Pharma Utility by Digvijay Singh

www.pharmautility.com

Pharma Utility Digital Magazine Focussed spcial issue of 24 Pages Dr. Anupama Singh Chauhan (B.H.M.S., M.C.A.H.) Page no. 10 & 11 ‘Packaging Is The Key’

Digital issue in September by PHARMA UTILITY Book your advertisement in (Pharmac)

RUBBER

CHEMICAL DRUGS PACKAGING LOGISTIC

PHARMACEUTICAL

For More Information Digvijay Singh : 99301 05077 Sandeep Shetye : 98337 50284 -Senior Marketing Manager

E pharmautility@gmail.com/marketingipft@gmail.com

PHARMA Utility

From Publisher, Pharma utility ISSN:2319-5894 (International peer reviewed journal) Subject to thane Jurisdiction

Digvijay Singh (9930105077)

harma utility has been part of the Pharmaceutical Industry for over a decade,

with its launch in 2007 our team has always tried and still continues to reach out

to the eminent companies in the Pharmaceutical sector. We always make it a point to include the whole Pharma faternity together; may it be pckaging, instrumentation, drugs, logistics. As the name itself specfies, everything which is of UTILITY in the Pharma sector is been collectivelly presented through the magzine. To represent the advertisment in the magzine we have been actively particpating in various exhibitions and conferences held by CPHI, UBM, India Lab EXPO, PHARMEC, Asia Lab EXPO, IPHEX, India Pharma, Pharma Pro Pack, India Pharma Expo and Business Excellence Award and many other well known events. The manufacturers in this sector should be publiczed on a large scale is what we aim towards doing. As India is gradually transforming into "Digital India", we have also decided to broaden our spectrum to reach more closer to our Aim. Hence forth along with publication we take our magzine a level further by stepping into DIGITAL MARKETING. By launching a E- Magzine we tend to focus towards the Global market and ensure that the gap between the manufacturers and benificeries is shortened and made much more convinient to connect. The Pharma Industries are heading towards a more competetive and reformed Global Market were cyber portals play a very vital role. The E- Magzine is launched with a "vision to broadcast the all companies related to Pharma sector at one platform". And with this we tend to contribute in the ongoing deveopment of the Pharmaceutical sector for the generation ahead.

PHARMA Utility

Associate Editor (Pharma)

Avinash Verma, Rph B. Pharm, MSc (Clinical Research), MBA (International Business), Associate Editor (Pharma) Pharma Utility

qualified and Registered Pharmacist with B. Pharma,

MSc (Clinical Research) & MBA (International Business) having sharp

technical aptitude & an ardor for management working in the area of GxP guidelines. Comfortable donning many hats - R & D, Business Development, Marketing, Operations, Communications & Finance.

Having knowledge and understanding of global regulations, pertaining to Good Manufacturing Practice, Good Clinical Practice, Good Storage & Distribution Practices, Drug Supply Chain Security Act (Track & Trace) and Serialization.

A Subject Matter Expert in the Pharmaceutical & Clinical Research Services in the area of Operations, Pharma Temperature controlled packaging & Pharma Cold Chain Management

Specialties: Pharmaceuticals, Clinical Research, Project Management, Temperature controlled packaging, Cold Chain Management, Business Development, Drug/Comparator Sourcing & Pharma Logistics.

PHARMA Utility

Events & exhibition

Events

Date

Location

Website

Computer System Validation Workshop

15-16 Nov, 2018

Mumbai

www.csvworkshopindia.com

3rd Annual cGMP Workshop

25-26 Oct, 2018

Mumbai

www.cgmpworkshop.com

3rd Edition Pharma Water Workshop

15-16 Nov, 2018

Mumbai

www.pharmawaterworkshop.com

Pharma Connect

12 Dec,

Delhi

www.pharmaconnectcongress.com

Delhi

www.womeninpharma-ipw.com

2018 Women in Pharma

13 Dec, 2018

Exhibition

PHARMA Utility

CONTENTS

Article/Advertisement

Page No.

Pharma Utility Cover

Smart Labtech Pvt. Ltd

From The Desk of Marketing Head, By Mr. Digvijay Singh

Associate Editor (Pharma)Mr. Avinash Verma

Event & Exhibition

Contents

Cleaning Validation by Mr. Avinash Verma

7-8

Combination Medicine (FDC drugs) in INDIA BANNED

Packaging is the key by Dr. Anupama Singh Chauhan

10-11

GVS Cibatech

Interview with Mr. Rajnish Agrawal, Director, EMBALLISO India.

13-14

Rhombus Pharma Private Limited

Vote of Thanks from Pharma Utility

Improved Production Yield through Computer Based Formulation/ Dispensing Solution

Pharmcy Council of India

Synokem Pharmaceutical ltd

CSC Pharmaceutical International

Skymap Pharmaceutical Pvt. Ltd

Ardent Pharmaceutical

MSC Chemical

Mettler Toledo

Published, Printed and owned by: Mr. Digvijay Singh - MAH/ENG/2007/27524 (International peer reviewed journal) Join us on Website: www.pharmautility.com Facebook: http://www.facebook.corn/PharmaUtility Linkedin: http://www.linkedin.com/pub/pharma-utility/49/a21/344 Important Statement The information and opinions presented in Pharma Utility in the issue reďŹ&#x201A;ect views of authors and not of Pharma Utility Editorial board or publisher. Publication does not constitute endorsement by Pharma Utility. Pharma Utility or publisher or editorial board including editor in chief cannot be held responsible for errors of any consequences arising from the use of information contained in this journal. For plagiarism issues, authors only are solely responsible. The appearance of advertising or product information in various sections of the journal does not constitute an endorsement or approval by the Pharma Utility and / or its publisher/ editorial board of the quality orvalue of the said product or of claims made for it by its manufacturer.

PHARMA Utility CLEANING VALIDATION by Avinash Verma

leaning validation in the pharmaceutical industry has been a topic of everincreasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). The validation of cleaning method is an important element for both qualification and process validation of drug substance and drug product manufacturing. The objective of cleaning validation is to attain documented evidence, which provides a high degree of assurance that the cleaning procedure can effectively remove residues of a product and a cleaning agent from the manufacturing equipment, to a level that does not raise patient safety concerns. When is cleaning validation necessary? 1. Product-contact surfaces - Consideration should be given to non-contact parts into which product may migrate for example, seals, flanges, mixing shaft, fans of ovens etc. 2. Cleaning after product changeover - When one pharmaceutical formulation is being changed to another OR completely different formulation. 3. Between batches in campaigns- When the same formula is being manufactured over a period of time, and on different days. Cleaning validation for biological products must comply with stricter requirements due to their inherent characteristics (proteins are sticky by nature), parenteral product purity requirements, the complexity of equipment and broad spectrum of materials which need to be cleaned. Possible contaminants: Product residues, Cleaning agent residues and breakdown, airborne matter, Lubricants, ancillary material, Decomposition residues, Bacteria, mould and pyrogens. Elements of validation: 1. Analytical test procedure. 2. Calibration of instruments. 3. Operator qualification. 4. Equipment qualification. Cleaning Mechanism: Different mechanisms are employed to remove residues from equipment such as mechanical action, dissolution, detergency and chemical reaction.

PHARMA Utility CLEANING VALIDATION by Avinash Verma Mechanical action: In this method residues and contaminants are removed through physical actions such as brushing, scrubbing and using pressurized water. Dissolution: It involves using an appropriate solvent to dissolve residues. Water is usually selected owning to being non-toxic, economical, environment friendly and does not leave any residue. However, some residues are only removed by alkaline or acidic solvents. Detergency: Detergent acts in four ways as wetting agent, solubilizer, emulsifier, and dispersant in removing the residues and contaminants from equipment. Wetting agents (such as surfactants) decrease the surface tension of cleaning solution. Chemical reactions: Oxidation and hydrolysis in which the residues are chemically changed. Cleaning Validation Protocol : Cleaning validation protocols should be developed, approved, and executed in accordance with the SOPs covering the activities in place at the time. A typical cleaning validation protocol should consist of Objective, Sampling and Testing Methodologies, and Acceptance Criteria sections. Cleaning Validation Programme: 1. Selection of cleaning method 2. Selecting the Scientific basis for the contamination limit 3. Selecting the Worst case related to the equipment 4. Selecting the Worst case related to the product 5. Establishing the storage period after cleaning. 6. Selecting the sampling method- Swab sampling & Rinse sampling 7. Selecting the analytical method- Chromatographic methods such as LC/MS, GC/MS, and HPLC, Spectrophotometric methods in the visible, infrared, or UV ranges. 8. Documentation Hence cleaning validation study to be conducted with involvement of all relevant departments such as QA, QC, and production departments. This study should be carried out according to a perfect schedule. After determination of residue type, appropriate methods must be employed to collect samples of the residue followed with analysis by a suitable method and results will be compared with the acceptance limits.

PHARMA Utility Combination Medicine (FDC drugs) in INDIA BANNED

he people of India have been made the consumers of unsafe medicines for too long and FDC ban is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs, hence Government of India banned fixed dose combination drugs (FDC drugs). Combination Drugs / Fixed dose combinations (FDCs) refer to pharmaceutical preparations containing two or more drugs in a fixed ratio. They were conceptualized on the idea that certain drugs potentiate the action of other drugs when given together. The drug review committee stated that combination drugs which have more than two active ingredients in a single dose, lacked therapeutic justification and the combinations potentially toxic, terming them “irrational” and “unsafe.” It is due to Drug-Drug interaction and Food-Drug interaction. Drugs Technical Advisory Board (DTAB) recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest. The Indian government has banned over 340 combination drugs in a blow to both domestic and foreign pharmaceutical firms, but the ban has been cheered by health activists worried about growing antibiotic resistance due to the misuse of medicines. The government has restricted its sale subject to therapeutic

justification. The health ministry's ban on FDCs included painkillers, anti-diabetic, respiratory and gastrointestinal medicines, covering 6,000 brands like painkiller Saridon, Sumocold, antibiotic Lupidiclox, skin cream Panderm, diabetes drug Gluconorm PG and various antibacterials etc. After the ban implementation, the physicians may now have to change their Rx (prescription) habit and prescribe multiple plain drugs, instead of writing one FDC, which may have a huge cost impact on the patients. Fu r t h e r, re t a i l p h a r m a c i s t s d i s p e n s e medicines based on physicians' prescriptions that mention the brand names. The banned FDCs are sold under multiple brand names, and looking into the combination of each such brand is an extremely complex process. Each pharmacy may have hundreds of brands with the same combination, and it will be difficult to identify the banned FDCs — which are given in pharmacological names and eventually may pose a risk to the patients. Though several drugs are banned or restricted for sale in India, it becomes important for the government to implement laws, strict on manufacturers, wholesalers and retailers. There should be creation of awareness amongst physicians, health professionals and general public about the Adverse Drug Reaction (ADR) of these drugs. If all these steps are taken in a well-defined and unified way….. The market for these banned drugs can be eliminated permanently and rapidly.

PHARMA Utility Packaging is the key production of a certain substance is not of any use until and unless it is stored and maintained properly till the time duration intended. Even the highest quality of drug is of no use if it is not stored and mantained in a proper manner. This is because

n the Pharma industry along with

the basic nature of chemical

production and transport, packaging of

substance is to undergo alteration even

drug and chemical substance comprises

with the slightest change in the

the major part, and plays a very

surronding. So to maintain the

significant role as well. The process of

authenticity of the drug it is neccessary

packaging is the main key in between

that a well designed packaging unit is

production and transport. Packaging

present with all the modfied and latest

differs on the basis of region,surrounding,

technologies. Also special care should be

environmental factors etc. Once a primer

taken about cleanliness and temperature

quality of drug or combination of drugs

regulation so that there is no possible

are prepared it is very neccessary that

migration of oxygen, moisture, heat,

they undergo a regulated and effective

microbial contamination etc. The main

techniques of packaging.

aim in putting so much effort is to ensure

Pharma Industry has been focusing

the health of the consumeres.

towards the packaging sector

Various material used for packaging

remarkably. There are many companies

depends on the state of the drug; weather

on large as well as small scale, which

solid, liquid or gas. Example-Blister packs,

develop highly equiped machineries and

glass bottels, metals etc. Along with the

tools which help in the optimal level of

materials there are different techniques

packaging and labelling.

of packaging as well like vaccum packing

Now the question arises, why is

etc..

packaging of drugs given such prime

As there is evolution of mankind, many

mportance? As we all know only the

new complex diseases have also come

PHARMA Utility Packaging is the key into picture per se. The human race has

as rectified spirit is used as the base of

also become resistant to many drugs

majority of drug substance prepared.

during this span of time. So as the need of

Alcohol can easily under go alteration

the hour medical science has also

from slight exposure of sunlight or any

continously been doing experiments and

minimal change in the temperature,

introduced various new drugs for the

which in turn will lead to change in the

betterment of mankind, but each of these

medicinal property of the drug and as

drugs have some peculiar features and

the end result the desired action will not

need high levels of packaging, so as to

take place. Hence it is very important

maintain there originality.

that the drugs are stored and packed in a proper way to maintain its originality. Most of the Homoeopathic medicines are stored in amber coloured bottels, as this colour is least reactive to the uv rays in the sunlight. Various rare remedies are been prepared now a days from different

HOMOEOPATHY one of the well know system of therapeutics has gained a lot of popularity in the resent times. The effectivness of this system of medicine in chronic, complex cases has lead to its

medicinal substance which are not easily available, henceforth it is mandatory that these remedies are not spolied and are of there utmost benifit to the mankind for which they have been formed.

To c o n c l u d e I w o u l d s a y

awarness among the public. Now a days Homoeopathic medicines are used widely for curative as well as preventive

Authenticity of any Drug is directly propotinal to the effectivness of Packaging.

purpose. Homoeopathic medicines are cost effective as well, this is because they can be preserved for a very long time without undergoing alteration in the quality of the medicine. This is attributed to alcohol,

Dr. Anupama Singh Chauhan B.H.M.S., M.C.A.H. } 8878112596 E anuchauhan1893@gmail.com

PHARMA Utility

PHARMA Utility Interview with Mr. Rajnish Agrawal, Director, EMBALLISO India.

1. Name few & brieﬂy describe EMBALLISO products mix & solu ons? Emballiso is a French Company and we are designer and manufacturer of Temperature controlled packaging solu on for pharma companies. We have mul ple solu on ranging from 1L to 3500L and for various dura on and temperature range. We have passive solu on for 2c to 8C, 15C to 25C, 2C to 25C and for nega ve temperature. The dura on can range from 24hrs to 240+ hrs. We use all new genera on Insula on material like Extruded Polystyrene (XPS), Polyurethane (PU) and vacuum panels. Emballiso is the ﬁrst Global Company to start recycling and rental model for our passive solu on. The Green rental programme from Emballiso op mizes the whole forwarding chain for your products. Mr. Rajnish Agrawal, Our highly performing solu ons are available in our 8 sites Director, EMBALLISO India. worldwide with collec on points in more than 80 countries.

What is market size for your products & services in India? What is the growth rate you are expec ng for the industry and what is growth rate you are targe ng for EMBALLISO for next 5 years? We cater the Pharma Cold Chain market where almost 70% of the products are temperature sensi ve. The current size of the Indian pharmaceu cal industry is $27.57 billion, and it is expected to reach a mark of $55 billion by 2020. The growing pharmaceu cal industry in India has led to the presence of sound cold chain services for the pharmaceu cal industry, which is an avid user of cold chain services, hence we are an cipa ng annual 17-20% growth for next 5 years.

What is your current market share EMBALLISO has in India and across globe? Products which are contribu ng most to top line of the company? In India we have around 45% market share and globally its 30-35%. Our SE range, Box Pallet and ULD Pallet shippers are faster moving products and we an cipate our Vype range (VIP + PCM) is the next genera on product which will take the lead due to its reusability and rental model strategy.

Any new product EMBALLISO plans to launch or add into current product mix? -Recently Emballiso has added two new range of products called “VYPE” and 'ISOGO”. These are very simple and user friendly solu on owing to its's single shape concept. These are very light products for reduc on in transport cost.

PHARMA Utility Interview with Mr. Rajnish Agrawal, Director, EMBALLISO India. -These system are designed with an integrated Hiberna on capacity that kicks in if stored in a chilled environment during transit, giving you peace of mind over the uncertain es in transport and customs procedures -These solu ons can also be integrated with data loggers with temperature readings for eﬃcient analysis and temperature control management.

What are speciﬁc steps taken to delivery quality product and service to clients? -Rental programme/ collec on module/Ready to use op ons

Impact of GST on your business? We are happy for the implementa on of single taxa on system (GST) in India which has created a transparency in conduc ng ethical business and the delivery of goods have become faster.

Research & development spending by EMBALLISO? -Emballiso has a dedicated team for con nuous analysis and development of new products. Today Emballiso has developed many products and PCM (phase changing material) brique es in our own lab.

Can you share recently completed projects and challenges faced while comple ng those projects? The Indian market is s ll under the process of implemen ng the GDP guidelines at the na onal level due to which the domes c market opt for non-validated solu ons with no data about the product quality monitoring at the ﬁnal des na on, hence we try to educate about the importance of validated packaging requirement.

Where do you see the industry in next decade years? There is a huge demand of validated packaging solu ons since almost 70% Pharma products are temperature sensi ve which is distributed in domes c and Interna onal market. The addi on of Biosimilars will lead to increase of the validated packaging.

10.

What are the challenges being faced by your organiza on? -In India the regula on for Cold chain products has to be stronger and stringent. The government has to realize this, as it deals with human health medicines. -Emballiso has been educa ng customers the beneﬁt of using good thermal insula on like XPS, PU and Vacuum panels instead of the commercial Thermocol. -S ll in India we see many incidents happening due to negligence or lack of awareness in cold chain and we don`t have control checks in place.

11.

What are your short term goals for EMBALLISO? Are you expor ng products or service, any future plans to do so? Our short term goal is to focus on maintaining the quality of our product and work on diﬀerent strategies of mul ple use op on as well as rental model in place in full poten al and educate the users about the importance of validated packaging use. Yes, we do cater UAE market from India.

12.

What is your long term vision? Our added value lies in our ability to understand your challenges and needs, in order to oﬀer you products and services, which enable you to combine performance, convenience and cost savings

PHARMA Utility

harma Utility would like to thank all participants for being a part of the 9th Annual SCM Pharma

Summit organized by UBM India on 6th- 7th September 2018 at The Westin Hotel, Mumbai.

It has been our pleasure to host as media partner at the 9th Annual SCM Pharma Summit 2018. We would like to thank the organizers and the planners who not only planned and organized this event, but also executed everything with so much of passion and zeal. We like to thank all dignitary speakers and the delegates for their enthusiastic participation in the event. We are sure that the participants must have benefitted by attending the event. The speakers shared best practices, taking into account specific issues such as temperature control, supply chain security, regulatory compliance and supplier management. It was a great meeting place for life science supply chain heads responsible for growing and managing their company's supply chains across the region. We are also very much thankful to all the sponsors of this event, without their generous support, it would not have been possible. The sponsors and Partners exhibitors were Rfxcel, PentaFreight, Va-Q-Tec, WeatherShield, Pluss Advanced Technologies, Jet freight, Pelican Biothermal, Algor Supply Chain Solution, Marken, ATA freight, Delex, EMBALL`ISO, Flyjac, Magnum Cargo. Media Partners were Cargo Connect, Pharma Utility and The Pharma Review. It's was a great platform were top minds in pharma supply chain, logistics, distribution, planning, IT, quality and sourcing to meet and share practical insights on how to achieve digitalization, end-to-end visibility, customer-first strategies, and much more! We wish you all the best and hope that you continue to be engaged with Pharma Utility for future upcoming events.

PHARMA Utility Improved Production Yield through Computer Based Formulation/ Dispensing Solution

ast changing consumer preferences, pressure from regulatory authorities and growing concerns of consumers about safety of pharmaceutical products, force the manufacturer to improve and take care about the correct formulation procedure. Numerous regional and international standards (e.g. USFDA, GMP, ISO, Regional FDA, etc.) have been created over years in order to enhance the quality and the safety of pharmaceutical products. The correct formulation and weighing procedures along with the centralized database and relevant documentation process one of the prerequisite to guaranteed consistent product quality, process safety and stability as well as to increased flexibility and productivity. Aside from regulations, unpredictable supply-chain or customer events may require investigation into production steps. If defective batches appear, the root cause of the problem must be identified and measures taken to ensure future product quality and safety. The FormWeigh.Net® system for dispensing and formulation is designed, to simplify your complex and demanding formulation needs. Thanks to the intuitive formulation process, you rest assured of stable product quality from batch to batch, while maximizing material utilization, process speed and reducing the amount of manual work involved. FormWeigh.net : Dispensing solution · Software based formulation, ensure compliance and flexible to suit any environment. · Easy to handle · Centralized Data Management · Accelerated material and data flow with batch oriented workflow · Ensure consistency & accurate results. · Barcode/Manual identification ensures correct materials are added. · Maintain user profile and password, access to authorized person. · Flexible reports, customized and standard reports, save time, full traceability and audit trails. · Batch fraction management and quantity adjustment. · Multiple formulation methods. · Functions compliant with 21 CFR Part 11 and EU 178/2002 FormWeigh.Net works alongside your processes and documents them electronically on the centralized database without compromising your flexibility. FormWeigh.Net® allows you to take control of your workflows in such a way that you are always.

For more information, contact : Snehal Naik Mettler-Toledo India Pvt. Ltd. Mumbai, Maharashtra Tel: 022-42910209 | Email: snehal.naik@mt.com |Web: www.mt.com

PHARMA Utility