pharmacy of the World’ is credible, palpable and indispensable. Progress achieved over the past several decades is remarkable. A key determinant of this success is the talent pool in India; which is relatively young and getting younger. The quality of their education, training and experience is an important determinant of the level of assurance in pharma quality that they can and will deliver.

In the current state, inspectional observations particularly by several global regulatory authorities have given a reason for a ‘pause’ - to reflect on how global regulatory expectations for the assurance of pharma quality should be met. Although this challenge is not unique to India; it points to certain ‘blind-spots’ in the current system. Attention to these gaps are in need for urgent attention.

Many products we develop and manufacture today are complex; and complexity is on a rapid rise. This places a higher demand on scientific evidence necessary to assure quality, safety and efficacy (and equivalence) over the lifecycle of these products. Assurance of data integrity is a critical basis for assuring pharma quality.

There is a need to bring more

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Insight 2013 8

Where are we in 2016?

Perceptions about quality can change efficacy and safety of a drug product via placebo and nocebo effects

Evidence on the significance of perception factors, and placebo/nocebo effects, emerged very prominently, particularly in the US, and the US FDA had to issue a final guidance highlighting the importance of colour and shape of tablets have on adherence rates 9,10.

Remediation of cGMP issues is often difficult and is an expensive challenge

CGMP remediation, particularly as it relates to US FDA Warning Letter and Import Alerts, are on-going with very few exceptions and other companies have been added to this list.

Leaders should consider working together in pre-competitive space to strengthen training and education, and, for creating venues for dialogue with regulators to improve understanding and to seek out solutions to common challenges.

Leaders of India’s pharma sector have taken significant steps to collaborate and to engage with global regulators and are outlining a plan- “Quality Excellence”11.

With the active encouragement of the US FDA, there is visible progress in the area of continuous monitoring and manufacturing of pharma APIs and products in an integrated manner – a potential shift in paradigm in the making.

Automated continuous manufacturing is now rapidly becoming a reality in the US and Europe, tipping point was reached in 2015. Significant collaborations have been announced among major companies12.

Increasingly patients across the globe will ask the question “who makes the drug I take”; and trust and credibility will be critical.

Media coverage of FDAWarning Letters and Import Alerts have continued to be a source of concern 13.

attention, and give more importance, to integrity of evidence. Noted CGMP deviations are, perhaps, a ‘blessing in disguise’; learning from these examples, India’s pharma sector can accelerate its progress towards achieving its goals with better accounting of complexity and uncertainty in

their systems.

Unless proactive steps are taken, ‘blind-spots’ such as the following can emerge in any rapidly growing business: (a) human tendency for optimistic business forecasts and expectations (e.g., rate of ‘right first time’), (b) under-appreciating

intrinsic error rates in the system and (c) not recognising an increasing complexity in pharma quality assurance. Such cognitive biases can put a high burden on achieving rational assure of quality; especially when results, and the not the process for getting to the

result, is the primary incentive.

In such situations, staff and managers can be in over our heads1 and vulnerable to irrational decision making2. Other cognitive biases or blind-spots such ‘it is US FDA approved’, and ‘process is validated’ can sometimes provide reasons for rationalising deviations from established and committed (to regulatory authorities) procedures. Gaps that may have existed in an ‘FDA approved’ submission, for example; attitudes such as “file first and figure it out later”3 can leave gaps in development of a commercial manufacturing process which should be stable and in control. After FDA approval, such gaps are not easy to remember4-7. Again, this scenario can manifest anywhere in the world.

Response to the “pause”, induced by the numerous warning letters and import alerts, has varied. Some have questioned this pause. Others have focused on understanding what needs to be understood more clearly and/or more consistently. This paper seeks to support the latter by sharing some insights on how to strengthen education, training and experience4-7. This paper is organised to consolidate these insights in the current context:

( a) Recapitulating insights shared previously, 2013 “Strategies for making high pharma quality affordable”8; b) Summarise new insights gathered while conducting a training programme entitled “Culture of Pharmaceutical Quality” at many companies located in diverse geographies of India 5-7; and, c) Consolidate these in a global context utilising experience gained as a teacher, a regulator (at US FDA)4, and a corporate executive.

Recapitulating previous insights The table lists insights shared in 2013 and provides an update where are we in 2016. Among these, the growing evidence on the significance of perception factors, and placebo/nocebo effects, particularly in the US, is remarkable. It makes the case for corporate-name recognition stronger even for companies making generic products.

In the US, the year 2015 marks a ‘tipping point’ for continuous manufacturing12.

As discussed in 2013, this potentially sets up a different strategies and path to the coveted title of ‘Pharmacy of the World’8. India’s pharma will need to factor these technological developments into their strategies. Companies with high interest in serving the markets in the US will also need to consider changes outlined in the FDA’s review and inspections approaches; particularly on FDA’s sharper focus on ‘One Quality Voice’ 14.

The efforts proposed by leaders of India’s pharma sector to collaborate, to engage with global regulators, and in committing to ‘quality excellence’11 are commendable.

Some of the insights shared here are intended to encourage and contribute to such efforts.

Insights gathered since 2013 Efforts expended to develop and conduct a training programme on ‘Culture of Pharmaceutical Quality’, for several companies with facilities dis-

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In the long-term, to be a global pharma leader, focus should be on developing institutions that are recognised as important contributors of knowledge and expertise needed to improve regulatory science and policy across the globe tributed across India5-7, provided valuable insights. The key take-away from this effort is that “confidence (of/in people, in process/system/results, and in the assurance of product quality) is a critical quality attribute”. Understanding the ‘Why’, ‘What’ and ‘How’ of this critical quality attribute is highly variable and this variability needs to be reduced, significantly.

Education, training and experience in the 21st century must develop curricula and approaches to develop talent in terms of technical know-how, communication skills and maturity to adapt with confidence to environments where complexity and uncertainty is high and increasing. As noted in 2005, in the US context4, industrial pharmacy education was and continues to be in need, for a transformation. For example, material science, process design and control, more rigorous mathematical and statistical skill sets, and systems engineering are some of the areas that are in need for additional emphasis. More importantly, attention to developing adaptive-learning skills – to increase orders of consciousness1, design/system thinking, and leadership development must be a key areas of focus7.

As leaders of India’s pharma sector progress in their efforts on ‘quality excellence’11, it would be useful to consider establishing world class Global Institutes of Pharmaceutical Quality (GIPQ). Given the aspirations of this sector – it is important to take a global perspective with short-, mid-, and long-term goals. In the shortterm, the focus should be on

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developing adaptive-learning skills, design/system thinking, improving investigations, rigorous risk assessment, seamless continued process verification and other topics relevant to proactive compliance with cGMP. Mid-term focus could be on improving (e.g., standardisation and reducing variability in) the broader educational system and providing more opportunities for effective training and experience in quality by design, process analytical technology, and control strategies.

In the long-term, to be a global leader, focus should be on developing institutions that are recognised as important contributors of knowledge and expertise needed to improve regulatory science and policy across the globe.

Increasing complexity and uncertainty places a high demand on knowledge management and correct analysis of prior knowledge. There are significant gaps (e.g., objective quality risk assessment, establishing clinical relevance of quality specifications and pharma material science as it pertains to functionality and process-ability) and pharma science and technology, as a discipline, has much work to do to fill these gaps. The next decade places a high demand for improving pharma ontology and epistemology such that the benefits of quality by design methodology, which is now an important foundation of the global regulatory system, are fully realised15.

Patients and their care givers need to have trust our systems. India’s pharma is already a major global player.

It can and must nurture institutions such as the proposed

GIPQ to develop knowledge and expertise needed to support the sector and also to inform on ways to improve domestic and global regulatory policies to best meet the needs of patients. The pharma sector is a major part of India’s economy. India already is and will continue to progress as one of the major economies of the world. Let this journey accelerate 16.

References 1. Kegan, R. In over our heads: The mental demands of modern life.” Harvard University Press, 1995.

2. Kahneman D. Thinking, fast and slow. Macmillan; 2011.

3. Ted Fuhr and Katy George (McKinsey & Co). Moving Beyond the Business Case for QbD. 13 March 2011. http://www.pharmaqbd.com/mc kinsey_beyond_business_case_q bd/ (accessed 28 March 2016) 4. Ajaz S. Hussain. The Nation Needs a Comprehensive Pharmaceutical Engineering Education and Research System. Pharmaceutical Technology, September 2005.

5. Ajaz S. Hussain. Culture of Pharmaceutical Quality: Connecting the Dots. Biopharma Asia, September/October 2015.

6. Ajaz S. Hussain. Culture of Pharmaceutical Quality: Quality Management System. Biopharma Asia, November/December 2015.

7. Ajaz S. Hussain. Culture of Pharmaceutical Quality: Personnel Development. Biopharma Asia, March/April 2016.

8. Ajaz S. Hussain. Strategies for making high pharma quality affordable. Express Pharma. 2 November 2013. http://archivepharma.financialexpress.com/sections/

management/2907-strategiesfor-making-high-pharma-quality-affordable (accessed 28 March 2016). Peter A. LeWitt, P A., and Kim, S. The pharmacodynamics of placebo: Expectation effects of price as a proxy for efficacy Neurology, ;84:766–767 (2015) 9. US FDA Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. June 2015.

10. Indian Pharmaceutical Alliance. Quality Excellence: The next frontier for the Indian pharmaceutical industry (2016) http://ipa-india.org/pdf/ipa-report-quality-excellence-2016.pdf (Accessed 28 March 2016).

11. Eric Palmer. Vertex, J&J, GSK, Novartis all working on continuous manufacturing facilities. FDA supports the move as a way to improve quality in manufacturing. Fierce Pharma Manufacturing. February 2015. http://www.fiercepharmamanufacturing.com/story/vertex-jjgsk-novartis-all-working-continuous-manufacturing-facilitie s/2015-02-09 . (accessed 28 March 2016).

12. Caroline Chen and Anna Edney. Generic Drugs: As Imports Rise, Regulators Struggle.

Bloomberg, Mar 18, 2016. http://www.bloombergview.com /quicktake/generic-drugs . (accessed 28 March 2016).

13. FDA Pharmaceutical Quality Oversight: One Quality Voice. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM4426 66.pdf (accessed 28 March 2016).

14. Visioning the Next Decade: NIPTE-FDA Collaboration.

NIPTE Seminar at US FDA, 16 March 2016. http://www.slideshare.net/a2zp harmsci/visioning-the-nextdecade-niptefda-collaboration (accessed 28 March 2016).

15. Ajaz S. Hussain. A 21st Century Fable about Pharmaceutical Quality and Preventing a Clash of Cultures. LinkedIn Post. Sep 13, 2015. https://www.linkedin.com/pulse /21st-century-fable-pharmaceutical-quality-preventing-hussain-ph-d- (accessed 28 March 2016).

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cover ) INSIGHT

Building quality excellence in pharma industry With the pharma industry expanding scale and complexity, quality has emerged as a major focus area. Is quality merely a risk to be mitigated or does it represent an opportunity to create real value and what does it take to build great quality?

Vikas Bhadoria, Director, McKinsey & Company and Leader, Pharmaceutical and Medical Products Practice, India and Jaidev Rajpal, Principal, McKinsey & Company address some of these questions in this article

VIKAS BHADORIA Director, McKinsey & Company and Leader, Pharmaceutical and Medical Products Practice, India

JAIDEV RAJPAL Principal, McKinsey & Company

I

ndia has emerged as one of the major suppliers of affordable, life-saving drugs and vaccines to the world on the back of its distinctive capabilities in product development, manufacturing and process innovation.

India accounts for 60 per cent of global vaccine production, contributing 40 to 70 per cent of the WHO demand for DPT and BCG vaccines and 90 per cent of the WHO demand for the measles vaccine1. Indian generic drugs help reduce healthcare costs worldwide. Medicines of Indian origin account for nearly 25 per cent of the medicines used in the UK 2 , save on the US healthcare costs and give people in Africa access to life-saving drugs.

With more than 33 per cent of Abbreviated New Drug Application (ANDA) filings in 2015 and more than 40 per cent of Drug Master Files (DMFs) in 2014 3 , the Indian pharma industry is poised to continue its remarkable contribution to public health across developed and developing countries.

The question of quality: Risk or opportunity?

Between 2008 and 2014, the number of product recalls and warning letters to pharma

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companies globally tripled. The number of warning letters from the US Food and Drug Administration (US FDA) to Indian manufacturing sites increased from an average of five between 2011 and 2014, to

12 in 20154.

The industry therefore faces the dual challenge of upgrading quality while continuing to deliver life-saving medicines worldwide. The way companies approach the

subject of quality determines whether it is a big risk or an opportunity.

Companies are discovering that quality problems can prove surprisingly expensive.

Recent benchmarking sug-

gests that companies suffering from quality challenges can lose annual revenue up to four to five per cent of cost of goods sold (COGS) 5 and market value of five to 20 per cent6.

(

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Weak quality systems put companies at significant risk of value erosion while quality excellence can be a significant driver of value creation More importantly, the way companies approach remediation can play a significant part in determining the final cost of quality. To address these issues promptly and thoroughly, with a carefully crafted engagement strategy and full organisation commitment is critical for success.

The good news is that quality also has an upside. When an abrasives manufacturing company mired in customer complaints with dwindling sales committed to a 'quality revolution', Defects in Parts Per Million (DPPM) fell by more than a quarter, and sales more than doubled. Another major biopharma company saved over $350 million through sixsigma quality excellence initiatives.

This upside, however, is possible only when you reach an outstanding level of quality. A survey by an auto original equipment manufacturer (OEM) showed that customer satisfaction and loyalty jumped five-fold7 when quality perception moved from 'good' to 'outstanding'. Data from the proprietary McKinsey’s pharma operations benchmarking (POBOS) database shows that companies with a top-quartile quality performance had an average yield loss four times lower than the median.

Maintaining high quality standards thus represents, an opportunity for pharma companies to distinguish themselves in the market, and equally importantly, in the eyes of other industry stakeholders, who are moving towards recognising and actively encouraging quality excellence.

At the Quality Conference organised by the Indian Pharmaceutical Alliance (IPA) where McKinsey was a knowledge partner recently, attendees unanimously recognised the industry’s need to move towards 6 sigma quality. Regulatory initiatives such as risk-based inspections further strengthen the case for investing in outstanding quality systems.

The writing on the wall is clear: Weak quality systems put companies at significant risk of value erosion while quality excellence can be a

significant driver of value creation.

Building outstanding quality Outstanding quality is built (and can be destroyed) at the foundation itself, where it needs to be embedded into three fundamental systems: operating, people and management systems.

■ Quality in the operating system: Product development and operations Organisations generally concentrate on the value stream (suppliers, facilities and market) to deliver quality.

While advances in machines and improved input material quality do merit attention, organisations could benefit from additional focus on the following crucial areas: ◗ Evaluating and upgrading Quality Management Systems (QMS) The rapid growth of the Indian pharma industry has made operations significantly larger and more distributed across geographies, product portfolios much more complex and supply chains denser, with the industry now involving more stakeholders.

So, how can companies evolve and upgrade their QMS to address increasing scale and complexity?

How can they ensure that their systems build in the latest regulatory guidelines and evolving current good manufacturing practices (cGMP)?

Every company needs a customised approach, informed by its overall quality aspiration and legacy systems. McKinsey has found four things to be critical and relevant across organisations: a structured diagnosis to pin-point gaps, a riskbased prioritisation of initiatives to address these gaps, a detailed change management approach (including a plan to transition to a new QMS), and a strong continuous improvement engine. ◗ Embedding quality into the product lifecycle Pharma manufacturers and regulators recognise that today’s 3-

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cover ) sigma level of process and product robustness need to be improved. This is necessary to minimise compliance risks, supply disruptions, unnecessary costs and wasted efforts on the shop floor.

So how can companies successfully build quality into products and processes?

One potential approach could be to adopt a product lifecycle approach to quality.

This means building quality into key processes across the product lifecycle—Quality by Design (QbD) during development, process qualification and technology transfer and continuous process verification during commercial production.

As pharma companies incorporate these elements into their QMS, a few things are critical: robust cross-functional processes at the interfaces, clear handover points, strong governance including reliable robustness scores, knowledge management and an emphasis on capabilities and organisation. ◗ Recognising that high quality does not equal high cost It is a myth that a winning combination of outstanding quality, strong cost-competitiveness and rapid delivery is unachievable. In fact, the best quality plants have the lowest costs and the highest productivity. McKinsey’s POBOS found that higher quality performance went hand in hand with lower unit costs and greater output.

This is not surprising. Quality is an integral part of operations and vice versa. A common set of capabilities and practices, as well as a common culture, form the basis for mature operations and high quality. In fact, in the semiconductor industry, advanced techniques such as design for manufacturability are deployed to improve yield— a measure of quality and productivity. For example; a major semiconductor chip manufacturer was able to improve quality by 40 per cent by reducing line scrap and increasing yield.

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(

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Quality in the management system: The power of predictive metrics

ured by fewer rejections or higher lot-acceptance rates.

Businesses believe, “If you can’t measure it, you can’t manage it.” Designing an effective metrics and governance system that identifies, measures and resolves potential quality risks is an important element of building a quality focus into the management system.

Doing this well can be challenging, especially with the prevalence of outcome-oriented metrics such as recalls or customer complaints, which tell the story after the fact.

Our McKinsey POBOS research points to the power of predictive metrics, which can anticipate quality outcomes and enable preventive actions for better quality assurance.

Another issue is watermelon metrics—green on the outside but red on the inside. In our experience, other elements are critical for an effective governance process: ◗Consistent use of the same core metrics, applying uniform definitions and measurement at the right frequency. ◗A system of cascaded governance forums, which connect top management to the shop-floor and the individual KPIs to business objectives. ◗A meeting environment that supports openness and encourages active problem-solving on quality issues.

The role of leadership in building quality excellence

People systems: Embedding a culture of quality The understanding of a 'culture of quality' varies across leaders and organisations. Some wonder if culture even matters. Others intuitively believe that it does, but are unable to provide hard empirical evidence. Arguments abound over the very meaning of a culture of quality. How can it be defined or measured? Many companies and leaders believe that measuring quality is an elusive goal.

Our research shows that a quality culture drives up to 30 per cent of the outcome8.

Entrenching a culture of quality in the organisation is critical to the pursuit of excellence. This research is based on the link established between quality culture, as measured by an empirically tested survey on quality conducted at the employee level (including focus-group discussions, Gemba walks, analytics that connect the dots across various metrics) and quality outcomes, as meas-

How can leaders shape this journey?

Those who choose to see risk as an opportunity need to establish an aspiration for outstanding quality— setting goals and continuously revising this target beyond visible frontiers. This aspiration sets the course for the organisation. The leaders, as captains of the enterprise, steer their people towards this specific vision.

Leaders can role-model desired behaviours and actions—asking themselves and their top management team candid questions about quality, demonstrating openness and a knack for root-cause problem solving.

In a quality crisis, many organisations focus on the negatives or what not to do, demoralising the entire workforce. This response often robs them of their best talent during an already difficult period. Leaders can opt instead, to motivate and energise their organisations by communicating an inspirational change story.

Discerning the opportunity inherent in ensuring outstanding quality, and proactively working towards quality goals can transform a company. Leaders must take up the quality agenda as their very own—no longer can they delegate it to others in the organisation. They are the Chief Quality Officers, and their commitment to quality can determine the path and destination for the organisation as a whole.

References 1. Press Information Bureau; “Affordable Efficacious Medicines – All Roads Leads to India” report by IDMA; Brandindiapharma 2. UK and India regulators agree deal for closer collaboration to improve public safety, Government of UK press release, 5 October 2015 3. US FDA website 4. US FDA database 5. McKinsey POBOS quality benchmarking, Industry-wide benchmarking of pharma quality 6. www.nseindia.com; press searches; McKinsey analysis 7. Customer surveys by an automotive OEM; Based on 900,000+ responses 8. POBOS Quality survey; ISPE Quality Metrics pilot Jul 2014 – March 2015

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cover ) INSIGHT

Pharma quality and compliance: Has the 'elephant in the boardroom’been recognised?

SM MUDDA Chairman, Regulatory Affairs Committee, IDMA

SM Mudda, Chairman, Regulatory Affairs Committee, IDMA, Mumbai examines where India’s pharma industry stands in terms of current expectations of the regulatory authorities and the state of GMP compliance in the sector ACHIEVING QUALITY excellence seems an elusive goal for the pharmaceutical industry. It reminds of the story about six blind men trying to figure out the elephant in the room. Before answering the question posed in the title, let's recapitulate what was expressed in my earlier article, 'CGMP implementation From Philosophy to Practice,' which had appeared in the GMP Special issue of Express Pharma in March 2014. It would help us take stock of where we stand in terms of current expectations of the regulatory authorities and the state of GMP compliance.

Meeting regulatory expectations Nothing much has changed as far as regulatory expectations are concerned. The focus of inspection, finding how companies reacted when things went wrong or were changing under pressure, remains the same even now. It was expected that the companies would do a detailed investigation of the failures to find the root causes rather than just building arguments for release of the products. The investigations doesn’t seem to have met the required standards, with particular reference to complaints, rejects, deviations and out-of- specification data. No significant changes are seen in this area either.

The emphasis on top management responsibility continues to remain a major expectation from the regulators, as evidenced by the following statements from Dr Janet Woodcock, Director, CDER, US

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FDA. She states, “Pharma quality management is lacking and we are not anywhere near where we need to be. And it seems as though industry’s objective today is to continue to meet regulatory standards which are minimal expectations, versus adopting a commitment to high-quality medicines. A large number of recent manufacturing failures can be traced to failures in the form of quality management system (QMS).

In some cases, the QMS ignored and failed to follow-up on customer complaints. In other cases, multiple repeated deviations were treated as separate incidents, rather than an obvious trend. Another recurring theme has been investigations 'to nowhere', concluding with no additional understanding or insight into why the problem may have occurred and thus no hope for prevention. All of these failures suggest a QMS that is insufficiently empowered or resourced to adequately to carry out its essential functions”.

Current state of GMP compliance Failure in carrying out investigations with an intent to identify the true root cause and lack of management responsibility continue to remain major concerns as seen from the various deficiencies reported and warning letters issued in the last two years. Despite implementation of remedial measures by the companies with assistance from eminent consultants, a resurgence of data integrity and quality issues are plaguing our industry. In 2015 alone, findings from 218 major inspections done

by The Medicines and Healthcare Products Regulatory Agency (MHRA) and a significant number of USFDA warning letters have cited data integrity issues, predominately related to the laboratory systems.

A significant concern is that companies which failed inspection initial but were given a clean chit after implementation of CAPAs have found themselves in deeper trouble in subsequent inspections. As if this was not enough, the indirect regulatory actions arising out of the failures of suppliers/ vendors, contract testing laboratories and clinical research organisations (CROs) have aggravated the issue; leading to a sudden and unexpected impact on the business. It appears as though we are not sure of the outcome of the next inspection and our GMP compliance continues to remain consistently inconsistent.

The industry continues to remain at a tipping point. The question that needs to be asked is, “Are doing more of the same because we need to find a quick solution or are we focusing with a learning mindset on something better and different because it is a right thing to do?”

The tipping point Adopting a good quality, system-based approach for compliance with GMP continues to remain at the top of the industry's agenda. However, support from the top management for a paradigm shift in its approach towards GMP compliance is yet to be demonstrated in full measure. Whatever has been done in

these areas appears to be reactive and inadequate for the challenges we are facing. The power of a quality system as a foundation in creating a sustainable culture of quality has not been fully realised at all levels in the organisation. This has led to a piecemeal and need-based adoption rather than being regarded as the philosophy behind the practices and a key driving force for compliance.

it is not possible to integrate the activities of all functions.

Improving them in isolation will not improve the system.

Is pharma quality like an elephant in the dark?

New initiatives from the industry

In a recent blog post, Dr Ajaz Hussain, an eminent thought leader in the areas of quality and compliance, with an understanding of both the worlds, India and the West, underscored the importance of adopting a systems-based approach by posing the right question, 'Is pharma quality like an elephant in the dark?, and has equated it to the story of six blind men touching and describing what they observed in the dark. None of the versions came close to describing the elephant. This is quite similar to our inability to share our observations with others from various functions within the company and finally integrating the information through a well-designed Pharmaceutical Quality System (PQS) to complete the whole picture i.e. to understand the real contributing factors and the root causes that have been identified by the regulators as expressed eloquently by the CDER Director in her statements reproduced above.

A system is the product of interacting parts. Unless a quality systems approach is adopted

It is heartening to see that there has been a significant change in the mindset of industry leadership in acknowledging the enormity of the issue involved and initiating preventive measures at individual company level and also at the industry level collectively. There is a clear understanding that the underlying reasons for failures are more behavioural than technical. The challenge now is to create a second level of leadership who can represent the top management's intent in letter and spirit and convert it into a concrete action plan for implementation.

The individual companies have adopted many technical measures such as automation of systems, control on electronic data and education of the personnel for building the required skills needed to ensure consistent compliance.

Likewise, the industry has started various initiatives to ensure that there is an industrywide focus and commitment at creating a culture of quality. For example, IPA’s Quality Forum is working on bringing the large companies together to address

Deming’s 94/6 Rule The following quote from W Edward Deming conveys the importance of systems-based approach. He says, “94 per cent of the problems in the business are system-driven and only six per cent are people driven.”

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The issues related to data integrity continue to be a main topic of concern and interest. A data governance system is being implemented at many companies the issues and to jointly develop solutions. The Quality Forum has been formed with a clear structure and roadmap to help the Indian pharma manufacturers achieve global benchmarks in quality.

There is also increasing focus on developing and using quality metrics for assessing the level of compliance in the industry by identifying meaningful leading and lagging indicators.

Quality metrics is going to be an important monitoring tool during the management review of quality.

The issues related to data integrity continue to be a main topic of concern and interest. A data governance system is being implemented at many companies. It is considered as an integral part of the company’s quality system. An organisation-wide awareness is being created to understand the importance of data quality and integrity in patient safety. The industry has recognised that an environment which encourages transparent and fearless reporting of failures is key to maintaining data reliability.

However, misconceptions on issues related to data integrity and breach of data integrity has to be resolved to remove excessive concerns/fear associated with them. Stan Woollen of US FDA coined the acronym ALCOA that stands for Attributable, Legible, Contemporaneous, Original and Accurate to identify elements of data quality. Non-compliance with any of these data quality attributes is at times likely to be interpreted as breach of data integrity.

Such interpretation without adequate investigation to identify the root cause in failure to meet the requirement of data quality has to be avoided by all. Constant education about the differences and proactive transparent engagement with all employees and regulatory agencies will help resolve the misconceptions.

Another key issue that requires immediate attention is education of the employees at various levels. This need has been identified from the

findings of various surveys and several activities are being initiated by the industry in this direction.

Investment in education – Need of the hour A survey conducted by management consulting firm Ernst & Young identified lack of education and emphasis on quantity over quality as key root causes of data integrity issues. Often, employees were not educated or trained to understand GMPs. This caused employees to consider activities as a chore rather than understanding their relevance in light of GMP. Another survey, ‘Managing Growth Through Better Compliance Management,’ got responses from 33 pharma groups in the country where more than 64 per cent said that lack of skilled people to manage compliance was a key drawback. The survey found that 55 per cent of those responding believed their compliance teams were not sufficiently trained.

“There is an urgent need for more effective training, coaching and mentoring – to remove fear and empower the employees,” states Dr Ajaz Hussain, Executive Director, NIPTE, US in one of his articles.

The need for education of the personnel has emerged as one of the important corrective and preventive measures to maintain a state of compliance. Education, thus is being considered as a strategic investment to prevent non-conformance. Any cost incurred for compliance through preventive measures will eventually save the cost of internal and external failures. It follows a ratio of 1:10:100 thus proving it as a wise investment.

IDMA's initiative Indian Drug Manufacturers’ Association (IDMA) has introduced several education initiatives realising the need to strengthen the capabilities of the personnel. The Department of Pharmaceutical (DoP), Ministry of Chemicals & Fertilisers has initiated a nation-wide GMP training programme in partner-

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cover ) ship with IDMA for helping the SMEs to voluntarily upgrade the GMP standards to the current global standards. The programme titled, 'GMP workshop for SMEs – Schedule M & beyond' has been designed by IDMA and DoP and so far workshops have been conducted successfully in six different cities. Similarly, a new training programme called, 'Meeting Quality Challenges & Achieving Global Compliance' has been jointly planned by DOP and IDMA in the current year and will be conducted in four cities in India.

IDMA has also realised the need for training industry professionals with a specific focus in modern PQS since they are at the forefront in representing the management’s quality intent from inspection to resolution of deficiencies and implementation of corrective and preventive action (CAPAs). In the wake of ever increasing regulatory bar, expectations from quality assurance (QA) professionals for demonstrating an ongoing compliance with GMPs have increased. Lack of formal education of our QA professionals in concepts of quality management is found be one of the key areas that requires an immediate remedial measures.

IDMA has planned to collaborate with leading UK-based GMP consultancy and education firm NSF Health Sciences (formerly known as David Begg Associates-DBA), leaders in pharma quality and technical education and pioneers in quality management and culture building to provide a formal education in best-in-class PQS to the industry professionals to help them deal with the current expectations.

An Advanced Executive Course in Pharmaceutical Quality Management System (PQM) has been designed on the framework of Qualified Person (QP) training course by NSF and IDMA. The course includes practical modules and case studies built on current focus areas as a part of the training to get hands-on experience. Preeminent trainers with specialist experience, including ex- MHRA

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The realisation that adoption of PQS and risk-based approach is vital to the success of the business has to be percolated down to all levels in the organisation inspectors who provide the training for QPs in the UK with an unsurpassed success rate of 98 per cent will provide the education in India. The course is designed for a duration of 10 months with an examination to certify successful participants.

While the certificate in PQM will provide formal recognition to an individual for demonstrating proficiency in PQS, it will also help the company to protect its reputation as a supplier of quality medicines and earn regulators' trust and respect.

Besides, greater efficiency will lead to improved profit margins.

It will create an environment in the company that will attract and retain the best people.

This initiative of IDMA is a plan for providing concrete long term education programme that will build the strength of quality professionals across the industry with a formal certificate of international standards and an ability to match global professionals.

Deming’s 14 principles and obstacles for transformation While all the above initiatives are laudable, we need to understand that most of these have been reactive measures adopted in the face of challenges encountered in the last few years.

While they have been benefiting the industry to ensure sustainability of these initiatives and consolidate the benefits, the industry is required to go through a transformation before it adopts proactive measures successfully. The lessons from Deming’s book 'Out of the Crisis' show us the way forward.

While it is realised and accepted that top management engagement and support is necessary, Deming states, “It is not enough that the top manage-

ments commit themselves for life to quality and productivity but they must know what they are committed to – that is, what they must do”. Quite often the management support is demonstrated by instituting a quality program that is ceremonial in nature. The actions can't be in the nature of ceremonial support but have to be concrete.

The following statement from his book emphasises the importance of actions. “A quality programme for a community, launched by ceremonies with a speech by the governor, raising of flags, beating drum, badges, all with heavy applause, is a delusion and a snare."

Such programmes can give an impression of progress being made but in reality unless supported by concrete actions the benefits will elude us. It is therefore necessary to learn from teachings of Deming and follow his 14 principles for management of quality to overcome the following obstacles that stand in the way transformation: 1. Lack of constancy of purpose 2. Emphasis on short-term profits: Profits follow good products. Short-term thinking the opposite of constancy of purpose - in order to stay in business may lead to cutting of expenses related to long term goals such as: training, quality assurance management, maintenance, etc.

3. Performance–based evaluation: It nourishes short term performance, stops long term planning, builds fear (management by fear), destroys teamwork, nourishes rivalry and politics. The effect is exactly the opposite of what it promises. It has to be acknowledged that apparent difference between people arise almost entirely from action of the system that

they work in, not from the people themselves. Modern principles of leadership should replace the annual performance review and therefore the first step in the company should be to provide education in leadership. More careful selection of people in the first place, better training and education after selection will be the way forward. A leader instead of being a judge, will be a colleague; counselling and leading his people on a day-to-day basis, learning from them and with them.

The performance- based evaluation was identified as one of the potential problems by Dr Ajaz Hussain in his interaction with the industry and he has stated in his article, “There is a tendency to incentivise outcome rather than the process of getting the outcome and that is the potential problem”

Conclusion It has often been said that 'Quality is too important to be left to the quality controllers alone'. The significance of the statement is realised in the present circumstances where focus on the management aspects of quality rather than adherence to inspection-oriented practices is of paramount importance to remain in state of quality and regulatory compliance. The focus thus has to be on making quality as a primary objective of the company and all efforts should be on single-mindedly achieving this objective by overcoming the obstacles discussed above that stand in the way of transformation. The significant learning from Deming’s teaching that quantity driven key performance indicators (KPIs) have to be replaced with key behavioural indicators (KBIs) to build a strong leadership for quality in the organisation has to be put in practice.

The realisation that adoption of PQS and risk-based approach is vital to the success of the business has to be percolated down to all levels in the organisation.

This new learning coupled with a focus on implementation of the following initiatives will help regain the trust of the customers and the regulators alike. ◗ Development of second level leadership through on-going education initiatives ◗ Creating an environment of fearless reporting of failures ◗ Objective, independent retrospective investigations of the failures to identify the actual underlying technical and behavioural contributing factors, impact assessment of the findings on the quality of products and implementation of appropriate CAPAs ◗ Transparent documentation and reporting of the findings to the regulatory agencies ◗ Creating a governance system for ensuring reliability of data (Data Integrity) and ◗ Introduction of a robust and meaningful quality metrics that provides information of lagging and leading indicators for management review of quality.

This approach has paid good dividends to some of the major companies who have been able to come out of crisis. If this model is followed by other companies, which certainly is happening, we can take real pride in our being a Pharmacy to the World.

References 1. Out of the Crisis – By W.E.Deming 2. Ajaz’s Insights on Pharmaceutical Technology Education, Training and Experience for the 21st Century 3. Pharmaceutical Quality: Elephant in the Dark or Six Blind Men – By Dr.Ajaz Hussain, Founder, Insight, Advice & Solutions, USA and President NIPTE, USA. 4. Data Integrity Survey- By Ernst & Young 5. Managing growth through better compliance management – By Delloite 6. Articles and Presentations By Mr. Martin Lush, President, NSF Health Sciences, UK.

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Minimise Handling.

Minimise Damage.

INSIGHT

Indian pharma: Bad at GMP compliance or victim of unwarranted regulatory expectations?

Viranchi Shah, Vice Chairman, Indian Drug Manufacturers’Association (IDMA), opines that India's role in global healthcare cannot be decimated or questioned only due to recent concerns but cautions that India cannot ignore any international concern on quality, and must do all it can in order to maintain its dominance in the global pharma map

I

ndia is world’s biggest source of generics and branded-generic formulations. India caters to the major pharma needs of over 200 countries across the globe. Indian companies have dominating presence in the developing world. Indian products have wide acceptance and affordability in these markets. The Indian share is quite significant in the generic marketsof the developed world, including the US and EU markets. Around 40 per cent of ANDA approved by US FDA are from India. Can a country conquer such massive share and command, if its manufacturers have such a bad GMP compliance culture?

On the other hand, we read about unfavourable comments from regulatory authorities such as USFDA and MHRA after audits of Indian plants.

These observations question GMP compliance by some of the leading Indian companies. Most of the red flags relate to data integrity, laboratory controls, investigation systems, training systems, validations and

VIRANCHI SHAH Vice Chairman, Indian Drug Manufacturers’ Association (IDMA)

documentation controls. These are common instances of non compliance which are highlighted in several audits, and raise eyebrows about the the overall culture and practices prevailing in India. In the last two years, products from several Indian API and formulation companies have been subjected to some form of restrictions or watch

by US and European regulators.

Are these regulators over reacting, or do they really have cause for concern? Doesn’t this highlight that something is really wrong with the GMP culture across the nation?

Indian pharma industry is a global player with over 50 per cent

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cover ) revenues coming from international markets. Exports have consistently grown much faster than the domestic business. Today, India exports over $17 billion worth of pharma products annually. A lot of capacities are being expanded and newer ones are being built.

Therefore, India cannot ignore any international concern on quality, and must do all it can to maintain its dominance in the global pharma map.

Entrepreneurs must understand that standards are upgraded with every wink.

The science is getting more refined each day. Technology brings in newer dimensions.

Regulatory expectations are going up every day. When we speak of ourselves as one of the global leaders in the pharma industry, obviously the expectations are even

The path to success lies in a proactive approach towards compliance. The goal should not be limited to the absence of any form of GMP non-compliance, it should be proactive compliance to the latest GMP requirements. Quality managers need to be thinking about tomorrow higher. The goal post is changing each day, and we need to continuously change our directions to reach it. The quality or GMP standards are not limited to quality, but are getting more and more complex.

The path to success lies in a proactive approach towards compliance. Companies aspiring to be global, need to bring

in the right professional talent from the front door. These talented pool of professionals need to be given the right message- we need proactive compliance. The goal should not be limited to the absence of any form of GMP non-compliance, it should be proactive compliance to the latest GMP requirements. Quality managers need to be thinking

about tomorrow.

Investing in the latest technology and talent is a must. Commitment to proactive compliance, not just by way of quality policy but also through actions is more than necessary. Managerial review of quality trends and compliance are critical. Company managements must understand that the cost of non-

compliance is much higher than the cost of compliance.

Though there is a lot of talk over GMP compliance, most experts believe that Indian companies have a good track record when it comes to product quality. Most audits do not reveal any serious concerns on the final quality of Indian products. Indians have also benchmarked affordability of medicines.

Indian companies have been succeed due their ability to produce good quality products at very affordable prices, since decades. Indian role in global healthcare therefore cannot be decimated or questioned only due to recent concerns. But yes, the future is bleak if these concerns are not promptly addressed.

Those who will fail to address these issues will soon fall into stagnation and decline.

INSIGHT

Tackling GMP non-compliance: Atop priority!

Suresh Pareek,Managing Director, Ideal Cures emphasises the importance of eliminating GMP non-compliance and points out that its responsibility lies with each employee in an organisation

C

ompliance with cGMP regulations is always a priority and obviously the cost of non-compliance is higher than ‘cost of compliance’. Due to non-compliance, the company not only suffers in fines and loss of business in terms of potential exports but also ruins the image and goodwill it has earned after years of hard work. Hence, it is not only the responsibility of the senior management, but of every individual to make sure that regulations are followed and the necessary requirements are met.

GMP regulations are guidelines to develop systems which ensure that manufacturing facilities and processes are properly designed, monitored

30 EXPRESS PHARMA May 16-31, 2016

and controlled, ensuring that finished products are effective and safe for market distribution. It is time we truly understand the importance of following the guidelines that have been established by the regulatory authorities.

India has become the biggest foreign supplier of medicines to the US. It accounts for nearly 40 per cent of generic drugs and over-the-counter products as well as 10 per cent of finished dosages used in the US. Huge competition in the market and shortage of time are some of the reasons for increasing issues of non-compliance in India. The absence of global harmonisation of quality systems makes it all the more

challenging for India as it exports to the US, Europe, Australia, Japan, etc, to comply with a plethora of global regulatory guidelines across diverse geographies and may sometimes fall short of regulatory expectations. With all this, one also has to note that the pharma and excipient sectors are growing at a very fast pace, and it has resulted in shortage of skilled staff at various levels.

Lack of proper training to the existing group of employees is also one of the important issues that arise during GMP audits. It is important that the standard operating procedures (SOPs) are made to exactly reflect the actual processes that are followed

and the people involved at the worker level, junior research associate level etc. are aware of the importance of following each step exactly according to the requirement. It is also important that they understand that SOPs are not just documents but guidelines to help them do their work efficiently. Knowledge and understanding of the SOPs and maintenance of log books by writing down every detail will help resolve the issues relating to non-compliance of documentation. These issues can be easily dealt with by designing periodic training programmes, specifically suited to help the individual to effectively perform his assigned duties.

SURESH PAREEK Managing Director, Ideal Cures

Alternately, the manufacturers also have to understand the long term benefits of investing in trained people and facilities. Help from external quality consultants should be welcome, but it is also important to note they can only point out the areas where change is required. Ultimately, it all circles back to the persons actually involved.

A change in attitude is of utmost importance. Once we change our perspective about the situation in question, only then can we bring the necessary changes. With implementation of certain small and concrete steps the issues faced with GMP compliance can be addressed and future mistakes can be avoided.

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INSIGHT

Battling non-conformance to quality Michael Payne, Principal Technical Consultant, Process Solutions, Merck elaborates on the need to evaluate the quality systems in pharma organisations and plug the gaps to reduce non-conformance and risk SOME OF the possible causes of non-conformance include lack of a robust quality culture, low maintenance of an effective quality system, lower investment in quality, an increased focus on immediate financial aspects of pharma manufacturing, overestimation or overconfidence in the quality system, ineffective implementation of process analytical technologies, and a lack of understanding of the benefits of learning from other manufacturers inspection experiences around the world.

By reviewing the roles and activities of regulators, the foundations of modern-day quality systems, quality by design and quality risk management, and some the information available about inspectional observations and trends, this article will hopefully provide fuel for thought and a stronger appreciation of a robust and effective quality system that reduces risk and increases conformance.

Role of the regulator The regulator is the agency responsible for the protection of the health of the public whose government the regulator represents. As such they have an inherent interest in many areas like: Development of new and innovative medicinal products, medicine and healthcare product manufacturing, distribution of medicines and helping to ensure the continued supply of medicines and healthcare products now and in the future.

An example of the charter of a regulatory agency is the UK MHRA which states1 that the agency “regu-

MICHAEL PAYNE Principal Technical Consultant, Process Solutions, Merck

lates medicines, medical devices and blood components for transfusion in the UK. The agency is responsible for: ensuring that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy, ensuring that the supply chain for medicines, medical devices and blood components is safe and secure, supporting innovation and research and development that’s beneficial to public health.”

Similarly, the US FDA states2 that it is “responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable”.

The desire for cost effectiveness however cannot reduce the five critical aspects of drug products and substances: efficacy, strength, safety, quality and purity.

Regulatory support for industry improvement Over the past 15 years, regulatory agencies such as the US FDA have

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cover ) actively encouraged and cajoled the industry to move away from the exclusive use of traditional equipment, tools, methods and approaches towards the incorporation of new production and analytical technologies and risk assessment concepts. This was to support the industry in driving down the cost of nonconformance and reducing patient risk.

In 2004, the US FDA published3 'Pharmaceutical CGMPs for the 21st Century – a Risk Based Approach' with the desired objectives including the encouragement of the pharma industry to adopt new technological advances, the application of modern quality management techniques, the implementation of quality systems and of riskbased approaches. At the same time, the document was to help ensure that the US FDA’s regulatory review, compliance, and inspection policies would be based on state-of-the-art pharma science.

Two years later Dr Janet Woodcock4 gave the US FDA’s view of the desired direction of the pharma industry when she said that the desired state is 'a maximally efficient, agile, flexible pharma manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight'.

Now over 10 years later, the major regulatory agencies have adopted ICH guidelines including ICH Q8 (Quality by design and the design space concept), ICH Q9 (Quality Risk Management) and ICH Q10 (Robust Quality Systems). The concept of quality by design (QbD) is a 'systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management'.5 The four design spaces can be seen in the figure shown above. Since there is data collected by the drug substance or drug product manufacturer during the development and scale-up phase, the design space delineates the boundary where the product or substance has known efficacy/safety/pu-

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Figure 1

Unexplored Space — nothing is known of similar products or substances

Design Space - where manufacturing data exists on the product or substance

Control Space -normal operating range for manufacturing

Knowledge Space - prior knowledge from available documents of similar product or substance manufacturing

a process based on the understanding at time process was developed and 'finalised' is not as robust as the collection and analysis of data from proactive and iterative activities throughout the process lifecycle. In a traditional approach, a deviation is seen as a setback and in certain less robust quality organisations is can be something to be explained away. With the increase in analytical tools, understanding of the effect of raw material and process variability, a deviation can provide an opportunity to increase process understanding and avoid failures later on during commercial manufacturing.

Change drivers rity/strength and quality. If the manufacturing process accidentally drifts outside the control space, there is no need to raise a change since working within the design space is not considered to be a change. This reduces the risk to the patient, and reduces the incidence of product or substance non-conformance.

Table 1: 2012 data from PICS7 also shows similar areas of deficiency 1.

Investigation of Anomaties

2.

Quality Management

3.

CAPA

4.

Contamination: Chemical / Physical (or potential for)

5.

Supplier and Contractor Audits

Risk management and effect on validation

6.

Change Control

The principles of quality risk management (QRM) is present in regulatory guidelines such as ICH Q9, EMA volume 4 Annex 20, WHO Guideline on Quality Risk Management, etc. along with a number of industry and research association documents.

One of the outcomes of the combination of a quality risk management approach and a quality by design approach is that traditional validation concepts are challenged. The idea of three sequential qualification runs is not considered to be based on science. With QbD principles, a different number of runs may be required to show that the process is operating in the defined control and design space. The same principle does not require operation at a predetermined set of specific datapoints and so a triplicate set of moist heat sterilisation operations at (say) 126oC may not prove the robustness of the sterilisation process.

Similarly, a demonstration of

7.

Documentation Procedures / PSFs / Tas

8.

Personnel Issues : Training

9.

Design and Maintenance of Equipment

10.

Documentation : Manufacturing

11.

Finished Product Testing : Chemical Table 2: Summary of top 11 most frequently cited categories of GMP deficiencies

Rank

Area

Citations

1.

Documentation – manufacturing

24

2.

Design and maintenance of premises

22

3.

Documentation – quality systems elements / procedures

20

4.

Personnel issues – training

19

5.

Design and maintenance of equipment

18

6.

Cleaning validation

14

6.

Process validation

14

6.

Product Quality Review

14

7.

Supplier and contractor audit

13

8.

Calibration of measuring + test equipment

12

9.

Equipment validation

11

There are a variety of drivers that can trigger the need to re-evaluate pharma production processes, risks and the robustness of the company’s quality system. These include: ◗ Results of regular internal reviews and self-audit programmes ◗ Product annual or product quality review ◗ Routine SOP revisions and updates ◗ Change controls ◗ Changes in national or international regulations ◗ A change in the national inspector training process ◗ External reviews from potential technology transfer partners ◗ Regulatory/compliance/licensing inspection results ◗ Preparation for regulatory inspection These reinforce the concept of current GMPs (cGMP) versus GMPs and support the company’s focus on maintaining quality, reducing risk, achieving acceptable cost of goods, reducing non-conformance and reducing patient, product and company risk.

Learning from others – Regulatory inspection trends As mentioned above, one of the change drivers is the information available from MHRA, PICS, and US FDA about warning letters, inspectional observations, compliance trends etc. Much of this can be

( accessed on the internet using regulatory sites such as the FDA Inspection Observations.

At least one large contract manufacturer uses the inspectional observations as a continuous learning tool for the personnel in their facilities.

Each relevant observation is sent out via email so that all production, quality, engineering and facilities personnel can see what has been reported and so trigger attention to the possibility of the same issue occurring in their facility. Actions like this ensure that cGMPs, continuous improvement, quality ownership and the maintenance of a quality culture are in everyone’s mind.

The most recent inspection data available from the MHRA is from 20136. The top 10 areas of deficiency is shown in Table 1.

An example of inspection trends can be seen in a comparison of FDA observations from 2014 and 20158. (Check Table 3).

As can be seen, the relative percentages are consistent across the two years with the exception of a significant increase in the number of observations in the design and construction aspects of buildings and facilities.

An unbiased and open review of information is of real benefit to companies seeking to practice continuous quality improvement, reduce inspection observations and to reduce patient and product risk. This information should not be used as a 'checklist' with the purpose of showing that the current procedures and practices are acceptable. Each observational category should be reviewed by a multidisciplinary group of employees with the idea that these areas will be openly assessed with an unbiased view, since this approach is most likely to generate the greatest increase in learning and in potential quality and risk improvement.

Example of stronger future focus - Data integrity A review of information from the FDA, EMA and PICS shows that data integrity was flagged as an area of concern as early as 2008 as a result of inspections carried

THE MAIN FOCUS

TABLE 3: COMPARISON OF TOP 13 US FDA INSPECTIONAL OBSERVATIONS FOR 2014 -2015 Year Total Drug 483s Total Observations

2014

2015

645

678

2800

3500

Section

Description

21 CFR 211.160

Subpart I: Laboratory Controls – General requirements

8%

8%

21 CFR 211.42

Subpart C: Buildings & Facilities – Design and construction features

5%

8%

21 CFR 211.192

Subpart J: Records & Reports – Production record review

7%

7%

21 CFR 211.22

Subpart B: Organization & Personnel – Responsibilities of quality control unit

8%

7%

21 CFR 211.100

Subpart F: Production & Process Controls – Written procedures; deviations.

6%

6%

21 CFR 211.113

Subpart F: Production & Process Controls – Control of microbiological contamination.

5%

5%

21 CFR 211.67

Subpart D: Equipment – Equipment cleaning and maintenance.

7%

5%

21 CFR 211.165

Subpart I: Laboratory Controls – Testing and release for distribution.

5%

5%

21 CFR 211.166

Subpart I: Laboratory Controls – Stability testing.

4%

4%

21 CFR 211.84

Subpart E: Control of Components & Drug Product Containers & Closures – Testing

3%

4%

21 CFR 211.68

Subpart D: Equipment – Automatic, mechanical, and electronic equipment.

4%

3%

21 CFR 211.198

Subpart J: Records & Reports – Complaint files.

3%

3%

21 CFR 211.25

Subpart B: Organization & Personnel – Personnel qualifications.

4%

3%

69%

68%

Top 13 observations as percentage of total obervations

out in North America, Europe and the rest of the world. All regulatory agencies have found evidence of data integrity issues including: 2012 WHO prequalification inspections that found evidence of incorrect and inconsistent data manipulation, data falsification, and raw data that was lost or destroyed.9 2013 PICS7 reported finding inspection deficiencies such as: ◗ recording data in logbooks, falsification of batch records and test results, pretesting samples and ignoring or not investigating out-of-specification results, ◗ blending or mixing batches that failed to meet the established released specifications with batches that met the required final specifications, ◗ ineffective controls in handling and managing critical data, and entering manufacturing activi-

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ties on records before they had occurred.

In 2013 the MHRA announced10 that they were 'setting an expectation that pharma manufacturers, importers and contract laboratories, as part of their self-inspection programme must review the effectiveness of their governance systems to ensure data integrity and traceability.

This aspect will be covered during inspections from the start of 2014, when reviewing the adequacy of self inspection programmes in accordance with Chapter 9 of EU GMP.' This information is very valuable for relevant pharma manufacturers to allow them to check and if necessary correct data handling practices, quality systems and shortcomings in quality culture.

Conclusion Inspectional observations and trends can provide a valuable source of material to help pharma companies reduce non-conformance, increase efficiency, reduce costs and strengthen their quality systems. Newer approaches such as process analytical technologies, quality by design, quality risk management, and quality metrics can be used to ensure that procedures and products maintain a high level of safety, purity, efficacy, and strength.

References 1. www.gov.uk/government/organisations/medicines-andhealthcare-products-regulatoryagency/about 2. www.fda.gov/AboutFDA/ WhatWeDo/ 3. www.fda.gov/downloads/ Drugs/DevelopmentApproval-

Process/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM176374.pdf 4. Janet Woodcock, M.D. - CMC Workshop (October, 2005) 5. ICH Q8 www.fda.gov\downloads\Drugs\Guidances\ucm0735 07.pdf 6. www.mhra.gov.uk/home/ groups/pl-a/documents/websiteresources/con464241.pdf.

7. www.sindusfarma.org.br/arquivos/apresentacao_helena_pau la_baiao.pptx 8. www.fda.gov/ICECI/ Inspections/ucm250720.htm 9. apps.who.int/prequal/ trainingresources/pq_pres/ ManufacturerMeeting2012/ Ian_Thrussell.pdf 10. www.mhra.gov.uk/ Howweregulate/Medicines/ Inspectionandstandards/ GoodManufacturingPractice/ News/CON355490

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cover ) INSIGHT

Setting up greenfield projects: Doing it the right way!

VILAS DHOLYE Independent Pharma Consultant

Vilas Dholye, Independent Pharma Consultant outlines the measures that need to be implemented at the planning/construction stage of a greenfield project to avoid issues of noncompliance to quality standards and lose out on growth opportunities

W

e read news about greenfield projects being set up by pharma companies to scale up their operations. It will be interesting to see how companies handle this project phase and subsequent operations phase life cycle of new site. While views expressed are relevant to all types of industries, I have written this paper with pharma API/fine chemicals and formulations manufacturing in mind.

Most of the greenfield pharma projects (which may involve capital investment in the range of `100 to 700 crores) focus on engineering and construction aspects majorly and are essentially monitored by senior managements on the following two aspects a) Completion time and b) Budget Scope of these projects largely revolves around creating physical infrastructure. These projects are also designed for substantial expansion (2X or more) in future.

How do we manage projects to operations phase?

Sometimes, during the advanced phase of a project (almost towards the completion of construction), the site operations teams, including manufacturing, quality, maintenance, stores, HR, Finance, SHE are gathered/hired, and sent to the site. The team is expected to decide and evolve the site operation management processes, structure, operations philosophy etc. Similarly, QM and GM processes are evolved with learnings from your own organisation or from other pharma

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companies. This situation occurs since project departments which are responsible for project execution and the EPC consulting agencies which handles design and engineering have no scope, mandate and expertise in operations management and QM/GMP processes design.

What is the result?

This haphazard situation results in the loss of a lifetime opportunity to start a new site with the right culture, processes, and practices. While one may purchase the best of the equipment available and use the latest automation ideas, the operation results fall short of expectations.

We know that significant adverse audit observations from leading regulators are not attributed to equipment and facilities but due to failure of the staff to observe compliance, which is more of a cultural issue. A key component for continued GMP/statutory compliance is having the right culture and this must be the focus while planning a greenfield project.

After a few years in operation, unless the right measures are put into place, many problems faced by an organisation’s existing plants start manifesting at the new site. New problems also surface. However, over the years, many changes in operations and quality leadership, both at the corporate and plant level may result in significant changes (improvements).

Some problems commonly faced by these plants in operations are listed below: A) GMP and operations management:

1. Use of contract manpower in core manufacturing leading to issues in GMP compliance /housekeeping/safety/IR 2. Variability in lead time, yields, quality parameters 3. Poor learning from problems, poor CAPA skills.

4. Poor maintenance management practices.

5. Process capability 6. Outsourcing activities like housekeeping, warehousing, testing, maintenance, IT 7. Documentation and data integrity 8. Lack of training.

9. Too much variety in machinery sizes/types/makes for the same operation, leading to high maintenance/spares/loss of capacity as all products do not work or are not validated on all types of machines. (e.g. compression machines, coating machines, packaging machines on the same shop floor!).

Such problems occur because of reasons such as: (1) Saving on Capex (2) Respecting the policy of getting three quotations (3) Respecting the experience of newly joined managers from other industries!

B) Operations management 1. Too much manpower, manpower productivity is low 2. No proper structure and HR systems, leading to confusion, low morale and performance and retention problems 3. No proper metric to monitor plant performance 4. Low capacity utilisation and low machine productivity 5. High cost of operations, materials, utility, consumables etc.

6. High lead times in

manufacturing 7. High inventory RMs/PMs, WIP and FG

in

What needs to done to correct the situation at this stage?

At this stage, top management decides to engage expensive management consultants and GMP consultants to study and recommend solutions to address the above issues. Consulting companies may spend few months studying the situation and come up with many recommendations. However, implementation of these recommendations require major change management.

Sometimes, changes are not possible due to limitations of physical infrastructure or teams’ limitations.

It is also an expensive endeavour at times, particularly when physical changes are required. At the end, the improvement efforts cease, resulting in partial gains or success.

Addressing the problems at the project stage Many of these problems could have been addressed if proper management and GMP/QM processes had been put into place when the project was being set-up.

If the following steps are taken during the planning or the construction stage of a greenfield project, we could avoid such issues in future and will help create a sustainable performance culture for the new site: 1. Create a vision for the greenfield project to ensure that it remains topnotch, not only in technology and engineering but also in management practices

and GMP adherence. It will remain competitive over, say the next 10 to 15 years with built in processes which are sustainable and aids continuous improvement.

2. If this greenfield project is for a company which already has manufacturing operations then there will be a wealth of knowledge as to what practices must be avoided and what must be retained. This will involve the study of all the units of the company, regardless of the product lines. Coupled with this internal knowledge, we must also bring outside views from other diverse industries (e.g. automotives/electronics/chemicals) to choose and assimilate best practices.

3. The above study will help create a blueprint for the management, and decide the master plan and strategy for operations.

This must be presented to the top management for their approval. Post approval, this becomes like a ‘Constitution’ for the site and in future, plant teams cannot deviate from the basic philosophy .

4. Management systems recommended above will dictate the technical design choices e.g. batch sizes, inventory/storage policy, material handling, automation, IT systems to drive GMP and regulatory compliance (e.g. MES, LIMS), machinery standardisation, planning for smooth expansion and growth etc.

Therefore, project cost estimation and budget process must be started only after the philosophy document is created and approved.

Continued on Page 36

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INSIGHT

Information security of computerised systems for global compliance

ARJUN GUHA THAKURTA, Director – Operations, Life Science Consulting (a Convalgroup Company)

Arjun Guha Thakurta, Director – Operations, Life Science Consulting (a Convalgroup Company), emphasises on deploying an effective computerised system to defend critical electronic data and comply with quality compliance

T

he recent cases of warning letters and non-conformity reports in India, especially related to electronic records integrity issues from the regulated users, uncovered by global regulators have revived the dialogue among the industry on information security controls of a computerised system. To ensure integrity to electronic data it is essential to assure trustworthy computer systems.

It is very common in the life science industry to observe that a few years after deploying a computer system, deficient operational supporting processes and/or the incorrect implementation of such processes nullify the validated state of the computer system, causing remediation activities which sometimes take years to complete. This situation is typical across multiple computer systems and provokes a remediation project across the company, thereby adding cost to the operational life-cycle of many computer systems.

Trustworthy computer systems are the first line of defence to protect critical electronic data managed by these systems.

These computer systems consist of computer infrastructure, applications, and procedures that: ◗ Are sufficiently suited to performing their intended use ◗ Provide a certain level of availability, reliability and correct operation ◗ Are sufficiently secure from intrusion and misuse ◗ Adhere to generally accepted security principles.

The key driver of the

computer systems validation process is to ensure an acceptable degree of evidence (documented, raw data), confidence (dependability and thorough, rigorous achievement of predetermined specifications), intended use, accuracy, consistency and reliability, or in other words, ensure that the computer system is trustworthy.

Routine use of computer systems during the operational life-cycle requires procedural controls that describe how to perform operational activities.

These operational, procedural controls must be in place and approved. The execution of these procedural controls should be monitored by the pharma company to verify the accurate implementation and adherence.

These procedural controls should be reviewed on a periodic basis in accordance with the local retention policy. In addition, it is important that management should ensure that the relevant associates are trained accordingly.

Key operational procedural controls are: ◗ Data archiving: In the context of the user, archives consist of records that have been selected for permanent or long-term preservation based on their evident value. All computer system baselines should be archived in an environmentally controlled facility, as applicable, that is suitable for the material being archived and is both secure and, where possible, protected from environmental hazards. A record of all archived materials should be maintained.

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Trustworthy computer systems are the first line of defence to protect critical electronic data ◗ Data backup and recovery: A backup process must be implemented to allow for recovery of the system following any failure that compromises its integrity.

Integrity and accuracy of backed-up data and the ability to restore the data should be checked during validation and monitored periodically. The frequency of backups depends on data criticality, amount of stored data, and frequency of data generation. Procedural controls establishing the backup process must be in place to ensure the integrity of backups (secure storage location, adequately separated from the primary storage location, etc.).

This may be part of a more general disaster recovery plan. ◗ Disaster recovery and business continuity: Business continuity procedural controls, including disaster recovery procedural controls, ensure minimal disruption in the case of loss of data or any part of the system. It is necessary to ensure that the integrity of the data is

not compromised during the return to normal operation. At the lowest level, this may mean the accidental deletion of a single file in which case procedural controls should be in place for restoring the most recently backed-up copy. At the other extreme, a disaster such as a fire could result in loss of the entire system. The procedural control employed should be tested regularly and all relevant personnel should be made aware of its existence and trained to use it. A copy of the procedural controls should be maintained off-site. ◗ Infrastructure repairs and preventive maintenance: The procedural controls applicable for the preventative maintenance and repair of the infrastructure provide a mechanism for anticipating problems and, as a consequence, prevent possible loss of data. In addition to the typical infrastructure elements such as system-level software, servers, wide-area network, local-area manager, and the associated components; the infrastructure includes uninterrupted power supplies (UPSs) and other emergency power generators. Modern infrastructure hardware usually requires minimum maintenance because electronic circuit boards, for example, are usually easily replaced and cleaning may be limited to dust removal. Diagnostic software is usually available from the supplier to check the performance of the computer system and isolate defective integrated circuits. Maintenance procedural controls should be included in the organi-

sation's procedural control. The availability of spare parts and access to qualified service personnel are important for the smooth operation of the maintenance programme. ◗ Issue/incident/problem reporting: The malfunction or failure of a computer system components, incorrect documentation, or improper operation that makes the proper use of the system impossible for an undetermined period are some characteristics of the incidents that can affect the correct operation of a computer system.

These system incidents may become non-conformances. In order to remedy problems quickly, a procedural control must be established to record any computer system failures from the users of the system.

These enable the reporting and registration of any problem encountered by the users of the system. ◗ Issue/incident/problem management: Reported problems can be filtered according to whether their cause lies with the user or with the system itself and then fed back into the appropriate part of the supplier's organisation. In order to remedy problems quickly, a procedural control must be established if the system fails or breaks down.

Any failures, the results of the analysis of the failure, and, as applicable, any remedial actions taken must be documented.

Those problems that require a remedial action involving changes to any baseline are then managed through a change control process.

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cover ) ◗ System retirement: The retirement of computer systems performing control operations is a critical process. The purpose of the 'Retirement Period' is to replace or eliminate the current computer system and, if applicable, ensure the availability of the data that it has generated for conversion, migration, or retirement. ◗ System restore: A procedural control for regular testing of restoring backup data to verify the proper integrity and accuracy of data must be in place. ◗ IT security: Computer systems security includes the authentication of users and access controls. Security is a key component to maintain the trustworthiness of a computer system and associated records. Security is an ongoing element to consider and is subject to improvement. In particular, after a system has been released for use, it should be constantly monitored to uncover any security violations. Any violation must be followed up and analysed and proper action must be taken to avoid a recurrence. ◗ Training: All staff maintaining, operating and using computer systems that perform control operations must have documented evidence of training in their area of expertise. For users, the training will concentrate on the correct use of the computer system, security, and how to report any failure or deviation from the normal operating condition.

The essential practices as listed below is relevant to the security of a standalone or networked computerised system.

All applications must have a qualified authentication mecha-

nism to control access (EMA Annex 11-Principle 2). ◗ Software 'virus checking' must take place periodically to protect the applications and data. ◗ Procedural controls must be established to specify the manner in which application security is administered (ICH Q7 Section 5.44). ◗ The process for setting up access to applications must be defined and executed by the appropriate application-specific security administration personnel. The technical preparation, education, and training for personnel performing administration tasks, and associated documented evidence, are a key regulatory requirement (EMA Annex 11-2). ◗ The management of the user application accounts is a key procedural control. This procedural control includes requesting the addition, modification, and removal of application access privileges (EMA Annex 1112.3). The request is approved by the appropriate manager, is carefully documented, and submitted to the application security administration for execution of the request. ◗ There must be a procedure to grant temporary application specific access for personnel (21 CFR Part 11.10(d)). ◗ In the event that a user leaves the company, there must be a process to notify the appropriate security administration as soon as the employee departs (EMA Annex 11-12.3). ◗ A procedure must exist which defines the escalation process and actions to be taken upon discovery of unauthorised access (EMA Annex 11-13). ◗ A documented record of

security administration activities must be retained. ◗ Procedures must exist to control remote modem access to applications via the applicable infrastructure. ◗ In cases where data or instructions are only available from specific input devices (e.g. instruments, terminals), the system should be checked for, and the operator should verify, the use of the correct device (EMA Annex 11-5). ◗ When an individual has been authorised to use the system, time stamped audit trails (EMA Annex 11-9) must record writeto-file operations and changes, and independently record the date and time of the application specific operator's actions or entries. ◗ Time stamped audit trails (EMA Annex 11-9) must be used to keep track of modifications by the database administrator to the application related electronic records. ◗ The use of operational checks is recommended to enforce sequencing (21 CFR Part 11.10(f)). ◗ Authority checks (21 CFR Part 11.10(g)) must be used, when applicable, to determine if the operator can use the system, operate a device, or perform the operation at hand. ◗ The electronic records must not be altered, browsed, queried, or reported via external software applications that do not enter to the data repository area through the protective technological controls (US FDA [31], EMA Annex 11-7.1 and Annex 11-17, and TGA.) ◗ Unauthorised modification to the system clock must be prevented (21 CFR Part 11.10(d)).

One possible technological con-

trol around this item is the use of a Digital Time-stamping Service or an infrastructure that supports time stamping from a trusted time service (e.g. coordinated universal time).

Frequent deficiencies observed in computerised system documentation ◗ Missing information: Documents or records omitted fundamental information or content that should have been included. ◗ Inconsistency: Documents contained statements inconsistent with other statements about the same topic in the same document or in the same validation package. ◗ Lack of needed detail: This deficiency applied mostly to requirements documents. The requirements in the validation package did not adequately describe the characteristics of data, user interactions with business processes, or key processes internal to the software. ◗ Traceability Matrix: Frequent traceability problems are seen: ◗ The traceability matrix did not account for a traceable specification or an observation step in a test script. ◗ The trace was broken. Either a requirement was barren (lacked decedents or a test) or one of the detailed requirements or test results was an orphan (lacked a parent somewhere in the requirement tree). ◗ The traceability matrix was incomplete. Requirement details were not explicitly numbered and traced to associated test steps. ◗ Requirements were not traced at a detailed level, so the reviewer needed to infer the

detailed links between specifications and steps in a test script. ◗ Vague wording: Documents used generalities like 'in accordance to an approved procedure', or 'applicable regulatory requirements' or 'all associated GXP and business processes'. In addition, documents used vague words such as 'may', 'possibly', 'more or less', and 'approximately'. ◗ Unverifiable test results: Expected results were not described sufficiently for an independent reviewer to compare and verify actual results. For executed scripts, actual results were not recorded or captured in a way that allowed an independent reviewer to compare them to expected results. For e.g., 'OK' was noted in the actualresult column with no reference to a screen shot.

Good documentation practice (GDP) ◗ Hand-recorded data and testing evidence, such as test results, were presented in a way that could cause doubts about their authenticity (e.g., crossouts without initials, date, and reason) ◗ Data that confirmed a specific requirement was hard to find in the evidence provided (e.g., a busy screen shot crammed with data) ◗ Incomplete testing: Test scripts did not fully or adequately test the associated requirement. ◗ Ambiguity: Text could be interpreted more than one way, so it did not establish a single, unique requirement. The words 'either' and 'or' in a requirement are strong clues the text is ambiguous.

Setting up greenfield projects...

Continued from Page 34 5. Operation management should fix daily management processes for all factory functions. Shop floor production/ shift wise/weekly/monthly reports should be designed and

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MIS should be designed to manage the processes.

6. There should be also an MIS declaring every month that there are no deviations to the ‘Constitution’ or philosophy for this site.

7. Systematic people selec-

tion and indoctrinating them about the philosophy is necessary. This should apply to all levels of plant management, including the plant head! Key team members, including the plant head must be on board, right from the initial study

and project approval.

8. HR policies and practices for site must be documented 9. Every year, top management must review benefits of such project design approach and ensure that

there are no deviations to the approved constitution document without their knowledge.

Are managements ready to invest time and efforts in the above measures at the project stage to avoid future issues?

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Transforming businesses from good to great!

Dr Shruti U Bhat, Director Strategic Innovations, Continuous improvement and Training; Shifting Paradigms BC Canada elaborates on how companies can stay healthy and grow despite rapid changes such as regulatory or poor economy undermining them MY COLUMN 'Transforming Businesses from Good to Great!' is a multiple article series which gives a backdrop of sectors such as pharmaceuticals, medical devices and healthcare. It focuses on creating ‘organisational excellence’, ‘design thinking led innovation’ and ‘strategic continuous improvement’ for start-ups and mid-sized expanding businesses. Further, it aims to recommend ways on how companies can stay healthy and grow despite rapid changes such as regulatory or poor economy undermining them.

Over the past 70 odd years, the pharma industry globally, has evolved grossly and developed processes to ensure that patients receive high-quality products. Yet, we have witnessed a rising number of 483s issued to pharma companies by the US FDA. Severe adverse effects and even deaths reported with drug products undergoing clinical studies or at times after commercialisation, is extremely alarming! This is more so when drug-delivery platforms and their pharmaco-dynamics get more complex. Now more than ever before, there is a dire need to overhaul ‘pharma business operation processes’.

Another quandary is to shift mindsets across this industry that has focused predominantly on compliance, rather than on truly knowing the root causes (and effects) of

DR SHRUTI U BHAT Director Strategic Innovations, Continuous improvement and Training,Shifting Paradigms BC Canada

quality/ business process issues.

Very often, we notice failures easily tagged to individuals, rather than being objectively investigated and/or tracked to process or systems issues. Clearly, something more is needed, but, what?

In my view, pharma industry executives should ask themselves some key questions, such as: ◗ Does my company have at least one process that is world-class? ◗ What would 10X better performance look like in a process that is part of my business operations today? ◗ Which fundamental design choice do I need to set right? ◗ What can pharma companies learn from other industries? ◗ Is my organisation connected to the best-in-class management thinkers and operations experts?

Because, operational excellence is a hard-won skill and a primer for creating ‘organisational excellence’.

A logical question is how do we

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cover ) achieve this operational excellence?

A standard response I often hear is- “By everyone doing their best” … that, by the way is a wrong answer!

Just doing your best won’t work. In fact, we should be thankful that not everybody is doing his or her best. Imagine the chaos it could create at your work site, everyone bumping into each other trying to be ‘best’ and working with cross-purposes.

The correct answer is that you have got to know what to do, then do your best.

Everybody works together with a common goal about how to achieve it. Not just with what seems to be brilliant ideas, but, with a robust ‘process improvement technique’ targeted to create the desired operational excellence and acknowledging that, it is

Every race begins with a small step ‘people’ that create this value.

When people become fully engaged in the process improvement campaign, understand ‘the why’ behind ‘the how’; they become empowered to act independently and to take initiatives. One successful improvement followed by another and then yet another, unleashes an enthusiastic commitment and continuous flow to the ‘operational excellence’ wave.

For starters, a helpful

checklist with following questions can facilitate to understand processes: ◗ How does our company’s value stream (map) look like? ◗ How do we manage innovations? ◗ How does our company reduce waste? ◗ How do we do our jobs? ◗ How is our (business) process undertaken?

As obvious as these questions seem, it is amazing to see, how many companies

forge ahead without answers!

Secondly, one needs to have the existing business operation landscape, the vision of what the business ought to be and the methodology to get there and make it happen!

Like any other transformation, you need to create the core team and its leader.

Then, initiate an intensive training programme or ‘boot camp’ to rapidly build the team’s capabilities. Once this preparation phase is completed, use the five-step approach of define, measure, analyse, improve, control (DMAIC) to get the most from your company’s value chain.

The ‘define’ stage of process improvement, usually germinates from one or more of following four streams – ◗ Innovation in products and services ◗ Innovation in the process

that creates products and services ◗ Improvement of existing products and services ◗ Improvement of the existing (business) processes A point to remember is that, despite the strict vigil for compliance, no pharma manufacturer has succeeded in claiming the industry equivalent of Toyota’s ‘quality crown’. I hope that the global pharma industry can indeed shift its paradigm to achieve a performance that is close to flawless.

There are over 25 different time-tested process improvement methodologies that pharma/ medical devices and healthcare organisations can choose from, in order to achieve increased efficiency with their business operations and derive exponential profits.

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Drug metabolism - Metabolite identification using advance LC-MS/MS system Dr Vijayabhasker V, Principal Scientist, GVK Bio, Hyderabad, Dr Pratima Srivastava, Associate Director, Biology, GVK Bio, Hyderabad, Dr Anoop Kumar, Application Support Manager, Sciex India and Dr Manoj Pillai, Director, Application Support, Sciex India talk about the significance of metabolite identification in drug discovery

M

etabolites are the end products of all chemical or biochemical processes within the system. Metabolism is the process of elimination of foreign and undesirable compounds (xenobiotics) from the body. Metabolites identification is the observation, identification and quantitation of these metabolites on a system basis.

Metabolism Even though metabolism happens in various body organs such as heart, lung, kidney and intestine; nevertheless liver is the major site of metabolism in the body.

Hence, more focus has been levied on liver metabolism.

Metabolism in liver occurs in two phases: Phase-I and Phase-II. Phase I metabolism can be termed as functionalisation reaction. Here, a new functional group (hydroxyl) will be added to the test entity or an existing functional group (demethylation) will be exposed. Phase-I reactions convert a drug to a more polar active/inactive metabolite.

Phase-II metabolism can be termed as conjugation reaction. These reactions (Phase-II), increases the water solubility of a drug by adding up a polar moiety (Glucuronate, Sulfate, acetate). Phase-II reactions convert a parent drug/phase-I metabolite to a more polar active/inactive metabolites by conjugation of subgroups (-OH, -SH, -NH2). Drugs metabolised by phase-II reactions are excreted renally.

40 EXPRESS PHARMA May 16-31, 2016

Liver preparations Various liver preparations exists such as microsomes, S9 fractions, cytosolic fractions and hepatocytes. ◗ Microsomes are easy to prepare and can be stored for longer periods at -80oC. These fractions have enriched P450, FMO and UGT’s. Microsomes are majorly used to study phase-I metabolism reactions and few phase-II metabolism reactions such as glucuronidation. ◗ S9 fractions are same as microsomes, but also contain cytosolic enzymes (SULT, GST, XO, ADHs, and NATs). P450 activity is ~5 fold lesser in S9 fractions than microsomes.

Compounds that are seen to be metabolising fast in microsomes, might actually metabolise slower in S9 fractions, if major route of metabolism is by phase-I reaction. ◗ Cytosolic fractions are used to study few phase-II metabolism reactions such as sulfonation, glutathione conjugation and acetylation.

Hepatocytes are the gold standard for drug metabolism studies. These contain all the enzymes/transporters and cofactors responsible for drug metabolism. Even though, it is a costly affair to use these preparations, nevertheless the information obtained is unmatched.

Figure 1: Comparisons of various parameters that are critical in mass spectrometer selection

as soft spot identification.

However, it is not always true to block or modify the sites, as there exist active metabolites.

Metabolites identification helps in identifying the major metabolite based on abundance and also the biotransformation pathway. In vitro metabolite profiling across species provides information on extent of metabolism and also the selection of right species for toxicity studies.

mass spectrometer is based on m/z ratio. MS/MS provides distinctive fragment patterns which in turn help in providing the structural information. Given the superb speed, sensitivity, and selectivity, MS has become the method of choice for metabolism and metabolite identification studies in drug discovery and development.

Mass spectrometer

QTRAP combines the capabilities of a triple quadrupole mass spectrometer and ion trap technology on a single platform. These systems possess tandem in time (QTRAP)

Metabolite identification Metabolite identification provides information on the site that needs to be blocked or modified in order to improve metabolic properties of the molecule. This is also termed

Mass spectrometer (MS) has emerged as an ideal technique for the identification of almost all structurally diverse metabolites. Detection in

SCIEX Hybrid QTRAP System

and tandem in space functionalities (QQQ). The sensitive and selective performance of an ion trap and the performance of a triple quad in single platform.

QTRAP Systems enable the unique capabilities provided by this technology by coupling targeted triple quadrupole experiments, such as MRM, precursor ion, and neutral loss scans, with high sensitivity ion trap scan functions, such as enhanced MS (EMS), enhanced product ion (EPI), enhanced resolution (ER), enhanced multiple charge (EMC) and MS/MS/MS (MS3) scan. Having a variety of new scan

types and the possibility to combine them in single LC runs enable completely new workflows for many LC/MS/MS applications, including sensitive bioanalytical quantitation, pharmacokinetics studies and metabolite identification/quantification.

The Enhanced Product Ion scan of QTRAP Systems has several advantages over product ion scanning of triple quadrupole mass spectrometers, including: ◗ Much higher sensitivity of Enhanced Product Ion (EPI) spectra because of ion accumulation in the linear ion trap (LIT). ◗ More product ion information in a single MS/MS spectrum because of Collision Energy Spread. ◗ Lower cycle time due to faster scanning of linear ion trap (20000 da/sec) ◗ No inherent low mass cut-off due to fragment generation in the collision cell rather than in the ion trap ◗ Remarkable immunity of LIT from space charge effects which result in mass shift and incorrect isotopic pattern in the spectrum.

Hybrid Triple Quadrupole Linear Ion Trap (QTRAP)

Systems provide a novel workflow for the screening and identification of a multitude of targeted analytes by combining selective MRM detection with a highly sensitive MS/MS scan using Q3 as Linear Ion Trap. In Information Dependent Acquisition (IDA) experiments, the detection of an MRM signal above a specified threshold automatically triggers an Enhanced Product Ion (EPI) scan. These EPI spectra are as sensitive and selective as MRM signals and contain the complete molecular fingerprint because of precursor ion selection in Q1, product ion generation in the collision cell, and ion accumulation in the LIT. The information saved into a full scan MS/MS spectrum allows identification with a higher degree of confidence minimising the risk of potential false positive and negative detection. In addition, the improved cycle time for all confirmatory MRM transitions can be used to increase the dwell time of all other MRM transitions to improve S/N, resulting in better reproducibility and accuracy.

Following are different Information dependent acquisi-

tion (IDA) workflows in QTRAP system for Metabolite Identification and Quantitation experiments: 1. EMS – ER – EPI – MS3 (LIT scan experiments): Best for screening applications in metabolites/impurities identification (Non-targeted analysis approach) 2. NL-ER-EPI-MS3 (QqQ and LIT scan): Screening for structural analogues and GSH conjugate analysis (Targeted analysis approach) 3. PI –ER-EPI or PI-EREPI (QqQ and LIT scan): Screening for structural analogues and GSH conjugate analysis (Targeted analysis approach) 4.

MRM-ER-EPI or pMRM-ER-EPI (QqQ and LIT scan): Target analysis and confirmatory analysis (can be used for Quantitative and Qualitative analysis)

Work flow for metabolite identification studies ◗ Incubation of test entity with various liver preparations, such as microsomes, S9 fractions and hepatocytes. Compound concentration has to be optimised to provide relevant information of the metabolites that even form at relatively low

abundance. Ideally compounds can be incubated at 10 μM concentration. ◗ Protein precipitation has to be used as sample preparation technique. Protein precipitation even though a crude extraction technique, helps in extraction of all the putative metabolites. This is subject to solubility of parent drug in extraction solvent. Ideally, acetonitrile and methanol are the choice of extraction solvents for protein precipitation. ◗ Supernatants from the centrifuged samples can be injected directly in to mass spectrometer.

Alternatively, supernatants can be diluted 1:1 with water and used for analysis. Supernatants can also be concentrated by evaporation under nitrogen gas. ◗ Samples have to be initially analysed with acquisition method built with the assistance of IDA method wizard (IDA wizard is a specific software feature available in analyst software). IDA wizard helps in combining full scan (EMS, EMC, MRM and NL) functions and dependent scan functions (EPI). Full scan functions help in identifying the parent ion in case of EMS, EMC scan function, parent ion-

fragment ion reaction in case of MRM and NL scan functions.

Parent ions/parent-fragment ion reaction detected in full scan function will further trigger the EPI scan function. EPI scan function will provide the complete fragment information of all these full scan masses. ◗ Metabolites have very similar fragmentation pattern to that of parent drug. However, there exist few fragments that are different from the parent drug.

These unique fragment ions will help in proposing the soft spots for metabolites. In this case, soft-spot has to be proposed for di-demethylated metabolite of verapamil. Few fragments such as 165.10 and 150.10 are common in between the parent drug and metabolite. However a unique fragment ion (275.10) that is seen in metabolite does not exist with the parent drug. This fragment ion is a di-demethylated fragment ion of the fragment ion (303.20) seen in parent. This helped in proposing the di-demethylation reaction to a particular portion of the structure. Typically, this is the procedure followed in identifying and proposing the soft-spots for putative metabolites.

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EXPRESS PHARMA

41

May 16-31, 2016

RESEARCH RSEARCH UPDATES

Bacteria blocks mosquitoes from transmitting Zika: Brazilian study The method involves inserting the bacteria into mosquito eggs, which then pass the bacteria along to their offspring

I

nfecting mosquitoes with a strain of bacteria known as Wolbachia significantly reduced their ability to transmit the Zika virus, Brazilian researchers said, raising hope for this biological method of blocking transmission of the deadly virus.

The bacteria has been released in several countries including Australia, Brazil, Indonesia and Vietnam as part of strategies to control dengue, and the new finding shows the method also works with Zika, a close relative of dengue. Zika has been linked with the birth defect microcephaly that has been sweeping through South and Central America and the Caribbean and making its way north to the US. In February the World Health Organisation declared

Zika a global health emergency. The connection between Zika and microcephaly came to light last fall in Brazil, which has now confirmed more than 1,100 cases of microcephaly that it considers to be related to Zika infections in the mothers.

The new study, by researchers at Brazil's Oswaldo Cruz Foundation and published in Cell Host & Microbe, takes advantage of the naturally occurring strain of bacteria known as Wolbachia, which live in insect cells and are found in 60 per cent of common insects. The method involves inserting the bacteria into mosquito eggs, which then pass the bacteria along to their offspring. "The idea has been to release Aedes mosquitoes with Wolbachia over a period of a few months,

so they mate with Aedes mosquitoes and over time, replace the mosquito population," said senior author Luciano Moreira of the Oswaldo Cruz Foundation in Rio de Janerio, which is preparing to host the Olympics this summer.

Moreira is part of Eliminate Dengue, a non-profit that is testing the approach in 40 locations around the world. In the Zika study, the team infected field mosquitoes and Wolbachia-infected mosquitoes with two strains of Zika currently circulating in Brazil.

After two weeks, mosquitoes carrying Wolbachia had fewer particles of the virus in their bodies and saliva making them less able to infect humans with the virus.

"Wolbachia showed to be as effective on Zika as the most important dengue experiments we did," Moreira said. Dr Jason Rasgon, an entomologist at Penn State University, said in some prior experiments Wolbachia has been shown to suppress transmission of one pathogen but enhance transmission of another. The new finding removes that concern. Moreira cautioned that the strategy is not 100 per cent effective and will not eliminate the virus, saying it should be used as part of an integrated control strategy.

Reuters

Regeneron pain drug clears late-stage trial Fasinumab binds to nerve growth factor (NGF) proteins and block their activity, reducing pain DRUGMAKER Regeneron Pharmaceuticals said its experimental drug to treat moderateto-severe osteoarthritis pain was successful in a late-stage study. The drug, fasinumab, was tested on 421 patients with a history of inadequate pain relief or intolerance to current pain killers. After 16 weeks, patients given fasinumab reported less pain, as measured on a physician-grade scale, than those

42 EXPRESS PHARMA May 16-31, 2016

Current treatments for pain management include non-steroidal anti-inflammatory drugs, antiseizure agents, and opiates given a placebo, Regeneron said in a statement.

Current treatments for pain management include nonsteroidal anti-inflammatory

drugs, anti-seizure agents, and opiates. However, these drugs cause multiple side-effects and often prove to be toxic with long-term use. Fasinumab binds

to nerve growth factor (NGF) proteins and block their activity, reducing pain. A number of companies, including Pfizer and Eli Lilly & Co, are developing

drugs that target NGFs. The US Food and Drug Administration placed fasinumab and other experimental agents targeting NGF on partial clinical hold in December 2012 after reports that animals treated with these drugs had nerve damage.

Fasinumab is no longer on clinical hold, according to Regeneron's website.

Reuters

Laser brain cancer treatment may bring extra advantage The study using lasers to treat people with brain cancer is now in a so-called Phase II clinical trial NEUROSURGEONS using lasers to treat brain cancer have discovered that the technique breaks down the bloodbrain barrier, a finding that could lead to new treatment options for patients with the deadly disease. The blood-

apy," said Dr Eric Leuthardt, a professor of neurosurgery at Washington University in St. Louis. "So not only are you killing the tumor, you are actually opening up a window of opportunity to deliver various drugs and chemicals and ther-

brain barrier is sort of a natural "security system" that shields the brain from toxins in the blood but also blocks potentially helpful drugs such as chemotherapy.

"We were able to show that this blood-brain barrier is broken down for about four weeks after you do this laser ther-

apies that could otherwise not get there," Leuthardt added.

The study using lasers to treat people with brain cancer is now in a so-called Phase II clinical trial in which a treatment is given to a larger group of people than the initial phase to see if it is effective and to further evaluate its safety. The

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laser technology, approved by the US Food and Drug Administration in 2009 as a surgical tool to treat brain tumors, involves a small laser-tipped probe that heats up and kills tumors from the inside out. As part of the trial, patients after the laser therapy are given the powerful chemotherapy drug doxorubicin, known as one of the least likely to penetrate the blood-brain barrier.

"Kind of makes you smile when they say you are a good candidate for something new," said Kathy Smith, a participant in the clinical trial who has been battling cancer since 2009. Initially diagnosed with ovarian cancer, Smith is now being treated for recurrent glioblastoma, one of the most difficult forms of brain cancer to treat. Most patients diagnosed with these types of brain tumors survive just 15 months, according to the American Cancer Society.

The trial is still ongoing but Leuthardt called the initial results promising. "What's interesting is that the blood-brain barrier is a two-way street," Leuthardt said. "By breaking it down, you can get things into the brain, but also by breaking it down now things can go from your brain out into your circulation, to your peripheral system, which includes your immune system."

Leuthardt said he is using drugs to "amplify the immune system to fight the cancer" in combination with laser therapy. The researchers hope to publish their findings later this year.

Reuters

More evidence links heartburn drugs to serious kidney problems These drugs are generally viewed as safe and may be overprescribed PEOPLE TAKING common heartburn medications known as proton pump inhibitors (PPIs) are at increased risk of new and severe kidney disease, according to a US study. Among hundreds of thousands of patients in Department of Veterans Affairs (VA) databases, new users of PPIs without kidney disease were 30 per cent more likely to develop chronic kidney disease over the course of five years.

Their risk of kidney failure was doubled. PPIs like Nexium and Prevacid are prescribed to treat ulcers, heartburn and acid reflux and are some of the most effective forms of treatment available, the study authors write in the Journal of the American Society of Nephrology.

These drugs are generally viewed as safe and may be overprescribed and continued for long periods without being necessary, they note. “We suggest judicious use of PPI, and that use be limited to when it is medically necessary and to the shortest duration possible,” said senior author Dr Ziyad Al-Aly, associate chief of staff for research and education at the VA Saint Louis Health Care System.

The study team analysed data in national VA databases on 20,270 people who had recently started taking PPIs. They compared this group to 173,321 people who had started taking H2 blockers, a group of drugs that reduce stomach acid by a different mechanism, blocking histamines in the stomach. All patients were free of kidney problems at the start, and were followed for five years to see if their kidney function changed.

After adjusting for personal, social and economic factors as well as health conditions that could influence kidney disease risk, the study team found that people taking PPIs were at significantly higher risk of new kidney

problems compared to those taking H2 blockers.

The risk of a decline in kidney function was 32 per cent higher for people taking PPIs and the risk of new cases of chronic kidney disease was 28 per cent higher. Patients taking PPIs were 96 per cent more likely to experience end-stage renal disease - kidney failure than those who took H2 blockers.

The risks also increased with the time that someone was taking PPIs, leveling off after about two years of use. Because many PPIs are available over the counter, people may take them without the input of a doctor, AlAly said. He recommends limiting the use of over the counter PPIs to only times when it is necessary. “If people find themselves taking over the counter PPI frequently, then a doctor consultation is definitely needed to determine best and safest options available to that patient,” Al-Aly said.

H2 blockers are much less likely to cause kidney problems but often aren't as effective as PPIs, said Dr David Juurlink, a clinical pharmacologist and drug safety researcher at the University of Toronto, said.

“For many patients, dietary modification (less fat and alcohol) would make acid-lowering drugs unnecessary and would impart other long-term benefits as well,” said Juurlink, who was not involved in the study. “Patients should appreciate that, like all drugs, PPIs carry risk. The fact that they're available over the counter doesn't mean they're safe,” Juurlink said. “People who take PPIs and are later found to have kidney problems should ask their physicians whether the drugs might be playing a role,” he advised.

Reuters Health

EXPRESS PHARMA

43

May 16-31, 2016

RESEARCH

Weight loss may limit diabetes-related brain changes The brain consumes about 20 per cent of the energy the body uses, and the main source of that energy is blood sugar LOSING WEIGHT may help people with diabetes limit damaging changes to the brain that can result from the disease, a US study suggests. Researchers followed a group of diabetics for more than a decade, offering 164 of them intensive counseling with diet and exercise support designed to help them shed at least 7 per cent of their weight and keep it off. Another 155 diabetics received only a standard disease education program.

The counseling group lost more weight and achieved greater gains in cardiorespiratory fitness than their peers in the control group. And, in a sign that weight loss might protect against diabetes-related brain damage, the control group had smaller volumes of gray matter and more white matter disease by the end of the study. Smaller volumes of brain tissue and the presence of white matter disease are linked to cognitive decline.

“If individuals with diabetes change their behavior in mid-life to lose weight and increase physical activity, this can lead to longterm benefits in brain health later in life,” said lead study author Mark Espeland, a public health researcher at Wake Forest School of Medicine in Win-

ston-Salem, North Carolina.

Globally, about one in nine adults have diabetes, and the disease will be the seventh leading cause of death by 2030, according to the World Health Organization.

Most of these people have type 2, or adult-onset, diabetes. Their bodies can't properly use or make enough of the hormone insulin to convert blood sugar into energy.

The brain consumes about 20 per cent of the energy the body uses, and the main source of that energy is blood sugar, Es-

peland said. Diabetes makes blood sugar a less reliable energy source, which can compromise brain function and lead to cognitive decline over time. To see if intensive lifestyle changes might counter the effect of diabetes on the brain, Espeland and colleagues offered one group of study participants intensive counseling, encouraged calorierestricted diets with limited amounts of fats and proteins and set exercise goals of at least 175 minutes a week of moderate activity, which amounts to brisk

walking.

The counseling group participants initially had weekly sessions, followed by monthly meetings for an extended period of time. By contrast, the other group receiving just standard care was invited to attend group classes a few times a year. Over the first year, the intensive counseling group lost about 12 per cent of their weight on average, compared with less than 1 per cent in the control group. Cardiorespiratory fitness, or the ability to supply oxygen to the muscles during exercise, improved about 26 per cent for the counseling group over the first year, compared with 7 per cent for the others. While the counseling group gave back some of these initial gains over the course of the 10-year study, they still did better than the other diabetics over the long run. Total brain volume was similar between the two groups. But the average volume of so-called white matter hyperintensities – concentrations of white matter that represent damaged areas, which can happen with age and be worsened by diabetes – was 28 per cent lower for the counseling group than the other participants. Another sign of dete-

rioration, the average volume of fluid-filled cavities called ventricles, was 9 per cent lower for the counseling group than for the others. Overall, both groups had similar cognitive function at the end of the study, although the counseling group performed better on tests of attention and processing speed.

One limitation is that researchers didn’t look at other factors that might lead to better diabetes control and potentially protect the brain, such as blood pressure, sleep apnea, depression, medication use and inflammation, the authors note in the journal Diabetes Care. Still, weight loss and other lifestyle changes reduce high glucose levels that are toxic to the brain, Dr Caterina Rosano, a researcher at the University of Pittsburgh who wasn’t involved in the study, said.

“The results from this and other studies suggest that a healthy lifestyle with appropriate diet, exercise and cognitive stimulation may help preserve brain function and structure in diabetics over pharmacological treatment alone,” Dr Joe Verghese, director of the MontefioreEinstein Center for the Aging Brain said.

Reuters Health

US approves first drug for psychosis linked to Parkinson's Nearly 40 per cent of all Parkinson's disease patients experience psychosis, characterised by hallucinations and delusions ACADIA Pharmaceuticals' drug for psychosis linked to Parkinson's disease was approved in the US, becoming the first treatment for the condition to get a nod in the country.

The US Food and Drug Administration, however, asked Acadia to include a black-box warning, its strictest warning, on the drug's label for an increased risk of death associated with its use in older people.

An estimated 50,000 Amer-

44 EXPRESS PHARMA May 16-31, 2016

icans are diagnosed with Parkinson's disease each year and about 1 million Americans have the condition, the FDA said in a statement, citing data from the National Institutes of Health. The drug, Nuplazid, is expected to be priced at $13,500 per patient for a year and reach more that $1 billion in sales in 2021, according to Leerink analyst Paul Matteis.

Analysts have said the black-box warning will have

limited impact on the sales of Nuplazid as antipsychotics often come with such warnings.

So far, the condition was treated with off-label antipsyhotic drugs including quetiapine, clozapine, risperidone and olanzapine. The drugs, which target the overproduction of a chemical called dopamine, are less effective and come with side effects including depression, agitation and anxiety. Nuplazid is considered safer, ac-

cording to analysts, as the drug does not affect dopamine production, instead targeting the 5HT2A receptor, which is linked with neuropsychiatric disturbances.

Nearly 40 per cent of all Parkinson's disease patients experience psychosis, characterised by hallucinations and delusions. Matteis also said he was optimistic that the drug would soon be covered by private and government insurers.

Although Nuplazid could be one of the most expensive antipsychotics on the market, "insurers are less likely to ask patients to try cheaper off-label alternatives given their safety risks," he said ahead of the approval. In March, an advisory panel to the FDA had backed Nuplazid, but had said the drug's efficacy was not as robust as it would have liked.

Reuters

PHARMA ALLY VENDOR NEWS

Ion Exchange expands Bahrain business to meet growing demand in Gulf market Launches chemical blending facility to serve as export hub for GCC region

I

on Exchange, environment solutions provider has announced the launch of a new chemical blending facility in Bahrain. The company is expanding its facility in Bahrain in order to improve the products and services it offers the wider GCC region, a market currently worth around $1.5 trillion.

Reportedly, the new facility will serve as the chemical export hub for the GCC region and North Arab states, creating around 30 jobs over the course of the next three years. The Bahrain Economic Development Board (EDB), which provides advice and practical help to companies establishing operations in Bahrain, assisted Ion Exchange with company set up and other business requirements in order to ensure the company’s successful inception.

Commenting on the announcement, Rajesh Sharma, Chairman and Managing Director of Ion Exchange said, “Ion Exchange has successfully executed globally tendered projects and exported plants to the Middle East, Africa and South East Asia, to the

46 EXPRESS PHARMA May 16-31, 2016

L-R: JP Pathare, Sr VP - International Division, Rajesh Sharma, CMD of Ion Exchange and Husain Rajab, Director of Manufacturing, Transport and Logistic, Bahrain EDB

stringent requirements of customers, consultants and EPC contractors. It has made it presence felt in Europe and the US with export of resins and water treatment chemicals. The launch of the new Bahrain facility is part of our wider strategy to ensure proximity to our GCC and North Arab market.

Bahrain is located at the heart of the Gulf market with excellent transport and logistics connections throughout the region. We are expanding to meet the GCC’s rising demand for water treatment products and services and are excited to work closely with organisations like the Bahrain Economic Development Board

to ensure our success.”

The company’s total water management solutions span the entire water cycle – drinking water purification, pre-treatment, process water, waste water/sewage treatment and recycle with point-of-use, packaged, pre-engineered and custom-built plants; a wide

range of drinking water purifiers and water conditioners for the household and institutional segments. The company also manufactures ion exchange and speciality resins, membranes, polyelectrolytes, boiler/cooling water and fireside chemicals and process chemicals for sugar and paper production. Ion Exchange also offers technologies in liquid waste treatment, solid waste management and wasteto-energy thus providing a complete portfolio of advanced environmental solutions.

Reportedly, it has more than 1,00,000 plants worldwide including over 1,000 major installations at core sectors such as thermal & nuclear, fertiliser and refineries, as well as chemical, automobile, electronics, paper, food & beverage, pharma and textile industries.

Ion Exchange has units spread across India and in UAE. The UAE plant manufactures reverse osmosis as well as packaged sewage treatment plants and serves as a manufacturing hub for export to countries in the Middle East and North Africa.

EP News Bureau - Mumbai

Pharma tech firms Werum ITSolutions and Zenith Technologies announce global MES partnership The partnership makes Zenith Technologies an Endorsed Service Partner of Werum IT Solutions in both the US and Europe ZENITH TECHNOLOGIES and Werum IT Solutions have formed a global partnership to support pharma companies with the implementation of manufacturing execution system (MES) technology to improve production performance.

The collaboration brings together Werum IT Solution’s MES PAS-X software, which is designed to increase efficiency, improve productivity and meet regulatory requirements during pharma manufacturing, with Zenith Technologies’ ability to integrate systems and provide on-theground automation technical support. The PAS-X software is used by the majority of the world’s top 30 pharma and biotech companies but also by many regional and mid-sized

Brendan O’Regan, Chairman and Founder, Zenith Technologies; Torsten Isenberg, Senior Director Services, Werum IT Solutions; Karl Hoffmann, Senior Director Marketing & Business Development, Werum IT Solutions and Hans-Peter Subel, CTO, Werum IT Solutions, signing the agreement at Werum’s headquarters in Lüneburg, Germany

manufacturers.

The partnership, which was signed at Werum’s head-

quarters in Lüneburg, Germany, makes Zenith Technologies an Endorsed Service

Partner of Werum IT Solutions in both the US and Europe. Zenith Technologies will support Werum customers during all MES implementation phases, delivering comprehensive support and consultancy services that complement Werum’s manufacturing IT solutions.

“We are delighted to partner with Zenith Technologies,” says Torsten Isenberg, Senior Director Services at Werum IT Solutions. “As an Endorsed Service Partner, Zenith Technologies has the knowledge and experience required to be part of our PASX service partner program.

Our main objective is to ensure a high level of support for our customers through reliable, experienced and certified partners.”

Brendan O’ Regan, Chairman and Founder, Zenith Technologies, adds, “Given our combined expertise in automation and the similarities in our customer base, the collaboration represents a strategic move for both companies.

By combining Werum’s MES technology with our technical implementation experience, we can provide customers with a high quality of service, training and local level support, helping them to remain both compliant and competitive. We are continually investing in training and working together with Werum and other solution providers to ensure we stay ahead with the latest technology.”

EP News Bureau - Mumbai

BÜCHI LabortechnikAG acquires flash chromatography and ELSD product lines from Grace The lines become part of BUCHI’s broad chromatography portfolio and BUCHI will provide complete service, support, and preventative maintenance services BÜCHI LABORTECHNIK AG (BUCHI), a leading global provider of laboratory technology solutions for R&D, quality control, and production equipment, has acquired from W R Grace & Co (Grace) its high performance REVELERIS Flash Chromatography Systems, GraceResolv. The lines become part of BUCHI’s broad chromatography portfolio and BUCHI will provide complete service, support, and preventa-

tive maintenance services.

Grace will continue to supply the purification media used in the REVELERIS product line. In addition, Grace will continue to provide Davisil and Vydac purification media to the industry. The acquired portfolio of purification products includes the REVELERIS Prep Purification System, which performs both flash chromatography and preparative LC on a single system; the

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REVELERIS X2 Flash Chromatography System, the first flash technology with integrated ELS, UV, and UV-Vis detection; and a broad range of high-loading, high-efficiency flash cartridges, which offer the purification chemists maximum purity and recovery of target molecules in minimal time. The systems are used in a variety of industries including pharmaceuticals, biotech, food and beverage, natural prod-

ucts, carbohydrates, nutraceuticals, peptides, and proteins.

Thomas Liner, Chief Executive Officer, BUCHI Group, said, “This opportunity is perfectly aligned with our strategy to invest in preparative chromatography and complete our portfolio of solutions for drug discovery and development. This makes life simpler for our customers and greatly expands our offerings in this important and growing

segment. We are delighted that BUCHI will continue to develop these product lines and support our many customers. The business is a natural fit for BUCHI and it’s clear we share a commitment to quality and customer service that will be greatly appreciated by the technicians and business leaders who have come to rely on these technologies.”

EP News Bureau - Mumbai

EXPRESS PHARMA

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May 16-31, 2016

PHARMA ALLY PRODUCTS

Merck launches three Mobius products for bio-pharma industry MERCK, leading science and technology company, is launching three Mobius products that deliver improved efficiency and ease-of-use for biopharma manufacturing workflows.

The new Mobius products include a 1000-litre single-use bioreactor with an industryleading design, a 2000-litre mixing system for difficult-tomix biopharm ingredients and a large volume liquid transport system for aseptic and nonaseptic substances.

“Our newest Mobius products meet our customers’ increasingly complex demands for user friendly systems that allow them to focus on their science,” said Udit Batra, CEO, Life Science at Merck.

The Mobius 1000 litre single-use bioreactor completes the comprehensive Mobius stirred tank portfolio of 3 to

2000 litre sizes, delivering greater flexibility and continuity for scale-up. With the industry’s only bottom-loading drawer for easy and safe bag installation, Merck’s new bioreactor is designed to achieve homogenous and fast mixing for consistent performance, especially at large scale.

The Mobius Power MIX 2000 creates a strong vortex to handle difficult-to-mix buffers, media and other biopharm ingredients. Powerful mixing is achieved from an impeller design and motor based on magnetically-coupled NovAseptic technology, a proven mixing technology in stainless steel tanks. The Power MIX 2000 provides accessible, sterile zero deadleg sampling directly from the mixing container. A Probe Port allows insertion of either a reusable

standard probe for non-aseptic processes or a pre-sterilised, single-use sensor for in-process pH measurement of aseptic processes.

The Mobius single-use 3D large liquid transportation system’s single-use bags and stainless steel transporter bins facilitate the safe and convenient road transport of aseptic and non-aseptic media, buffers, in-process intermediates and final bulk drug products at cold or ambient temperatures. The system offers four single-use bag assemblies with working volumes of 100 to 500 litres. All bags are constructed from PureFlex Plus film with a proven low extractable profile and gas barrier properties.

Contact Karen Tiano Tel: +1 978 495 0093

TAKE Solutions’product pharmaREADY th achieves 100 customer win TAKE SOLUTIONS announced that it has achieved its landmark 100th customer win for pharmaREADY, its fully integrated, regulatory compliant, web-based product suite.

This flagship product suite was launched in the market in 2005, evolving over the years through 10 major update releases, and now caters to 100 global customers across North America, Europe, Middle East, Australia, China & India. pharmaREADY clients include

48 EXPRESS PHARMA May 16-31, 2016

Microlabs, Aurobindo Pharma, Piramal Enterprise, Intas Pharma, Macleods Pharma and Manipal College of Pharmaceutical Sciences (MCOPS). pharmaREADY is a cloud or on premise regulatory suite comprised of Document Management, Training Records Management, Structured Product Labelling and Electronic Common Technical Document (eCTD) Publishing Solutions.

Reportedly, the solution simplifies the complex

process of creating, viewing, and managing drug approval submissions to Health Authorities like US-FDA, Health Canada, European Medicines Authority, Swiss Medic, Saudi FDA, Australia and South Africa.

Ram Yeleswarapu, President & CEO, TAKE Solutions said, “We are extremely proud to mark this important milestone of 100 successful deployments. The key to pharmaREADY’s success since its

launch over a decade ago is its intuitive and easy to use workability. We continue to make significant strides towards achieving our vision of improving outcomes with pharmaREADY, with 97 per cent customer retention since 2015. Backed by this momentum, we look forward to scripting more success stories with our product in the future. ’’ In a recently conducted customer satisfaction survey, TAKE reported that all its

customers expressed immense satisfaction with the 24*7 customer support provided and most expressed willingness to refer PharmaReady to others, enabling successful cross selling.

Contact Samhita Suresh TAKE Solutions Website: samhita.suresh@takesolutions.com Tel: +91 44 2435 7359/60

PHARMA ALLY PRODUCTS

AVTto introduce automation and quality solutions for packaging and label markets at Drupa 2016 AVT, A LEADER in print inspection, print process control, and quality assurance, intends to introduce an extensive roster of new solutions at Drupa, May 31-June 10 in Düsseldorf, Germany.

Located at Hall 9, Stand C60, and with more than 15 systems across its partners’ stands, AVT enters the show as the world’s top automatic inspections solutions provider in the global labeling and packaging industries; currently, approximately 50 per cent of all high-end inspection and quality assurance systems in these two sectors are AVT platforms. At Drupa, AVT will introduce a set of next-generation solutions and technologies, including a new cloud-based quality standards and automation platform; digital press inspection and control solutions; inline color management solutions; and several new inspection platforms for web and sheet-fed packaging applications.

New cloud-based quality and automation platform AVT will also exhibit its new iCenter Platform, a cloudbased solution for quality control automation and production performance insights.

With the iCenter platform, printers can now offer brand owners around the globe consistent product quality as well as production reports showcasing these heightened quality standards.

The iCenter platform provides solutions to set crosssite quality standards, auto-analyse PDF files for inspection, and extract business intelligence from the production floor with a seamless connectivity to MIS and prepress solutions for optimised automated workflows. The platform’s cloud-based nature

empowers printers to manage and control quality and production standards for facilities around the world, ensuring cross-site consistency for both quality and colour.

Drupa also represents an opportunity for AVT to showcase proven solutions for workflow automation. AVT offers a broad range of solutions for setting quality standards and auto initiation, such as ProMIS and Zero Setup.

Moreover, AVT’s complete Workflow Link solution increases line efficiency and productivity, stopping only for designated defects. Slitter rewinders can run at top speeds and, by selecting the extraction of only critical defects, rewinder stops can be reduced by up to 50 per cent for vastly improved productivity.

In addition, AVT’s latest version of its well-regarded Offline Setup provides quality standardisation and shortens setup time. The solution standardises inspection results, thereby reducing the “human factor” in the inspection process. The result is reduced waste and streamlined setup workflows, all under the same global quality standards.

To subscribe: bpd.subscription@expressindia.com

Leader in digital inspection and press control AVT also draws distinction as the unrivaled leader in advanced inspection and workflow solutions designed to meet the specific needs of digital printers. The company offers a variety of solutions tailored for short run print jobs and digital workflow: 100 per cent inspection and workflow for HP label and packaging presses, 100 per cent inspection for Label Inkjet presses, and close loop quality engine press control for digital inkjet, as explained below.

AVT also will showcase its close partnerships with many of the digital printing space's most prominent leaders. For example, during Drupa AVT will present four systems on HP Indigo presses. These include the debut of Apollo 30K, which was designed for the HP Indigo 30000 Folding Carton press and features a dedicated end-to-end solution for 100 per cent sheet inspection with various workflows supported, including single pack ejection for optimal quality and automation. Also presented are the Apollo 20K and Helios solutions for the HP Indigo 20000 flexible packaging

press and HP Label press series. These solutions offer 100 per cent inspection with AVT’s ZeroSet setup feature for print and inline finishing.

The new Jet-IQ is the only proven closed loop solution for digital inkjet presses. Installed on digital presses from Heidelberg, Landa and other prominent vendors, Jet-IQ is a quality engine that works in synergy with press controllers to maintain exemplary print quality, offering full connectivity to all steps and solutions of digital printing. Jet-IQ allows digital printers to gain a competitive advantage through enhanced print quality at high speeds, reduced press down time, and full reporting capabilities.

Inline colour measurement solutions AVT will also introduce its SpectraLab II, a new generation of in-line spectral measurement for nearly any application, including transparent flexible, paper, cartons, etc.

SpectraLab II offers new compact design, advanced colour workflow management and improved inline-to-offline measurement correlation.

Based on the proven SpectraLab, with more than 30 packaging and label customers worldwide, and AVT’s Clarios, which is used on over 700 in-line color systems throughout the worldwide offset printing landscape, AVT’s color management prowess offers real-time, in-line spectral measurements like LAB, DeltaE and dot gain.

Web and sheet-fed packaging and label inspection solutions Among the portfolio of AVT systems presented at Drupa are the new Argus Turbo and

Helios Turbo 100 per cent Inspection platforms for label and packaging applications, offering a breakthrough in end to end quality automation and workflow management.

With the new AVT Workflow Link for packaging applications, customers can now control quality downstream from the production process, detecting any defects on press and eliminating them from the rolls at any finishing station.

Also on display will be AVT's leading inspection solutions for sheet-fed applications such as folding cartons, metal packaging and corrugated. For the folding carton segment, AVT will feature a live demonstration of its new Apollo 30K for HP folding carton presses, while for the metal sector the company will present its Titan 100 per cent inspection solution that brings proven results of waste reduction and higher quality standards. For the corrugated market, AVT leverages its strategic alliance with Erhard and Leimer (E+L) who will present a 100 per cent inline inspection solution at its Drupa stand.

Finally, Drupa affords AVT a forum to showcase its myriad partnerships with key market players – alliances that provide its customers a seamless bridge to production automation.

AVT’s quality and process control solutions have been intimately integrated into the presses of many of the world’s most respected labeling and packaging equipment manufacturers.

Contact Christopher Dale Turchette Agency Ph: (973) 227-8080 ext. 116 Website: cdale@turchette.com

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PHARMA ALLY PRODUCT

HMXAmbiator: Aiding Himalaya avert degradation of raw material THE HIMALAYA Drug Company is a leading multinational medicinal drugs company. It produces healthcare products under the name Himalaya Herbal Healthcare. It has grown multifold and is spread across locations in India and abroad. Today, the Himalaya brand is synonymous with safe and efficacious herbal products; their products are prescribed by 400,000 doctors worldwide, and millions of customers trust them for their health and personal care needs.

200 acres. The production block 2, raw material section comprises an area of approximately 13000 sq ft (PB2 RMS) where the herbal/ayurvedic medicine in the form of granules/powder or liquid is stored before taking it into production.

This space was only ventilated and temperatures soared above 35ºC in summer. Generally, when the temperature crosses 30ºC, the raw material turns lumpy which then has to be rejected.

The solution The challenge Himalaya's revamped factory in Bengaluru commenced operation in 2006 and is spread over

This is when the Himalaya management approached to HMX for their IDEC system.

The requirement was that the

temperature in any weather should not cross 30ºC. HMX then carried out a comprehensive heat load study and based on the calculated room sensible heat gain, assumed delta T of 56 Dec (difference between room temperature and grill temperature) it was estimated that

30000CFM of dual stage evaporative cooled air would be adequate for the worst condition to ensure that the space temperature does not cross 30ºC. This was rechecked with the ideal number of air changes and it was found to be in line with industry standards. Himalaya then invited HMX to supply two 15000CFM machines totaling to 30000CFM. Also Himalaya wanted to continue with the existing ducting as it was relatively new and changing the same would obstruct factory working. The HMX team then executed the project keeping the same ducting without any interference in factory working with successful air balancing.

The result HMX Ambiator was commissioned in October 2013. Based on our data monitored, the temperatures have never crossed 28ºC since then. Earlier more than two tons out of a storage capacity of 20 tons base medicines were degraded and rejected which has now been totally eliminated.

In the words of Laxmipathy, Store Manager, “We are extremely satisfied with the performance of HMX units, earlier more than 10 per cent of material used to be rejected in the past due to temperature spikes, now due to control of temperature there is zero rejection.”

Virosil Pharma: A Swiss eco-friendly disinfectant SANOSIL BIOTECH, a Mumbai based company pioneered the novel concept of ecofriendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin. The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with Silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can be used where other chlorine based disinfectants have been feared.

Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, Ranbaxy, J&J, Abbott, Serum Institute, Dr

50 EXPRESS PHARMA May 16-31, 2016

Reddy’s, Lupin, Cadila Healthcare, Wockhardt, Biocon, AstraZeneca, etc., as a very effective fumigant and disinfectant providing an environment with microbial containment and a

completely safe and sterile environment The added benefits of Virosil Pharma is that it does not give any foul odour, irritation to the eyes, requires no

de-fumigation and is very easy to handle. There are also no tears or fears for overdosing. A room of 1000 cubic feet can be ready and completely sterile within a maximum period of 60 minutes using a 20 per cent of solution of Virosil Pharma.

With a recommended MicroMist ULV fogger gives a very fine mist that even penetrates between cracks of surfaces ensuring a safe and sterile environment.

Virosil is also very widely used for disinfection of surfaces, equipments, raw water, pipelines and DM plants. The formulation has been tested in various reputed institutions in Switzerland, France, Germany and Australia.

The company has great respect for human health and the environment. The CEO, Dev Gupta, a MBA from the Bent-

ley Graduate School of Business, Boston, has been actively marketing it under the brand Virosil Pharma, nationally.

“According to Gupta, Virosil Pharma has simplified the lives of so many people who work in the pharma industry as they are guaranteed sterility with the minimum risk exposure from the fumes of Formaldehyde based products” The company also offers a customised disinfection audit on its website; www.sanosilbiotech.com Contact Dev Gupta, CEO Sanosil Biotech Warden House, 1st floor, Sir PM Road, Fort, Mumbai 400 001.

Tel:. 022 22872295, Email: info@sanosilbiotech.com

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Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

es Decad ies. ustr Over d In to ice of serv ing Stronger Grow t & Integrity us with Tr

Pharmaceuticals, Packaging, Chemicals, Food, Beverages, Distilleries, Breweries, Paints, Food, Oils & Consumers

MAJOR PRODUCTS MANUFACTURED AT UNIPACK Linear Vial/Bottle Washing Machines Sizes: vials 2ml to 100 ml & Bottles 15 ml to 500 ml Scramblers/Unscramblers Sizes:24” dia, 36” dia. 48” dia 60” dia Hydraulic Loading Platforms Inspection Tables Loading and unloading Conveyors Liquid Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials Powder Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials

Sterlity Testing Units in S.S. Sizes: Single Place, Three Place & Six Place Plate and Frame Type Filter press in SS Size: 20 cm X 20 cm, 40 cm X 40 cm, 60 cm X 60 cm, 100 cm X 100 cm Zero hold up/Sparkler Filter press Size : 600 LPH to 15500 LPH Sterile Pressure and Storage Vessels Size : 10 ltrs to 500 ltrs Membrabe Filter Holders (Size: 293 mm, 142mm, 90mm) Inline Filter Holders (Size:47mm, 25mm, 13mm) Basket/Bag/Catridges Filters

We Supply different sizes of Filter Sheets and Filter Modules of Major International Brands

Our Achievements: Over 2500 installations of our major products manufactured in-house are supplied to all Leading Companies in India & Multinationals abroad

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EXPRESS PHARMA Group Companies:

KILITCH HEALTHCARE LLP

NBZ

NBZ PHARMA LTD.

Manufacturing Facilities Accrediation: n n n

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Small volume parenterals (Ampoule, Vials) Three Piece Ophthalmic Preservative Free Ophthalmic filling Prefilled Syring

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Ophthalmic Division Export Division

Head Office: Kilitch Healthcare LLP, 902/B Godrej Colesium, Behind Everad Nagar, Near Priyadarshani Cirlce, Sion (East), Mumbai – 400022.

Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957

Factory: NBZ Pharma Ltd. R-905, T.T.C. Indl. Area, M.I.D.C, Rabale, Navi Mumbai - 400 701.

Tel. : 022 2769 9174, 6516 2146 Mr. Krishnakant Yajurvedi : +91 7710040409

www.kilitchhealthcare.com

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SPECIALIZED IN PLATINUM CURED SILICONE TUBES,BRAIDED HOSES & INFLATABLE SEALS/GASKETS 1st Indian Silicone Rubber Product Mfg. Co. certified with Clean Room of Class 10000 For high purity & intricate application of Vaccines & Injectables, most of the Pharma companies are insisting only AMIs Silicone Tubing & Braided Hoses, accredited by US FDA DMF No. 26201 with Extractable & Leachable Studies.

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An ISO 9001:2008/14001:2004/18001:2007 & Clean Room Certified Co. DMF No. 26201 accredited by USFDA

303 & 319, Mahesh Indl. Estate, Opp. Silver Park, Mira-Bhayander Rd., Mira Road (E), Thane - 401104. Maharashtra INDIA. Tel.: +91-22-28555 107/631/91. Fax : +91-22-28555 378. Cell : +91-9223290931 / 43.

Email : info@amipolymer.com website : www.amipolymer.com

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+91 9560055905, +91 9560055904 CORPORATE OFFICE: 23/1, First Floor, East Patel Nagar, New Delhi - 110008, Tel: 011 - 46 275 275, Email: redcarpettours@redcarpettours.net REGIONAL OFFICE: A 34, Flat No. 101, 102, Dataguru, C.H.S. LTD., Sec.- 4, Navi Mumbai - 400705, Tel: 022 - 27751815/16/17, Email: sales@redcarpettours.net

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PACKAGING PRODUCTS FOR HEALTH CARE

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RUBBER DISCS & PLUNGER FOR DENTAL CARTRIDGES

TABLET & GELL APPLICATOR

EYE / EAR DROP BOTTLES (CONTROLLED DROP SYSTEM)

30ML, 60ML & 100ML DRY SYRUP BOTTLE WITH CAP & MEASUGINC CUP

DROPPER ASSEMBLY

RUBBER DISCS WITH EUROHEAD CAPS AND FLASH BLUB

DIAGNOSTIC PACKAGING DIFFERENT SIZE CAPS

PLASTIC MEASURING CUPS/SPOONS (for LIQUIDS & Dry Powders)/ PLASTIC CAPS (ROPP)

RUBBER WADS

BEAK TYPE DROPPER, OPVD DROPPER & BUILT IN DROPPER

DOSING SYRINGE WITH ADAPTOR

SYRUP SPOON

SCOOPS

LIDS FOR TIN CONTAINERS

SINGLE & DOUBLE SIDED FEEDING SPOON

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B-46, Girikunj Industrial Estate, Off. Mahakali Caves Road, Andheri (East), Mumbai - 400 003. INDIA. Tel.: +91-22-2687 5361 - 64 l Fax: +91-22-2687 5221 / 22 Email: marketing@brworksindia. com l Website: www.bharatrubberworks.com EXPRESS PHARMA

May 16-31, 2016

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email: info@ptelectronics.in May 16-31, 2016 63

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

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Sub-Visible Particles Characterisation and Prevention Sub-Visible Particles are a cause of regulatory concern due to their immunogenic and difficult to characterize nature. Regulatory bodies increasingly insist on not only detecting and sizing sub-visible particles, but also on counting them and differentiating protein from non-protein. Malvern is the solution-provider of choice for generating confidence in the quality of injectable formulations.

Size and Count

Identify

Prevent

Nanoparticle Tracking Analysis (NTA) visualises the light scattered by particle motion and uses this information to calculate the size and concentration of each particle present

Archimedes Resonant Mass Measurement (RMM) system differentiates silicon from protein particles through analysis of particle density, whilst Morphologi G3-ID static imaging system chemically identifies particles using Raman spectroscopy

Microcal DSC is used by formulation labs around the world to screen and improve formulation stability, giving confidence in the shelf-life of a product and ensuring that sub-visible particle development is minimised

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PHARMA LIFE AWARDS

IPMMAawards pharma machinery players Seven companies were felicitated by IPMMA for '50 years of Service to Pharma Industry'

S

even stalwarts from the pharmaceutical machinery fraternity, who have served the industry for more than half a decade, were felicitated at the recently held PHARMA PRO& PACK, PHARMALAB EXPO, in Mumbai.

The seven companies, Gansons India, IMA-PG India, SB Panchal & Company, Standard Engineers, The Bombay Engineering Works, Tapasya Engineering Works, and Pharmalab India, were felicitated by the organising association, Indian Pharmaceutical Machinery Manufacturers Association (IPMMA), for “50 years of Service to Pharma Industry”.

Since its formation in 2001, IPMMA has come to represent the growing fraternity of pharma processing and packaging machineries manufacturers and pharma-allied industries of India. The 300 plus member companies of IPMMA form the backbone of the world's strongest and rapidly growing pharma-economy, with more than 11,000 manufacturing facilities. Most IPMMA members also export machineries to more than 72 countries across the world, thus playing an unseen but vital role in the global pharma sector.

The felicitation programme started with a welcome speech

by Mahendra Mehta, President, IPMAA, also CEO, Parle Global Technologies. He called on stage the Jury members in attendance, Daara Patel, Secretary General, Indian Drug Manufacturers Association (IDMA) and Viveka Roychowdhury, Editor, Express Pharma. The vote of thanks was given by Sandeep Shah, Managing Director, Erweka India followed by an evening of live music and networking dinner.

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Award winners facilitated at Pharma Pro&Pack 2016 and members of the organising association, IPMMA

Gansons India

IMA-PG India

Anjali Faria, one of Gansons' longest serving employees, accepted the award on behalf of Gansons India

Richard Menezes, Director – Sales, IMA-PG India received the award on behalf of IMA-PG India

About the winners Gansons India

packaging, material handling, coating, particle size calibration and mixing.

Gyanendra Nath ‘Gan’ Banerjee started Gansons on August 19, 1947--just four short days after independence--to initially manufacture and distribute laboratory and other equipment. He was succeeded by his son NN ‘Nilu’ Banerjee who in turn handed over the baton to his son, Ashis, who led the development of The GansCoater, a world-class

tablet coating line, to make the company the leading brand of choice in tablet coating equipment. Today, the company supplies both standard and custom-manufactured equipment and support services for industries including pharma products, foods, agrochemicals, mineral processing, petrochemicals and energy. The product list spans solutions for granulation, drying, single pot processing,

IMA-PG India Established in 1961, by P G Rao, as Precision Gears, the company focused primarily on the manufacture and export of blister packing machines, pharma packaging machines, etc. It entered into a joint venture with IMA S.p.A, Italy facilitating

transfer of technology for K 150 cartoning machine by IMA. It became part of the IMA Group in1995 as IMA-PG India. In 1978, IMA-PG India forayed into the manufacture of rotary motion, vacuum forming and blister packing machines under technical collaboration with Hassia Verpackung Maschinen GmBH of West Germany. The company's core competencies today include blister packing

machines, cartonator machines, tube filling machines, counting lines, end of line solutions etc.with a capability of providing complete turnkey solutions from its wide offerings from India as well as from IMA Safe division of Italy.

The Bombay Engineering Works

SB Panchal & Company

SB Panchal & Company Established in 1947 by founder Chaturlal B Panchal as a workshop catering to fabrication needs midst the raw material market, the company's fabrication skills gradually bagged them long standing contracts from global names like Kilburn (for tray dryer manufacturing) and Sapphire Machines (fluid bed dryers).

The second generation represented by Amratlal C Panchal and his brother, created the brand SB Panchal, from mere fabrication contractors to quality machine manufacturers, which became synonymous with trouble-free drying systems.

The new millennium saw the inclusion of Hiren Panchal and Dharmik Panchal, who developed new products and systems for pharma coating applications.

Amratlal C Panchal accepted the award on behalf of SB Panchal & Company

Standard Engineers

Viren Joshi, Partner, The Bombay Engineering Works accepted the award

Tapasya Engineering Works

Vineet Shroff, CEO, Standard Engineers collected the award

Satyapal P Bakshi and Devashish 'Dev' Bakshi accepted the award

Standard Engineers Since its establishment in1962, Standard Engineers has grown to be a leading manufacturer, exporter and supplier of mixers, agitators, stirrers, blenders, dispersers, homogenisers, grease kettles, fermenters, polymerisation reactors, allied mixing equipment, etc.

The Bombay Engineering Works The company was established in 1964 to carry out custom build sheet-metal fabrication jobs, and soon started manufacturing all types of ovens, tray dryers, etc. specifically for applications in pharma, chemicals, breweries and food industries. The company has gone from strength to strength and expanded its manufactured product range and now offer a complete range of equipments and machines for all dosage forms. Today, the company offers state-of-the-art GMP models with the options for fully automatic PLC controls for various process equipments, designed to suit specific end

processes as required by the client's product. The company also offers a wide range of machines in R&D and pilot plant models of various capacities which suit a specific end use.

The company has also successfully set up complete projects on turnkey basis both in India and abroad and exports to more than 20 countries around the globe.

Tapasya Engineering Works Tapasya Engineering Works was founded more five decades ago by Satyapal P Bakshi. Today, the company is a leader in granulation equipment and services, with a presence in 37 countries and ISO certification of its processes. Representing the next generation, Devashish 'Dev' Bakshi, has grown his father's enterprise to further heights. It is reportedly the only pharma machinery company in India to have grown 30 per cent year on year since 2010. Positioned as an 'innovative granulation company offering integrated process and validated solutions partnering

To subscribe: bpd.subscription@expressindia.com

IPMMA represents the fraternity of pharma processing and packaging machineries manufacturers and pharmaallied industries pharma entities worldwide', Tapasya today has global alliances with KORSCH AG, Germany, Thomas Engineering of the US, Micromacinazione, Switzerland, and Okawara, Japan.

Pharmalab India Set up in 1962 by three enterprising veterans, Puroshottam

Pharmalab India

The award was accepted by Kirit N Shah, Director, Pharmalab India

Shah, Narharilal Shah, and Kantilal Parikh, who were experts in the manufacture of hospital equipment and laboratory machines, Pharmalab India is today recognised for constant upgradation, innovation and customisation and provides state-of-the-art technology and equipment for filtration, sterilisation, processing, packaging and water for injection plants, specialising in pro-

viding solutions following GMP guidelines. The company serves the lifesciences and biotech sectors as well as beverages, breweries and distilleries, paints, agro chemicals and dyes, FMCG and cosmetics, and food and dairy.

Pharmalab India has alliances with KPA Germany, France based SERAIL, the Swiss SKAN, Frande based Tournaire and US Unibloc-Pump.

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PHARMA LIFE CAMPUS BEAT

Smriti College of Pharmaceutical Education, Indore organises seminar on herbal medicines 'Herbal medicines: Journey from lab research to marketed formulations' was the theme for the one-day seminar A NATIONAL seminar on 'Herbal Medicines: Journey from lab research to the marketed formulations' was held at Smriti College of Pharmaceutical Education, Indore, on April 29, 2016.

Sponsored by Madhya Pradesh Council of Science & Technology (MPCST), the seminar was inaugurated by the Chief Guest, Dr Pavan Kumar Dubey, Group Director, Swami Vivekanand Group of Institutions, Indore and the Guest of Honour, Dr Arun K Gupta, Principal, RKDF Institute of Pharmaceutical Sciences, Indore. Chief Coordinator, Dr AG Hariharan and Convener Dr Neelesh Malviya, welcomed the guests.

The speakers at the event were Prof SH Mishra, Visiting Professor, Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat; Prof Ajay G Namdeo, Department of Pharmacognosy, Poona College of Pharmacy; Bharati Vidyapeeth University, Pune; Sanjay Gyanee, Managing Director, Alchemy Chemicals, Ujjain; and Prof Anil U Tatiya Department of Pharmacognosy, RC Patel Institute of Pharmaceutical Education & Research, Shirpur.

In the first lecture, Prof (Dr) Mishra gave a presentation on Rasayana of Ayurveda and New Drug Discovery. The second guest speaker was Dr Ajay G Namdeo, who gave a presentation on the topic, 'Application of Medicinal Plant Biotechnology in Production of Phytopharmaceuticals'.

Plant secondary metabolites are economically important as drug, fragrances, pigments, food additives and pesticides.

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The seminar was attended by 240 delegates.

Renowned academicians shared novel ideas and their research experience The seminar was attended by 240 delegates. Renowned academicians shared novel ideas and their research experience. They touched on various aspects of research in herbal drug discovery that involves a multifaceted approach combining botanical, phytochemical, biological, and molecular techniques. The ob-

jective of the seminar was to provide novel inputs on herbal drug discovery and development from medicinal plants.

The seminar also highlighted the latest scientific breakthroughs and explored innovative technologies as well as approaches through a poster presentation.

The abstracts for the

poster presentation comprised themes such as Pharmaceutical Technology, Medicinal Chemistry, Pharmaceutical Analysis, Quality Assurance, Pharmacognosy, Phytochemistry, Pharmacology and Toxicology and Regulatory Affairs.

The valedictory session was chaired by Dr Love Ku-

mar Soni School of Pharmacy, DAVV Indore, and Dr RV Sheorey Modern Institute of Pharmacy Prizes were distributed to the winners of the poster presentation competition. Rakesh Barik and Malviya gave the vote of thanks. The conference was well received by all the guests and delegates.

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18,PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001