TLP INSIGHT issue 6

THE LOGISTICS PORTAL MAGAZINE

TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE

Issue 6 - 2014

THE REPORT

OPERATING A

GLOBAL TEMPERATURE CONTROLLED SUPPLY CHAIN

well serviced

Reliance Depends on Preventative Maintenance TLP Insight: a journal for the life science logistics industry AIR CARGO - RFID - TEMPERATURE CONTROL - CLINICAL - BIO PHARMA - LOGISTICS

//MAIN CONTENT

TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE

MANAGING DIRECTOR Lee Atkinson MANAGING EDITOR Bridget Langston CONSULTANT EDITOR Tony Wright SENIOR DESIGNER Joey Graham info@designedbyjoey.co.uk

8

Reliance Depends on Preventative Maintenance

Tony Wright, CEO Exelsius Cold Chain Management Consultancy in his White Paper brings us up to date with news about the active aircraft container, CSafe RKN.

procedures. The aim is to verify the internal temperature at multiple positions within the cargo compartment against previously calibrated sources to ensure performance consistent with the date of manufacture.

FEATURED ARTICLE

The CSafe RKN temperature data logging capability, which can retain individual shipment data throughout the transportation journey, is similarly tested for accuracy against calibrated source data. This validation testing has become an essential requirement for the pharmaceutical users of the container particularly as transport qualification has become a firm part of GDP regulatory requirements. It makes practical sense to be assured that your valuable and temperature-sensitive shipment is inside a container that has been regularly validated for temperature accuracy.

EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson, Amy Firth ADMINISTRATION Katie Galelli WEBSITE DESIGN Knut Henriksen

CONTACT US Sales: info@intensivemedia.co.uk

Another key check is the batteries. Though the batteries used by CSafe are designed with a minimum service life of five years, they are tested annually and replaced much earlier by CSafe as part of their industry leading Preventive Maintenance Rebuild (PMR) Program that occurs every three years. This early replacement ensures optimal performance and reliability.

Subscription: subscription@intensivemedia.co.uk

Before the container can finally be released, a further check is carried out on the functionality of safety items such as the smoke detectors and power distribution systems mandated by the FAA.

December by Intensive Media Ltd. Printed by Premier Print &

Today, we have come to take a high level of reliability for granted. We assume that the temperature-controlled container supplied by our airline or forwarder works properly, not just at the start of the journey, but through all the many and varied handling points. We assume that someone, somewhere has taken efficacy and patient safety with the same level of concern, in terms of equipment maintenance, equivalent to the manufacture of the medicine and its final dispensation.

Operating With at least one company you can!a global temperature

10

controlled supply chain

For more information on the CSafe air cargo container please visit our website www.CSafeGlobal.com

Cold Chain IQ brings you an in-depth report based on individual interviews with over 100 experts from the pharmaceutical and medical devices distribution chains. The report shares their daily challenges and how they seek to overcome these.

TLP INSIGHT Is published 4 times a year March, June, September & Direct Mail Group.

Send address changes to: 145 - 157 St Johns Street London EC1V 4PW United Kingdom The opinions and views expressed by the authors in this book are not necessarily those of the Editor or the Publisher and, whilst every care has been taken in the preparation and design of this book, the Editor nor the Publisher are not responsible for such opinions and views, or for any inaccuracies in the articles.

Whilst every care is taken with artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred, The entire content of this publication is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form, by any means – electronic, mechanical, photocopying or otherwise – without prior permission of the Publisher.

Copyright© 2013 Intensive Media Ltd

Contents continue on page 4 »

he Right Temperature® and Peace of Mind® are registered trademarks of CSafe Global. © 2014 CSafe Global.

TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

//FEATUREDCONTENT

32

IATA Standards: Transportation of Time and Temperature Sensitive Products

Andrea Gruber, Manager Cargo Business,Process & Standards is responsible at IATA for the regulations related to the transport of Live Animals, Perishables and Healthcare Cargo and for delivering the standards and processes for the air cargo supply chain. DaveBrennan, Assistant Director Cargo Safety and Standards, is responsible for coordinating the activities of the Cargo team who are jointly responsible for the IATA standards publications and products that address dangerous goods transported by air. Together they detail the framework in which the Life Science Logistics industry needs to work, and the ways in which IATA are responding to challenges presented by transporting time and temperature sensitive products.

38

Track and Trace: Nothing is Impossible

An interview with Taha Yayci, consultant for the Turkish Ministry of Health and owner of TechNarts on the importance of serialization and how Ä°TS, the Turkish Pharmaceutical Track and Trace System defines the infrastructure in Turkey and leads the way in the world.

44

Environmental monitoring

Dr Nicola SpiggelkĂśtter with considerable experience in helping companies negotiate the GMP-regulated world, shows us the way to look at the stories behind the graphs to make sure we are interpreting that temperature data correctly.

4. TLPINSIGHT

www.the-logistics-portal.com

a high technology smart box For highly secure shipping

STP is a division of Sofrigam www.sustainablethermalpackaging.com

TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

//TLP INSIGHT FOREWORD As we go to print the FIFA World Cup is underway, an event that sees the representatives of thirty-two nations facing exciting challenges over the course of a month. The winning team will be the one that faces those challenges in the best-prepared, most positive frame of mind. Sometimes there is an element of luck, or an incident of unfairness, but on the whole the best team wins.

And so it is in the world of the life science logistics industry. The only difference is that the teams involved here are dealing with supreme challenges not just once every four years, but every day of every year. Some of these are on a global scale as the global pharmaceutical supply chain continues to grow and grow with more and more players involved as outsourcing and offshoring continues to trend. Manufacturers and distributors alike need to address the concerns together to ensure robust supply chains and insights into quality management on a global scale, such as those offered by Cold Chain IQ, are invaluable.

Some teams’ work takes place, at least initially, on a national scale. Perhaps driven as in this case, by cries of ‘foul’ as a team responded to the concern of counterfeit drugs in the Turkish supply chain. iTS was born and in an interview with Taha Yayci we find out more about how and why the Turkish Pharmaceutical Track and Trace System became the first successful and unique application of its kind in the world. Now, there’s a winner.

Just like any great football team, it’s often what goes on in the background that makes the difference between winning and losing.

And in the very complex world of active aircraft containers there are experts, such as Tony Wright, CEO Exelsius Cold Chain Management Consultancy who talks to us in his White Paper about how the scheduled maintenance programme of the CSafe RKN ensures reliable end-to-end temperature performance and aircraft safety. No mean feat!

As always, we hope you enjoy this quarter’s TLP Insight and are able to take away from it something that will inspire you and help better prepare your team to face its challenges.

Lee Atkinson Managing Director Intensive Media

6. TLPINSIGHT

www.the-logistics-portal.com

THE LOGISTICS PORTAL MAGAZINE

Biotec Trusted Globally To Deliver

High Quality Clinical Supplies Services Biotec has established itself as a truly international trusted partner delivering clinical supplies services.

Our services include:

Biotec have built a global reputation as a company with the commitment to quality and technical excellence, the accredited expertise and the in-depth experience needed to take your clinical trials from Phase I to Phase IV and onto commercial supply.

Biotec Services International Ltd Biotec House, Central Park, Western Avenue, Bridgend Industrial Estate, Bridgend, CF31 3RT, UK

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

Reliance Depends Reliance Depends on Preventative Maintenance on Preventative Maintenance

White Paper

TLP

May 2014

Reliable End-to-End Temperature Performance

Reliable End-to-End Temperature Performance

No getting away from it, some things in life are now much easier than they used

No getting away from it, some things in life are now much easier than they used to be. When I bought my first car, it was all about speed, color and girls would attract.

How much time and money I wouldtime have and to spend to keep it yes,it how many girls it would attract.

How much money I would roadworthy, and ittowas plenty, came as a secondary consideration to allasofathese. have to spend keep it roadworthy, and it was plenty, came secondary consideration to all of these. to be. When I bought my first car, it was all about speed, color and yes, how many

When choosing a car, I still go for color and speed (reluctantly having to drop the

When choosing a car, I still go for color and speed (reluctantly having to drop the ‘girls’ part if I want to stay married!) and like many of you, I have a package included in my lease contract. If it needs attention, I take it back to the dealer. maintenance package included in my lease contract. If it needs attention, I I have to to relythe on dealer. the ease Iwith which thetocar canon bethe backease on the road and/or a car take come it back have come rely with which the temporary replacement beingand/or arranged.

Quick, simple and convenient with no dirty can be back on the road a temporary replacement being arranged.

Quick, simple and convenient with no dirty hands. hands. ‘girls’ part if I want to stay married!) and like many of you, I have a maintenance

Tony Wright, CEO Exelsius Cold Chain Management Consultancy

In the world of temperature-controlled transportation, the word ‘rely’ has also come to mean a great deal in terms of end-to-end temperature to mean a great deal in terms of end-to-end temperature assurance. In our teaching assurance. In our teaching classes at Exelsius, we often update the slide classes at Exelsius, often updatehave the slide shows how many airlines have that shows how we many airlines nowthat launched a specific healthcare/ now launched a specific healthcare/pharmaceutical service using containers. pharmaceutical service using active containers.

With theactive recent addition of Saudia Cargoaddition and Qatar Airways, it isand approaching 35 itairlines whom shippers With the recent of Saudia Cargo Qatar Airways, is approaching 35 and manufacturers now rely on for the correct temperature management airlines whom shippers and manufacturers now rely on for the correct temperature in an ever more complex international transportation environment.

In the world of temperature-controlled transportation, the word ‘rely’ has also come

management in an ever more complex international transportation environment.

But just as with cars, reliance depends on maintenance. And for the

But just as with cars, depends on maintenance.

And for the manufacturers manufacturers of reliance these active aircraft containers, it means a scheduled

ofmaintenance these active aircraft containers, it means a scheduled The program.

The fact that these activemaintenance containers program. are ‘aircraft

equipment’ therefore, to the regulatory of to the fact that these and active containerssubject are ‘aircraft equipment’ andrequirements therefore, subject airworthiness inspection authorities,inspection makes it authorities, that much makes more itcomplex, regulatory requirements of airworthiness that much

particularly when we know that aircraft safety is a prime concern along with the thermal performance of the container.

more complex, particularly when we know that aircraft safety is a prime concern along with the thermal performance of the container.

So how do companies, such as CSafe, try to ensure that we can continuously the performance of these containers that both heat and Sorely howupon do companies, such as CSafe, try tocomplex ensure that we can continuously rely upon materials? cool without the use ofcomplex external phase change the performance of these containers that both heat and cool without the use of external phase change materials?

The CSafe RKN

To maintain the highest possible performance and reliability, the CSafe RKN is routinely returned to one of their thirty factory-trained and approved To maintain the highest possible performance and reliability, the CSafe RKN is global service centers for scheduled maintenance and validation activities. routinely returned to system one of their factory-trained approved global service An asset tracking thatthirty diverts containers and to the most appropriate centers scheduled validation hours activities.

An asset tracking center,fordictated by maintenance date and/orand operational usage, helps manage the process. is carried out according the containers’ system thatMaintenance diverts containers to the most appropriatetocenter, dictated by date and/ records and Component Manual.is carried out orpersonalized operational hours usage, helps manage theMaintenance process. Maintenance according to the containers’ personalized records and Component Maintenance

As you might expect, temperature validation is one of the most critical aspects of the maintenance activity and at least every 12 months after release from the factory, the container is vigorously tested in accordance with validation

Manual.

As you might expect, temperature validation is one of the most critical aspects of the maintenance activity and at least every 12 months after release from the factory, the

www.CSafeGlobal.com info@CSafeGlobal.com

container is vigorously tested in accordance with validation procedures. The aim is to verify the internal temperature at multiple positions within the cargo compartment

CSafe®, AcuTemp®, ThermoCor®, The Right Temperature® and Peace of Mind® are registered trademarks of CSafe Global. © 2014 CSafe Global.

8. TLPINSIGHT

www.the-logistics-portal.com

THE LOGISTICS PORTAL MAGAZINE

White Paper

Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

TLP

White Paper

Reliance Depends on Preventative Maintenance

The word ‘rely’ has come to The word ‘rely’ mean a great dealhas come to mean great deal in terms of aend-toin terms of end-to-end end temperature temperature assurance.assurance.

against previously calibrated sources to ensure performance consistent with the date of

procedures. The aim is to verify the internal temperature at multiple positions within the cargo compartment against previously calibrated sources to ensure performance consistent with the date of manufacture.

manufacture.

The CSafe RKN temperature data logging capability, which can retain individual shipment data

The CSafe RKN temperature data logging which can retain source throughout the transportation journey, is similarly testedcapability, for accuracy against calibrated shipment throughout the transportation is similarly data. Thisindividual validation testing has data become an essential requirement for thejourney, pharmaceutical users

tested for accuracy against calibrated source data. This validation testing has become an essential requirement for the pharmaceutical users of the requirements. It makes practical sense to be assured that your valuable and temperaturecontainer particularly as transport qualification has become a firm part of sensitive GDP shipment is insiderequirements. a container that has been regularly validated forbe temperature regulatory It makes practical sense to assured that accuracy. your valuable and temperature-sensitive shipment is inside a container that has been regularly validated for temperature accuracy.

of the container particularly as transport qualification has become a firm part of GDP regulatory

Another key check is the batteries. Though the batteries used by CSafe are designed with a Another key check is the batteries. Though the batteries used by CSafe are minimum service life of five years, they are tested annually and replaced much earlier by CSafe as

designed with a minimum service life of five years, they are tested annually and replaced much earlier by CSafe as part of their industry leading three years.

This earlyMaintenance replacement ensures and occurs reliability.

Preventive Rebuildoptimal (PMR)performance Program that every three years. This early replacement ensures optimal performance and reliability.

part of their industry leading Preventive Maintenance Rebuild (PMR) Program that occurs every

Before the container can finally be released, a further check is carried out on the functionality of

Before container can finally released, a further check is carried out safety items such the as the smoke detectors and be power distribution systems mandated by the FAA. on the functionality of safety items such as the smoke detectors and power distribution systems mandated by the FAA.

Today, we have come to take a high level of reliability for granted. We assume that the

temperature-controlled container supplied ourlevel airlineoforreliability forwarderfor works properly, Today, we have come to take a by high granted.

Wenot just

at the start of the journey, through all the many and container varied handling points. assume that thebut temperature-controlled supplied byWe ourassume airlinethat or

properly, at the start of the thesame journey, throughinall someone,forwarder somewhereworks has taken efficacynot andjust patient safety with level but of concern,

the many maintenance, and varied handling points.

We assumeofthat somewhere terms of equipment equivalent to the manufacture thesomeone, medicine and its final

has taken efficacy and patient safety with the same level of concern, in terms of equipment maintenance, equivalent to the manufacture of the medicine and its final dispensation.

dispensation.

With at least one company you can!

With at least one company you can!

For more information on the CSafe air cargo container please visit our website www.CSafeGlobal.com

For more information on the CSafe air cargo container please visit our website www.CSafeGlobal.com

www.CSafeGlobal.com www.CSafeGlobal.com

info@CSafeGlobal.com

www.the-logistics-portal.com

TLPINSIGHT 9.

THE REPORT

OPERATING A

GLOBAL TEMPERATURE CONTROLLED SUPPLY CHAIN Executive Summary The size of the global pharmaceutical supply chain is growing rapidly. With the increase of outsourcing and offshoring there are now more players than ever before in the distribution chain.

Ensuring the safe storage and distribution of temperature sensitive materials remains a constant challenge for the pharmaceutical industry.

THE LOGISTICS PORTAL MAGAZINE

Q-tag CLm doc – Brings everything to a point. ®

Exact evaluation

Temperature measurement

Versatility

Alarm function

Intelligence

Reliable companion

Worldwide control

Efficiency

Four new loggers with impressively good qualities. Wether simple indicators, reusable or single-use loggers, dry ice or long-term monitoring. With the fully validated Q-tag® CLm doc family, we have the right solution for any requirement.

Berlinger – The OneStopShop: www.berlinger.ch/clmdoc

Berlinger & Co. AG Mitteldorfstrasse 2 • CH-9608 Ganterschwil Phone +41 (0)71 982 88 11 • Fax +41 (0)71 982 88 39 info@berlinger.ch • www.berlinger.ch

Unbenannt-1 1

26.02.2014 14:54:14

THE REPORT

This report looks at the technologies and strategies the industry

During 2011Cold Chain IQ conducted several online surveys

is employing to leverage partnerships and streamline processes in

with the industry looking at investment levels in the temperature

their supply chains of temperature sensitive products

controlled supply chain and key challenges faced by professionals on which many of the findings in this report are based.

Over the past year Cold Chain IQ and Pharma IQ conducted individual interviews with over 100 experts from all stages of

This report also incorporates the findings of the SCA live polling

the pharmaceutical and medical devices distribution chain from

session conducted with 300+ logistics and QA professionals at

logistics to quality assurance, regulators to manufacturers. In this

IQPC’s 11th Cool Chain Logistics Europe event.

report we share their daily challenges and how they are seeking to overcome these.

With an uncertain global economic landscape, key concerns for professionals included adhering to regulations, building value into the supply chain and implement cost-effective strategies and

Overview of Temperature Controlled Logistics in 2012 Background to the 11th Annual Cool Chain Logistics Europe survey

solutions.

In February 2012 a live poll was carried out at IQPC’s 11th Against this backdrop, Cold Chain IQ set out to examine

Cool Chain Logistics Europe event where attendees from the

the current challenges of operating a global pharmaceutical

temperature controlled logistics and quality assurance community

temperature controlled supply chain and where it is heading in

were invited to participate.

2020, with the following questions in mind: The poll’s respondents represented all areas of the healthcare - What is the biggest risk in establishing a logistical partnership?

supply chain. The largest majority of respondents’ products were branded pharmaceuticals 29%, followed by biopharmaceuticals

- Which BRIC country represents the biggest opportunity?

23%, healthcare distribution on behalf of another company 16%, clinical supplies and IMPs 11%, medical device and diagnostics 7%

- What place does horizontal collaboration have in the

generics and OTC products at 3% respectively.

pharmaceutical supply chain?

Priorities for the temperature assured supply chain - What steps are companies taking to improve service levels in their cold supply chain?

A majority of respondents 69% reported that reducing or preventing product deviations and excursions as one of their top

- Where is the most innovation taking place in the pharmaceutical

three priorities in the temperature assured distribution supply chain.

supply chain?

Key Findings • 96% of respondents consider cold chain or temp control a core competency of their logistics provider • BRIC in 5 years: China will present the greatest opportunity • 63% said finding cost-effective solutions / products is their key challenge in the storage and distribution of CRT and ambient products • 71% of professionals in pharmaceutical distribution planned to increase investment over the next 10 years.

12. TLPINSIGHT

www.the-logistics-portal.com

Controlled

l Cool Chain

the current economic climate other key priorities were ensuring compliance with good distribution practice (GDP) regulations and cost reduction within the supply chain, both with 29%.of respondents.

COLD CHAIN IQ

carried out at s Europe event controlled ommunity

ted all areas of e largest s were ollowed by care company 16%, medical device d OTC

assured

eported that eviations and ree priorities in tion supply

and pressures in

As regulatory scrutiny increases and companies face increased cost pressures in the current economic climate other key

The Corporate Perspective

IQ- The priorities Global Network for compliance Temperature Controlled Logistics and www.coldchainiq.com The Quality pharmaceutical, biotech and medical device industries are were ensuring with good distribution

Page 4

under increasing pressure to ensure the effectiveness of the practice (GDP) regulations and cost reduction within the supply chain, both with 29%.of respondents.

cold chain and demonstrate measureable improvements to temperature controlled supply chain effectiveness.

Featuring lower down the rank of core priorities were reducing product theft within the distribution chain 7%, the sustainability

For over half of the respondents, patient safety with 59% of the

and environmental impact of the supply chain and moving toward

vote was the main business driver for ensuring an effective cold

the outsourcing model within the supply chain with just 3%.

chain. Followed by regulatory compliance 18%, product efficacy 11%, cost of spoilage 7% and only 4% stating brand equity.

re priorities the lity and chain and del within

edical ng s the cold e olled supply

tient safety business chain.

www.the-logistics-portal.com

TLPINSIGHT 13.

edical ng s the cold e THE olled supply

REPORT

tient safety usiness chain.

18%, ge 7% and

he BRIC

espondents RIC unity for nd Russia

as the

Opportunities and challenges:

of temperature sensitive storage and distribution.

The BRIC economies: A significant number of the survey

For many emerging markets improving the existing infrastructure

respondents – over 41% – selected China as the BRIC economy

is of key concern.

The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 5 which had the most opportunity for their business. Followed by

Brazil and Russia both with 17% and India with 14%.

Focus on: Emerging Markets

However, China was also identified as the BRIC economy that

The emerging markets present perhaps the greatest opportunity

participants thought would present the greatest challenge in the

and challenges for operating a global temperature controlled

next 5 years with 35% of respondents selecting the country.

supply chain. Many of these countries economies are still growing at a healthy, sustainable rate despite the global economic slow

Whilst many of these emerging economies have the domestic

down and are proving to be an attractive global proposition

growth, many professionals are concerned that they do not yet

for pharmaceutical companies looking to increase their global

have the infrastructure in place to support the logistic challenges

presence and invest in new areas.

Whilst wrapping up a visit to Latin America IMF Managing Director Christine Lagarde, spoke of the increasing role emerging markets will be playing in solving global problems.

Brazil In a press release she said: “As the balance of economic power shifts, emerging economies are a key part of the solution to the global problems.

14. TLPINSIGHT

www.the-logistics-portal.com

COLD CHAIN IQ of global standards among all stakeholders

“In Brazil areclinical being asked to ensure everything is alongwethe supply chain.that This requires

ps the or lled

monitored that there is proof ofand monitoring. more and stringent monitoring quality In the area of cool assurance chain that’s going to require little more diligence activity, whenaquality cannot be from us

and we are seeing timeline going much longersaid and the any of the assured the the result is additional cost,”

report. customs or logistics challenges need to be dialled into to all your

hy, conomic ttractive

estimates for supplies. At the same respect if that doesn’t happen,

The key concerns for manufacturers and distributors are accessibility, visibility and data. supplies from you,” he said.

Local regulations and import and export issues

you end up getting more excursions which will require more

obal

Pharmaceutical companiesVaccine must assume responsibility for their Ray Goff Director, Production Pfizer, product quality and safetyIQ and therefore need totime ensure that the spoke to Pharma about increased partners they work with in the supply chain comply with not only spent implementing a clinical supply in the

erica IMF spoke of will be

alance of nomies obal s an of the

o he figures h.

India Brazil consistently presents an important voice to the world on behalf of Fast-growing the interests of emerging and and developing economies.” economies large patient

pools are attracting manufacturers to conduct clinical trialsthe in UK emerging markets.

In turn Brazil hasmore recently overtaken to become the sixth-biggest increasing the demand on temperatureeconomy.this The is economy grew 2.7% last year, official figures show, controlled storage and distribution of clinical more than the UK’s 0.8% growth. supplies in high-growth regions. According to India the “BRIC Clinical Trials Report: Opportunities and Challenges”, India is primed to become a hub for clinical research and clinical Fast-growing economies and large patient pools are outsourcing activities, with over 53.5% attracting manufacturers to conduct more clinical trials in identifying India as the BRIC country with the emerging markets. In turn this is increasing the demand on greatest opportunities for clinical trials. temperaturecontrolled storage and distribution of clinical

supplies in regions.and According to companies the “BRIC Clinical “Ifhigh-growth pharmaceutical biotech do Trials Report: Challenges”, is primed to not Opportunities want to loseand quality whenIndia accelerating

is important theyoutsourcing remain aware become aclinical hub for trials, clinical itresearch and clinical activities, with over 53.5% identifying India as the BRIC country

localBRIC but also globally recognised standards. countries:

“In Brazil we are being asked to ensure that Russia

everything is monitored and that there is proof of monitoring. In the area of cool chain that’s According to Frost and Sullivan the Russian pharma market going to require a little more diligence from us is expected to be worth $37.15bn in 2016. As the region and we are seeing the timeline going much prepares for a significant growth phase, the article “Russia: longer and any of the customs or logistics Needs to Invest in Cold Chain Infrastructure for Biopharma to challenges need to be dialled into to all your Grow” examinedfor thesupplies. need to capitalise this interest estimates At the on same respectfrom if big players within the pharmaceutical by investing in its cold that doesn’t happen, you end up getting morechain infrastructure – anwhich asset which will become more important excursions will require moreever supplies as biopharmaceuticals develop. from you,” he said.

Pharmaceutical companies must assume responsibility quality and World Courier for lasttheir year product opened its temperature safety and therefore need to ensure that the controlled distribution centre, boasting “validated partners they work with in the supply chain storage areas for investigational drugs, diagnostic comply with not only local but also globally kits and medical devices”, in Moscow. It is just the recognised standards. seventh such facility the company had opened worldwide.

withNetwork the greatest for clinical trials. Logistics and Quality www.coldchainiq.com The Global foropportunities Temperature Controlled Centralised depots can significantly reduce customs Page 7

delays and improve regulatory permit process.

“If pharmaceutical and biotech companies do not want to lose quality when accelerating clinical trials, it is important they

remain aware of global standards among all stakeholders along the clinical supply chain. This requires more stringent monitoring and quality assurance activity, when quality cannot be assured the result is additional cost,” said the report.

“This is particularly important in emerging markets where interest in conducting clinical trials is growing incrementally to advancements in the local infrastructure,” said Wayne Heyland, president and chief executive office of Word Courier Group.

The key concerns for manufacturers and distributors are accessibility, visibility and data, local regulations and import and export issues.

Just over one year later it announced it was increasing storage capacity at the Moscow facility, due to high customer demand.

Ray Goff Director, Vaccine Production Pfizer, spoke to Pharma IQ about increased time spent implementing a clinical supply in the BRIC countries:

(Source: Russia: Needs to Invest in Cold Chain Infrastructure for Biopharma to Grow)

www.the-logistics-portal.com

TLPINSIGHT 15.

[RELIABILITY] Provide the best solution for the transportation of pharmaceuticals.

COOL CHAIN LOGISTICS

-SOLUTIONS PHARMA Constant Temperature Control

Dedicated Logistics Team

Contact: Cool Chain Logistics Team c/o Adrian Rayner Tel: +44-(0)1784 - 422- 637 adrian.rayner@jal.com www.jal.co.jp/en/jalcargo/

have an office located in Russia or ship temperate-controlled shipments to the country, with a further 11% planning on doing so within the next 12 months. However, almost a third

(31%) currently had no plans to start shipments to Russia in the future.

reduce customs delays and improve regulatory permit process.

"This is particularly important in emerging markets where interest inCOLD conducting CHAIN IQ clinical trials is growing incrementally to advancements in the local infrastructure," said Wayne Heyland, president and chief office of Word Courier Group. percent executive of those surveyed.

Just over one year later it announced it was increasing storage capacity at the favour domestically produced pharmaceuticals over international Moscow facility, due to high customer imports, which has led to the signing of some lucrative deals. demand.

The issue could be connected with the decision by Russia to

o

Other issues raised in the Pharma IQ survey Source: Russia: Needs to included Investthe in lack Cold of availability of specialised transport,for as mentioned by 23.1 Chain Infrastructure Biopharma to

percent Grow of those polled, which is a particular issue given Russia’s large size. Some 11.5 percent cited issues with the availability of warehousing, while 7.7 percent expressed concerns about security.

a.

Deputy industry and trade minister Denis Manturov told the

The Middle East

Moscow Times: “There’s a lag in the technological development

Kovac, www.coldchainiq.com Vice President Global Supply Chain Quality, Roche, of facilities to manufacture competitive products in obal Network forneeded Temperature Controlled Logistics andViliam Quality spoke to Pharma IQ about reducing supply chain vulnerabilities accordance with internationalPage standards.

8 ”

and improving distribution operations across the Middle East.

Outgoing President Dmitry Medvedev has also previously

When asked what he thought were the three main challenges with

declared modernisation of the pharma industry as one of his top

regards to improving distribution operations across the region, he

5 priorities.

the cold chain first.

Looking deeper into theidentified issue, problems start

produced pharmaceuticals over in

to emerge with the current cool chain provision

imports, which has led to the signi

in the country – the main one in an area where

lucrative deals.

Pharma IQ looked at how companies specialising in cold chain

“I would say that a creation of a region related temperature

facilities for the pharmaceutical industry are now catching on to

profile to implement adequate cold chain management controls,

the demand for such infrastructure in Russia.

as a first one; then, having specific andOther mutually agreed quality issues raised in the Pharma contracts of what need to be done as a second; and, finally, the

However, results from the Cool Chain Logistics survey

last piece is the training, so people’s qualifications,” he said.

the government does have the power to improve the situation.

those participants conducted by Pharma IQ in October 2011For revealed that although already shipping

survey included the lack of availab

specialised transport, as mentione

percent of those polled, which is a

temperature products Russia, authorities are making progress in boosting the appeal of sensitive their MohamedtoNasser, Managing Director, Eli Lilly, Saudi Arabia, also

issue given Russia's large size. So

customs clearance border crossing werebusiness impact of the temperature pharmaceutical market, not all are yet convinced about the cool and reiterated the significant

percent cited issues with the availa named as the biggest challenge coolchain chain controlled in supply and the unique challenges that the Middle warehousing, while 7.7 percent ex pharmaceutical delivery by 57.7 percentEastern of those surveyed. market faces, with respect to the cold concerns about security.

Some 58% of those polled said they currently have an office chain and temperature controlled distribution: chain infrastructure it has in place.

located in Russia or ship temperate-controlled shipments to the country, with a further 11% planning on doing so within the next 12 months.

However, almost a third (31%) currently had no plans to start shipments to Russia in the future.

Looking deeper into the issue, problems start to emerge with the current cool chain provision in the country – the main one in an area where the government does have the power to improve the situation.

For those participants already shipping temperature sensitive products to Russia, customs clearance and border crossing were named as the biggest challenge in cool chain delivery by 57.7

The issue could be connected with the

The Middle East decision by Russia to favour domestically www.the-logistics-portal.com

TLPINSIGHT 17.

THE REPORT

Nasser said: “The number one challenge we need to watch out

Controlled Room Temperature

for, is the climate in this part of the world is different from many other parts of the world, so if we are always concerned or careful

Temperature control is a critical part of product integrity,

about the product quality in different parts of the world, we

improper handling especially of temperature-sensitive

need to be doubly careful about the quality of our product, post

pharmaceuticals can compromise the efficacy and safety of drugs

manufacturing, during handling and distribution in this part of the

and pose just as serious implications to patients’ safety.

world.”

With the number of temperature-sensitive drugs set to rise Nasser also noted distribution to remote areas based on the

over the next few years. Controlled Room temperature (CRT) is

existing transportation systems and ensuring a closed chain even

becoming an important temperature range. Thermal deviations

beyond the pharmacy, as key challenges for the Middle East.

outside of the CRT envelope can comprise efficacy and patient safety.

One of biggest global challenges today for the pharmaceutical supply chain is ensuring supply chain integrity.

As a result, regulators around the globe are paying closer attention to temperature controls and data results from

“Some studies show up to 10% of the medicines in the market are

shipments of CRT and “ambient” products. This attention has

counterfeit, and again that’s global percentage . To ensure that

changed the industry discussion from coldchain management to

distribution challenge is very well closed and very secure against,

temperature controlled management for all ranges of product

or circumvented against counterfeit penetration, is a significant

temperature sensitivity.

challenge, and very, very important to make sure that quality medicine is reaching the patient.”

Whilst the majority of respondents of the 11th Annual Cool Chain Logistics Europe 2012 survey (83%), distributed products between 2ºC - 8ºC, the second most popular temperature range that respondents shipped their products in was 15-25ºC at 39%.

The Business Perspective: Top Tips for Developing a Cold Chain in the Middle East

Gary Hutchinson, cold chain expert in thermal packaging engineering and controlled environment logistics for

1: Look at the complementary supply chain Before applying the pharmacy supply chain, you need to look at the distributor supply chain. Can the distributor supply in a short span of time, or in a longer span of time?

biotechnology and high risk product and President at Modality Solutions predicted that the CRT supply chain landscape was set to grow.

“I think that’s going to be a huge market. I don’t think the volume is necessarily increasing, but the stance that the regulators

2: Be able to segment the type of business How much the cold product represents of my total volume, and the process and the value of those cold products versus the total volume, because I need to invest correctly on the cold supply chain.

are taking and even internal quality people at each individual

3: Maintain the security of that supply chain How can you ensure that supply chain is very well monitored and the product coming in and coming out of the chain has the right log? By ensuring that the system in place is closed and secure.

Pharma IQ asked Jim Lucie, Senior Manager for Material Control

pharmaceutical company are really starting to ask some questions about at least our product at controlled room temperature and how do we maintain that temperature and show those controls in our distribution channels as well,” he said.

at AMAG Pharmaceuticals, about what recent supply chain trends he had witnessed.

He said: “[The Industry] seems to be more focused now on the CRT portion of shipments as drugs come off 2ºC - 8ºC and they

(Source: Understanding the Importance of Cold Chain as Part of the Bigger Picture)

try to get a wider range for shipping and storage, which just makes it easier for the supply chain itself, from a drug standpoint, but it seems like there’s a new focus on control room temp from the

18. TLPINSIGHT

www.the-logistics-portal.com

COLD CHAIN IQ

ature

part of product cially of uticals can ety of drugs cations to

ccording sensitiveto the recent Pharma IQ study, orage and Distribution of CRT and Ambient w years. oducts CRT) is conducted earlier this year, increased gulatory scrutiny is being felt by the industry ure range. respect to the handling of CRT products in ethCRT e supply chain. and patient

countries with variable climates and redesigning packaging and labels which are mainly for use at chill and frozen temperatures.

products.

“A lot more questions over products are coming up for are several attempts to ma For the majority of survey respondents, cost

range especially for clinica was their greatest challenge. With finding cost manufacturers are better a effective solutions at 63% and finding cost shippers, and a little bit closer look at that even from a regulatory small number indicated packaging design at 6% as their greatest robustness of these produc effective transportation and services at 31%. n overwhelming 81% ofGary respondents thinkcold chain expert Pharma IQ asked Lucie, Hutchinson, in thermal standpoint.” challenge when distributing andJim storing CRTSenior productsManager and none shipping and should do tha egulators globe are Only a small number indicated packaging around the globe are paying closer and controlled for Material Control at AMAG Pharmaceuticals, packaging engineering identified defining stability profile and understanding regulatory rature design atand 6% as their greatest when tentioncontrols to temperature controls and results about challenge what recent supply chain trends he had environment logistics biotechnology According to the recent Pharma IQ study,for Storage and requirements. of CRT and distributing and storing CRT products and om shipments of controlled room temperature witnessed. riskAmbient productProducts and President Modality Distribution of high CRT and conductedatearlier this n has none identified defining stability profile and nd ambient products. Solutions predicted that the CRT supply chain industry Michael English, Senior Product Engineer of Packaging from cold-year, increased regulatory scrutiny is being felt by the understanding regulatory requirements.

He said: “[The Industry] seems to be more landscape was set to grow. with respect to the handling of CRT products in the supply chain.

Technologies at Merck, also highlighted the increased attention re controlled focused now on the CRT portion of shipments by the on distribution of ambient oduct as drugs come offindustry 2ºC - 8ºC and they try to get “I think that’s going to be a huge market. I don’t andfor CRT products.and storage, which a wider range shipping think the volume is necessarily increasing, but just makes it easier for the supply chain itself, the stance that the regulators are taking and ts of the 11th lot more questions over thelike control from a drug “A standpoint, but it seems even internal quality people at each individual ope 2012 of these are coming up for from there’s a new focusproducts on control room temp pharmaceutical company are really starting to products. countries with variable climates and IQ study, ts between transit there several attempts the shippers, and and a little bitare closer look at thatto ask some questions about at least our product redesigning packaging and labels which are and Ambient ular even from a regulatory standpoint.” at controlled room temperature and how do we maintain this tight range especially for “A lot more questions over the control of these mainly for use at chill and frozen temperatures. ear, increased ents shipped maintain that temperature and show those items. think manufacturers are products areclinical coming up Ifor transit and there y the industry 39%. are several attempts thisrobustness tight controls in our distribution channels as well,” better ableto tomaintain demonstrate of For the majority of survey respondents, cost RT products in range especially for clinical items.

I think he said. was their greatest challenge. With finding cost these products for ambient shipping and

manufacturers are better able to demonstrate effective solutions at 63% and finding cost should do that,” said English. robustness of these products for ambient effective transportation and services at 31%. dents think shipping and should do that,” said English.

Only a small number indicated packaging paying closer IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com design at 6% as their greatest challenge when and results Page 11

distributing and storing CRT products and m temperature nonebeidentified ollecting ambient data can a time- defining stability profile and

understanding regulatory requirements.

Michael English, Senior Product Engineer of An overwhelming 81% of respondents around onsuming and expensive project.

There arethink a regulators

Packaging the globe areassociated paying closerwith attention to temperature controls Technologies at Merck, also umber of challenges highlighted results fromprofiles shipments controlled room temperature and the increased attention by the etermining and temperature forof(15-25ºC) industry on distribution of ambient and CRT nd (15-30ºC) regimes, distributing to ambient products.

Chain IQ-beThe Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com CollectingCold ambient data can a timeconsuming and expensive project. There are a number of challenges associated with determining temperature profiles for (15-25ºC) and (15-30ºC) regimes, distributing to countries with variable climates and

Page 12

redesigning packaging and labels which are mainly for use at chill and frozen temperatures.

For the majority of survey respondents, cost was their greatest challenge. With finding cost effective solutions at 63% and

finding cost effective transportation and services at 31%. Only a timeMichael English, Senior Product Engineer of t. There are a Packaging Technologies at Merck, also with highlighted the increased attention by the for (15-25ºC) industry on distribution of ambient and CRT ng to

www.the-logistics-portal.com

TLPINSIGHT 19.

THE REPORT

Implementing a Quality Management System

Implementing a QMS involves: •

Understanding the requirements

As reducing the number of excursions and deviations in the

•

Putting procedures in place

supply chain is a key concern for the majority of temperature

•

Understanding the risk

controlled logistics and quality management professionals. The

•

Mitigating risk

11th Annual Cool Chain Logistics Europe survey also looked at the current percentage of excursions and deviations of

Implementation of a sound QMS within the temperature

temperature sensitive product whilst in the distribution chain.

controlled logistics process is increasingly expected by the shippers and the regulators.

A GOOD QUALITY MANAGEMENT SYSTEM SHOULD BE IN THE DNA OF A COMPANY - TONY WRIGHT Implementing a Quality Management System

“We have heard that there have been many adverse reactions related to product that has been delivered under unsuitable conditions,” said Dr. Mary Mazur-Melnyk to Cold Chain IQ. Maintaining quality in the supply chain is essential to successful healthcare logistics. In a recent Pharma IQ interview industry expert Tony Wright, CEO of Exelsius Cold Chain Consultancy said: “A good Quality Management System should be in the DNA ofOne a company. ” way that the industry is looking to

It found that at least 10% respondents had recorded As reducing the of number of excursions anda

overcome this challenge is implementing a management system It quality is important to understand what a(QMS). product can handle at each

deviation or excursion in above 15%chain of their deviations in the supply is temperature a key concern

step to avoid product recalls and adverse reactions.

sensitive whilst inofthe distribution chain.

One way that forproduct the majority temperature controlled

logistics and quality management the industry is looking to overcome this challenge is implementing th

professionals.

The 11 Annual Cool Chain a quality management system (QMS).

Logistics Europe survey also looked at the percentage oforganisational excursions and A QMScurrent can be expressed as the structure, deviations of temperature sensitive product procedures, processes and resources needed to implement whilst in the distribution chain. quality management. It encompasses all of the critical control points in delivering a high quality pharmaceutical customer to the

It found that at least 10% of respondents had end customer. recorded a deviation or excursion in above 15% of their temperature sensitive product whilst in the distribution chain.

A QMS can be expressed as the organisational structure, procedures, Quality should be built in from the beginning of the supply chain processes and resources needed to implement from R&D down to delivery to the end user. quality management. It encompasses all of the critical control in delivering a high quality Mazur-Melnyk said:points “A Quality Management System is key. pharmaceutical customer to the end customer.

We have all heard, quality has to be built in to the process and product, it can’t be tested in.”

Impleme

U P U M

Implemen temperat increasin regulator

“We have

A good Quality Management adverse r Speaking of the consequences of not following a quality been deli System should be in the DNA of a management system, she said: “You can see a company that has said Dr. M company - Tony Wright not followed a quality management system is testing and testing

Maintaini essential a recent Tony Wri Consulta Managem a compan

I

It is impo can hand recalls an

Quality s the suppl the end u

20. TLPINSIGHT

www.the-logistics-portal.com

Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.

Page 13

COLD CHAIN IQ

and the costs are increasing and the stability programs are

have come out of the correction process back inside the business,

increasing, product losses are increasing”.

and doing things right the first time,” he added.

When implementing a QMS one of the key challenges companies

All stakeholders in the temperature controlled supply chain need

face is how to define their quality management system and

to have quality at their heart to ensure effective temperature

understanding what the mechanism is about.

assurance.

QUALITY HAS TO BE BUILT IN TO THE PROCESS AND PRODUCT IT CANNOT BE TESTED IN - DR. MARY MAZUR-MELNYK.

Ready to take the temperature of your QMS? Here’s a simple test with Pharna IQ columnist Jon Wetzel to see where your QMS really stands: • •

Wright broke the quality management system down into three simple principles:

•

Go through your active SOPs and find any that are older than 1 year Take the SOP to the work area and watch the process. (Going to the Gemba) See how close the SOP is to the actual work being done

1. Document what you do put on record all the processes and procedures that are part of your business and your involvement

Are you running a high QMS out of tolerance fever?

in temperature sensitive logistics.

2. Put into practice some of the things you’ve written down as your process and procedures 3. Use the system to prove what your system says use the

• • • •

Don’t freak out Don’t point fingers or play the blame game Ask the workers what the best way is to get everything back up to speed Empower them to get everything back on target

quality management approach as a way of improving what you do.

Many misconceptions still surround quality management systems, such as they increase cost or provide unnecessary complications.

However as Wright highlighted not implementing a QMS can be

When you pay your staff to do a job with their hands you also pay them for their experience and intelligence. It’s your job as a company to find a way to harness that. That’s what it takes to be “Best in Class”.

more detrimental for a company:

(Source: Putting the “Quality” back into Your QMS) “Quality seeks quality. Bio-pharma manufacturers will want to do business only with those service providers that operate a quality management system, so if you don’t have one, then don’t expect to be a preferred partner,” he said.

Just in Time and Multi-Use Packaging

“I think companies not using a quality management system

Time is probably the most critical factor in the distribution of

will typically be noted for having disjointed and inadequate

temperature control clinical supplies.

procedures. They won’t, for example, have qualified their equipment to a high standard, and I think one other feature of

Running clinical trials effectively can provide a company

companies that don’t have a quality management system is that

competitive advantage and clinical supply professionals have a

they do spend a disproportionate amount of their time in the

unique understanding of just how important it is to ensure timely

correction stage, correcting things that have gone wrong, and not

dosage of patients and keep to trial timelines.

using a quality management approach to take those learnings that

www.the-logistics-portal.com

TLPINSIGHT 21.

cal supplies.

distribution.

y can provide a e and clinical ique THE rtant it is to ts and keep to

th

In the 11 Annual Cool Chain Logistics Europe survey, the majority of respondents 41% found REPORT effective reverse logistics networks a challenge.

Specialist & IT Business from Novo bout reducing of temperature y shortening the and the patient.

ges of s as much as more precise hand.

ging would be a use you have n,” said

erature ucing the

Followed by asset management and tracking

n IQ- TheDan Global NetworkSystems for Temperature and Quality www.coldchainiq.com Holst Jakobsen, Specialist & ITControlled Coordinator Logistics and distribution.

Page 16 Abhijit Bendre Business Analyst CMC Clinical Supplies from

Novo Nordisk, spoke to Pharma IQ about reducing risk in the

In the 11th Annual Cool Chain Logistics Europe survey, the

clinical supply chain of temperature sensitive IMPs and materials

majority of respondents 41% found effective reverse logistics

by shortening the lead times between packaging and the patient.

networks a challenge.

They talked about the advantages of postponing packaging

Followed by asset management and tracking at 25%, cleaning,

decisions as much as possible so that we can have more precise

reclaim or decontamination standards/methods to satisfy QA

information about demand at hand.

24%, lack of clear ROI models 23%, high initial capital outlay 14%, import/export issues 8% and lack of rental or leasing options

“Just in time printing and packaging would be a great way of reducing risk because you have less product in the supply chain,”

respectively.

said Jakobsen.

Reverse Logistics

One of key challenges for temperature controlled clinical supply is

According to Martin Wegner, Vice President of DHL Solutions

reducing the amount of overages.

and Innovations (DSI), the key drivers for implementing a reusable shipping system are availability and cost.

There are many challenges the pharmaceutical industry faces in deploying multi-use packaging solutions for European or Global

An integrated supply chain strategy that incorporates both

I BELIEVE WITH REUSABLE SYSTEMS WE CAN REDUCE COST, WHICH WILL MEET THE NEEDS THE OF THE PHARMACEUTICAL INDUSTRY, ESPECIALLY LOOKING AT GENERICS, WHERE WE SEE THE NEED FOR ALTERNATIVE AND LOW COST SOLUTIONS - MARTIN WEGNER

22. TLPINSIGHT

www.the-logistics-portal.com

Complete peace of mind for your pharmaceutical and healthcare shipments

Flying with care It is essential that the quality and integrity of your high value and temperature sensitive pharmaceutical and healthcare products is protected throughout the entire transportation cycle.

Backed by our fleet of advanced Boeing 747-8 and 747-400 freighter aircraft and a brand-new purposebuilt 3,000 m2 warehouse facility with temperature- and humidity-controlled environments at our Luxembourg hub, we offer you speedy, reliable and tailored solutions to meet your sophisticated needs.

On and off ground, your pharmaceutical products are in the best hands with our dedicated team of highly trained and experienced professionals. And, as you would expect from true pioneers, we are the first GDP certified airline in the world.

keepcool@cargolux.com | www.cargolux.com

+2째C to +8째C

+15째C to +25째C

THE REPORT

forward and reverse logistics becomes increasingly important

especially the vacuum panels, are fairly fragile in the sense that

in an increasingly globalised and stretched supply chain

they can very quickly end up losing their effectiveness if they’re

management reality. Effective reverse logistics can help

damaged in transit. So, you’re going to have to put some sort of

manufacturers reduce 40- 60% costs by only 20% of the

inspection or requalification in place to make sure the equipment

EVERYONE’S GOAL IS TO SUCCEED AND SEE THEIR COMPOUND THROUGH REGULATORY APPROVAL AND THROUGH TO COMMERCIAL SUCCESS. REVERSING THE PROCESS DISTANCES YOU FROM THIS GOAL - ROBERT BRONSTEIN manufacturing effort. (Tan, A.W.K. and Hosie, P. 2010) Reverse

that you sent out is still viable.”

logistics is all about setting metrics for cost saving and efficiencyboosting investments.

It is crucial to build a robust quality assurance process to avoid costly delays. For all companies their experience of forward

The main challenge is to devise a reusable system that will have

logistics is greater than of their reverse logistics. “Everyone’s

lower cost than a oneway system.

goal is to succeed and see their compound through regulatory approval and through to commercial success. Reversing the

Wenger spoke to Cold Chain IQ about the need for a smart

process distances you from this goal,” said Robert Bronstein,

solution to overcome this challenge: “The availability plays a big

Director of Clinical Supply Operations, MacroGenics.

role in this, because in a lot of cases we face imbalanced trade lanes so we have demand in one way, but no demand the way

The need to reduce risk in reverse logistics is just as important

back, which this puts a challenge on the containers, because you

as for forward logistics. “Risk mitigation for the reverse supply

would have to transport them back without any goods inside,

chain is difficult and requires planning for all possible outcomes.

which again increases the cost.”

You must always have a plan ready to execute should it become necessary to reverse the clinical supply chain or recall a product

In the next 2- 3 years Wenger believes we will see a big uptake

or component,” Bronstein said.

in reusable systems due to cost pressure especially in the transportation of generics.

Bronstein shared an example of one of the processes that MacroGenics have in place to bring supplies back.

“I believe with reusable systems we can reduce cost, which will meet the needs the of the pharmaceutical industry, especially

When initiating a site they have the site fill out documentation

looking at generics, where we see the need for alternative and low

with regards to their destruction capabilities. Should anything

cost solutions based on reusable systems.” he said.

negative occur at the site, can they destroy product at the site or do they need to return? This enables MarcoGenics to plan a

In contrast, some also question whether reverse logistics really

strategy in advance.

save money, when further validation is always required to ensure temperature assurance and re-testing of equipment is required to

In order to measure the success of reverse logistics, goals must be

make sure packaging is still reusable.

set for customers and partners and evaluating your outsourcing partners’ capabilities in reverse logistics.

Gary Hutchinson, President at Modality Solutions commented: “I don’t think reusable packaging systems are going to get much of

There will also be an increased demand for visibility and tracking

an uptake because I think the challenges are just really too great.”

in transport logistics.

He continued: “Because a lot of the reusable technologies,

24. TLPINSIGHT

www.the-logistics-portal.com

COLD CHAIN IQ

Green Initiatives

packaging by 10% means that 10% of the resources needed to produce the packaging are wasted, and extra fuel will be needed

The pharmaceutical industry like many other industries around

to distribute it. However, under-packaging that results in the

the world is facing pressure from the public and governments to

product being spoilt or damaged wastes 100% of the resources

reduce their environmental impact.

used to produce both the contents and its packaging, and all the fuel used to distribute it,” he said.

As focus shifts towards reducing carbon emissions, the pharmaceutical industry finds itself facing a dilemma in

Mark Goh, Director of Industry Research, The Logistics Institute

maintaining strict safety standards while improving its

of Asia Pacific, told Cold Chain IQ, in order to ‘go green’ in the

environmental credentials.

pharmaceutical cold chain, you must first identify the areas where you can green and which are going to be more amenable.

In “Cutting Waste in the Cold Chain” Geraint Thomas, Technical Director at Laminar Medica wrote: “The suppliers and users of

He said: “I think the low hanging fruit in this case would be the

temperature controlled packaging systems are under increasing

secondary packaging. And today the good news is there are smart

pressure to reduce the environmental impact of cold chain

astute service providers out there in the market place who are

shipping. The widespread introduction of formal corporate social

focusing very strongly on making sure that packaging is reusable

responsibility policies, together with new customer expectations

and particularly in the area of secondary packaging.”

and more strict regulations, mean that developing a suitable packaging system is more challenging than ever.”

Goh commented on the fact that we are already seeing investment by logistics providers in this area.

But can a resource and energy intensive area like cold chain ever become truly sustainable?

“Good service providers in logistics, such as UPS and DHL in fact have invested good money into this area. One example that UPS

The Cold Chain IQ article “Can the Cold Chain Ever Become Truly

is doing, is to look at the end of life of products and packaging.

Sustainable?” addressed this challenge: “In many countries around

If done correctly it goes a long way to recapture much of we

the world the idea of an environmentally-friendly cold chain is just

produce and not really consume directly.”

not viable. This does not represent a lack of commitment to green issues, but more the challenge of establishing even a basic cold

“Today in the context of Asia, there are legislations that are

chain in the first place,” said the IQ.

driving the use for reusable packaging more so than the customers or the companies themselves, and that is a good sign,”

Thomas explained the importance of considering how your

he continued.

temperature controlled packing system impacts on the environment, and suggested approaches for minimising both your

However, there are still many doubts as to how green the

waste and costs.

pharmaceutical cold chain can be.

TODAY IN THE CONTEXT OF ASIA, THERE ARE LEGISLATIONS THAT ARE DRIVING THE USE FOR REUSABLE PACKAGING MORE SO THAN THE CUSTOMERS OR THE COMPANIES THEMSELVES. THAT IS A GOOD SIGN - MARK GOH “While it might seem at first necessary to reduce the amount of

“Personally I doubt if we could have an entire green cold chain

packaging used, it is important to note that under packaging is

from source to point of supply. Certain links can certainly be

usually far worse for the environment than over-packaging. Over-

greener than others. The biggest challenge would be to have

www.the-logistics-portal.com

TLPINSIGHT 25.

THE REPORT

Outsourcing is now a fundamental part of drug development and distribution and the Pharmaceutical Distribution survey report conducted in 2011 found that 71% of professionals in pharmaceutical distribution planned to increase investment over the next 10 years.

green vehicles which often form at least 3 links in the chain,” John

journ

Settin provi a glo pharm to str local

As pa Europ ident look f to wo supp

Ackerman Chairman South African Refrigerated Distribution Association said to Pharma IQ. The participants where asked to pinpoint the 3 main solutions in which their organisation was investing to improve the temperature controlled supply chain.

The balancing act of reducing the environmental impact of pharmaceutical cold chain distribution whilst reducing cost is growing in importance among all stakeholders.

Over stand 23% 13% busin

Building a robust green pharmaceutical cold chain is not

Outsourcing is now a fundamental part of drug development

just about the packaging. Installation of renewable energy

and distribution and the Pharmaceutical Distribution survey

technology at the warehouse and utilising alternative fuels during

report conducted in 2011 found that 71% of professionals in

distribution are also avenues being explored for reducing the

pharmaceutical distribution planned increase over Network f Coldto Chain IQ-investment The Global

the next 10 years.

supply chain’s carbon footprint.

This exploration looks set to continue as companies seek to

The report on the Pharmaceutical Distribution survey examined

implement green strategies efficiently and that can ultimately

the relationship between manufacturers and third party

reduce cost.

organisations in the temperature assured supply chain.

“Partnerships between pharma and logistics firms must be based on mutual understanding and trust if supply chains are going to

Balancing Act

work, with product integrity intact throughout the journey from lab to end user,” said the report.

The range of packaging solutions and materials now available is greater than ever, presenting many new and exciting opportunities, but it is important to think about how the materials you choose will be disposed of, and the impact this will have on the environment. The waste hierarchy provides a useful framework with which to do this. By specifying the most efficient packaging solution available, you can reduce your waste, improve the sustainability of your business, and ultimately lower your operating costs.

(Source: Cutting Waste in the Cold Chain)

Working with a New Logistics Partner in the Supply Chain Ensuring a robust temperature controlled supply chain is among the most pressing issues facing pharmaceutical and biotech manufacturers today and working with the right logistics providers is one of the keys to successful cost-effective distribution.

Setting the evaluation criteria for new logistic providers can be a complex task when defining a global strategy for temperature assured pharmaceutical distribution and it is important to strike the right balance between global and local resource.

PARTNERSHIPS BETWEEN PHARMA AND LOGISTICS FIRMS MUST BE BASED ON MUTUAL UNDERSTANDING AND TRUST IF SUPPLY CHAINS ARE GOING TO WORK, WITH PRODUCT INTEGRITY INTACT THROUGHOUT THE JOURNEY FROM LAB TO END USE - PHARMA IQ

26. TLPINSIGHT

www.the-logistics-portal.com

There

s

COLD CHAIN IQ

As part of the 11th Annual Cool Chain Logistics Europe

their peers and colleagues within the cold chain sector.

survey, participants were asked to identify the most important

As part of the Cool Chain Logistics survey, Pharmaceutical and biotech companies are taking various steps respondents were asked what they found was work with in your temperature assurance supply chain. to improve their service levels in their cold chain supply, from the biggest challenge or risk in establishing a investing in new technology and infrastructure to increasing the logistics partnership. For 39% of respondents Over half of the respondents, 55% said quality standards. number of partnerships with service providers. not having enough control or visibility was the Followed by 26% price advantage, 23% service excellence, 19% biggest risk. This was followed by defining innovation and 13% specific expertise to support their As part of the Cool Chain Logistics survey, respondents were responsibilities 23%business. and 3PLs subcontracting asked what they found was the biggest challenge or risk in to other companies 19%, devising quality Therefore it is critical to select a agreements partner who has as good track establishing a logistics partnership. For 39% of respondents not 7% respectively. Merging record of adhering to quality standards and maintaining supply having company cultures was only big risk forenough 4% ofcontrol or visibility was the biggest risk. This was chain integrity. followedcold by defining responsibilities 23% and subcontracting respondents. For 96% of respondents, toaother chain or temperature control was corecompanies 19%, devising quality agreements 7% competency of their logistic provider.

As the healthcare industry focuses on core competencies, and service respectively.

Merging company cultures was only big risk for capabilities they look for when selecting supply chain vendors to

the supply chain dynamics change, nearly 60% of participants

4% of respondents. For 96% of respondents, cold chain or

said they were likely to for innovation and influence over their

temperature control was a core competency of their logistic

packaging solutions from logistics service providers who can

service provider.

provide full turnkey solutions. Whilst 16% of respondentsCold said Chain IQ- The Global Network for Temperature Controlled Logistic

they were more likely to look for influence and innovation from Page 22

www.the-logistics-portal.com

TLPINSIGHT 27.

THE REPORT

y, d was ng a ents s the g cting

% of old

der.

Summary

e Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com

Page

In summary a global reach and local22 market expertise is essential for ensuring seamless distribution of temperature sensitive

pharmaceuticals on a global level. Manufacturers and distributors alike must address global and local challenges together to ensure a temperature assured supply chain.

Investment in new technologies and infrastructure alongside robust partnerships can reduce cost, maintain quality and increase efficiency.

As the number of temperature sensitive drugs increases in the pharmaceutical pipeline – are you ready for this explosive growth?

Interested in Finding Out More?

The ideas presented in the white paper will be discussed in further detail at our Global Series of Cold Chain and Temperature Controlled Distribution events. Hear from leading experts as to how they are ensuring the integrity of their temperature controlled logistics. To find our more or to sign up for an event, please visit www.coldchainiq.com or contact our customer services team on customerservice@coldchainiq.com.

Interested in Finding Out More?

New Look, New Format, New Ideas -­‐ Sign up Today at www.coldchainiq.com.

The ideas presented in the white paper will be discussed in further detail at our Global Series of Cold Chain and Temperature Controlled Distribution events. Hear from leading experts as to how they are ensuring the integrity of their temperature controlled logistics. To find our more or to sign up for an event, please visit www.coldchainiq.com or contact our customer services team on customerservice@coldchainiq.com.

New Look, New Format, New Ideas Sign up Today at www.coldchainiq.com.

28. TLPINSIGHT

Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 24

www.the-logistics-portal.com

COLD CHAIN IQ

Acknowledgements Cold Chain IQ would like to thank all the speakers and delegates

Join today for free! www.ColdChainIQ.com

at our events, and the members of the Cold Chain and Pharma IQ websites. This report would not have been possible without the input and views from a significant number of temperature

Appendix

controlled supply chain participants and stakeholders.

Focus on: Emerging Markets There are too many to mention them all – but everyone who has taken the time to contribute to our websites or to our events

BRIC Clinical Trials Report: Opportunities and Challenges

has shared their expertise and experiences in the storage and

http://www.pharma-iq.com/clinical/whitepapers/ bric-clinical-

distribution of temperature sensitive pharmaceuticals.

trial-report-clinical-trialsopportu/

That being said a special thank you to those whom we have

An Interview with Ray Goff, Director, Vaccine Production, Pfizer -

directly cited: John Ackerman, Abhijit Bendre, Robert Bronstein,

Clinical Trial Supply Trends and Challenges

Michael English, Ray Goff, Mark Goh, Dan Holst Jakobsen, Gary

http://www.pharma-iq.com/clinicalsupply/ videos/an-interview-

Hutchinson, Viliam Kovac, Jim Lucie, Dr.Mary Mazur-Melnyk,

with-ray-goffdirector- vaccine-produc/

Mohamed Nasser, Geraint Thomas, Martin Wegner, Jon Wetzel & Tony Wright.

Viliam Kovac: Mitigating Risk in the Global Pharmaceutical Supply Chain

An especially big thank you is due to the cold chain professionals

http://www.coldchainiq.com/supply-chainsecurity/ articles/

who took part in our Pharmaceutical Distribution, Cool Chain

viliam-kovac-mitigating-risk-inthe- global-pharma/

Logistics and Storage and Distribution of CRT and Ambient Products surveys over the course of 2011 and the 11th Annual

Mohamed Nasser, MD, Eli Lilly (Saudi Arabia): The Business

Cool Chain Logistics Europe survey this year.

Impact of Cold Chain Supply

About Cold Chain IQ Free Pharma & Biopharm Industry Best Practice Information at Cold Chain IQ

http://www.coldchainiq.com/supply-chainsecurity/ podcasts/ mohamed-nasser-md-eli-lillysaudi- arabia-the-busin/

Controlled Room Temperature Gary Hutchinson: My Do’s and Don’ts for Integrating Cold Chain

An international resource centre for the temperature control life

Management Systems

science professional, Cold Chain IQ delivers insightful, unbiased

http://www.coldchainiq.com/supply-chainsecurity/ podcasts/gary-

information about today’s ‘hot topics’.

hutchinson-my-do-sand- don-ts-for-integrating/

Members benefit by reading expert analysis, trend-setting

How are Temperature Restrictions for Ambient Temperatures

articles, listening to podcast interviews, watching video features

Affecting Packaging Design?

and top-rated presentations from IQPC’s global temp control

http://www.coldchainiq.com/beyond-2-8c-crtand- ambient/

supply chain event series.

articles/how-are-temperaturerestrictions- for-ambient-tempe/

Cold Chain IQ focuses on all areas of temperature controlled logistics, distribution and quality in pharmaceuticals and biotechnology.

Cold Chain IQ, part of IQPC, maintains the largest cool chain pharmaceutical international database, offering strategic partners, members and contributors an unparalleled opportunity to network, share ideas and disseminate best practice information across the globe with peers.

www.the-logistics-portal.com

TLPINSIGHT 29.

THE REPORT

Implementing a Quality Management System

DHL’s Martin Wegner: Implementing Cost- Effective Reusable Shipping Systems

What is a Quality Management System?

http://www.coldchainiq.com/packagingshipping- systems/videos/

http://www.coldchainiq.com/qualitymanagement/ podcasts/what-

dhl-s-martin-wegnerreusauble- shipping-systems/

is-a-qualitymanagement- system/ Gary Hutchinson on the Three Rs of Logistics: Reusable, Reverse Tony Wright on The Importance of having a Quality

& Requalification

Management System

http://www.coldchainiq.com/transportationlogistics/ articles/

http://www.coldchainiq.com/qualitymanagement/ articles/the-

gary-hutchinson-on-the-three-rs-of-logistics-reusa/

importance-ofhaving- a-quality-management-sys/

Green Initiatives Putting the “Quality” back into Your QMS http://www.pharma-iq.com/pre-clinicaldiscovery- and-

Cutting Waste in the Cold Chain - Geraint Thomas, Laminar

development/columns/puttingquality- back-into-your-qms/

Medica http://www.coldchainiq.com/packagingshipping- systems/articles/

Just in Time and Multi-Use Packaging

cutting-waste-in-thecold- chain/

Challenges in Cold Chain Logistics and Just in Time Packaging

Can the Cold Chain Ever Become Truly Sustainable?

http://www.coldchainiq.com/clinicalsupply/ articles/challenges-in-

http://www.coldchainiq.com/packagingshipping- systems/articles/

cold-chainlogistics- and-just-in-tim/

can-the-cold-chainever- become-truly-sustainable/

Reverse Logistics

Is Your Pharmaceutical Packaging Solution about to Fail? http://www.coldchainiq.com/packagingshipping- systems/articles/

REWIND: Reverse Logistics in Clinical Trial Supply

can-the-cold-chainever- become-truly-sustainable/?

http://www.coldchainiq.com/clinicalsupply/a podcasts/rewindreverse-logistics-inclinical- trial-supply/

Finding the Optimal Route for Cold Chain http://www.coldchainiq.com/supply-chainsecurity/ articles/ finding-the-optimal-route-forcold- chain/

Interested in Finding Out More?

New Look, New Format, New Ideas -­‐ Sign up Today at www.coldchainiq.com.

The ideas presented in the white paper will be discussed in further detail at our Global Series of Cold Chain and Temperature Controlled Distribution events. Hear from leading experts as to how they are ensuring the integrity of their temperature controlled logistics. To find our more or to sign up for an event, please visit www.coldchainiq.com or contact our customer services team on customerservice@coldchainiq.com.

30. TLPINSIGHT

www.the-logistics-portal.com

THE LOGISTICS PORTAL MAGAZINE Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

www.the-logistics-portal.com

TLP

TLPINSIGHT 31.

TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

IATA Standards:

Transportation of Time and Temperature Sensitive Products

is to foster a safe, secure, reliable, efficient and profitable air cargo supply chain. Specialist drugs, vaccines and emergency aid

Air cargo delivering the modern world

rely on air cargo to get where they are needed.

The global economy relies on air transport to deliver high

The market for healthcare products continues to grow and shows

quality products at competitive prices to consumers worldwide.

strong resilience to global economic downturns. An increasingly

International trade is now estimated at over USD 15 trillion and

ageing population requires access to new products and spending

about 35% of that value is transported by air.

on national healthcare programmes is an important part of many government social policies. The emergence and expansion of

With the healthcare market becoming a key engine of the global

Brazil, Russia, India, China and South Africa as major consumer

economy, pharmaceutical and biomedical industries are facing

markets will shift demand and lead to more balanced trade flows

new challenges in adapting to globalisation. Air cargo is an

in the air cargo industry. This is already being seen in China and

essential link in the consumer supply chain ensuring continual

to an extent in India. The growing middle classes in emerging

access to quality and choice but it cannot work on its own.

economies are discerning high-end consumers who will continue to sustain airfreight growth in the years to come.

The International Air Transport Association (IATA) is the industry’s global trade association and represents some 240

Understanding customer needs, anticipating them and adding

airlines comprising 84% of global air traffic. Its mission is to

value in delivery is key to achieving an effective supply chain. In

represent, lead and serve the air transport industry. In cargo, IATA

particular the healthcare industry is concerned with ensuring the

takes a supply chain approach to all its initiatives, with the aim of

integrity of sensitive products is maintained when transported

benefiting all parties (airlines, forwarders, governments, Customs

by air. IATA in collaboration with supply chain stakeholders and

and shippers). IATA delivers standards and solutions to ensure a

partners has undertaken collaborative actions to address these

safe and harmonised air transport system. IATA’s vision for cargo

concerns.

32. TLPINSIGHT

www.the-logistics-portal.com

THE LOGISTICS PORTAL MAGAZINE Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

TLP

challenge of keeping products at the correct temperature range to ensure the quality of the product is not affected in transit.

Temperature control in transport is therefore an important Mrs. Andrea Gruber

component of the industry and is continuously rising in line with

Manager Cargo Business, Process & Standards

international trade. The most important issue for the industry

International Air Transport Association

and its logistic providers is to clarify mutual expectations to minimise risks and challenges for airfreight within the cool chain.

Mrs. Gruber joined the International Air Transport Association

Temperature deviations and temperature excursions throughout

(IATA) in 2008 as Manager Business Process & Standards in the

the journey requires the establishment of a complete logistical

Cargo Division and is responsible for delivering the standards and

process to maintain the shipment integrity. Quality, reliability

processes for the air cargo supply chain.

and performance are crucial, and to achieve this dialogue, joint strategy and standardisation throughout the complete

Mrs. Gruber is responsible for the IATA regulations related to the

supply chain is needed. The shipper is ultimately responsible

transport of Live Animals, Perishables and Healthcare Cargo. She is

for ensuring the product (and any necessary packaging) is

secretary to the IATA Live Animals and Perishables Board and the

preconditioned to the required temperature, and will remain

Time and Temperature Task Force.

within a temperature range for a certain period of time, using the appropriate refrigeration method adapted to the shipping

Prior to working with IATA Mrs. Gruber worked at the International

circumstances. However the accountability is shared by all of

Road Transport Union (IRU) as head of a division implementing, at

the stakeholders within the healthcare supply chain. Meeting

the Customs and business level, tools to assist the application of

the challenges can only be achieved by cooperation between all

risk management.

stakeholders involved in the supply chain, who recognise the need for guidelines.

Mrs. Gruber studied in Geneva at the University and at the Graduate Institute of International Studies (I.U.H.E.I.) and holds a

Background

Master of Sciences in International Relations.

To address the challenges in transporting healthcare products, IATA established a dedicated working group, the IATA Time and Speed to market is essential and the healthcare industry is

Temperature Task Force (TTTF) under the supervision of the

increasingly dependent upon air cargo. It is vital to address the

IATA Live Animals and Perishables Board, a governance body

www.the-logistics-portal.com

TLPINSIGHT 33.

TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

comprised of 12 Airline members, who endorse the healthcare

David Brennan

standards for the air cargo industry recommended by the Time

Assistant Director Cargo Safety & Standards

and Temperature Task Force members.

International Air Transport Association

The work undertaken by this healthcare industry, subject matter

David joined IATA in May 2002 as the Manager, Dangerous Goods

expert Task Force (composed of airlines, ground handling

Technical Services. In April 2004 David was appointed Assistant

agents, freight forwarders, shippers, international and national

Director Cargo Safety & Standards.

organisations, airports, and equipment manufacturers) led to the inclusion of a specific chapter in the existing IATA Perishable

David is responsible for coordinating the activities of the

Cargo Regulations (PCR). Today the air cargo industry is using

Cargo team who are jointly responsible for the IATA standards

the IATA PCR as the essential reference guide for all parties

publications and products that address dangerous goods

involved in the packaging and handling and distribution by air

transported by air. David is the Secretary of the IATA Dangerous

of time & temperature sensitive healthcare products. Chapter

Goods Board and is also the Panel member nominated by IATA to

17 “Air Transport Logistics for Time and Temperature Sensitive

the International Civil Aviation Organization (ICAO) Dangerous

Healthcare Products” in the PCR specifically addresses the

Goods Panel.

temperature control management issues identified by the industry and sets out recommended standards such as the use

Before joining IATA David worked for Australia Post as a consultant

of the IATA Time and Temperature Sensitive label, developed

on Aviation Security / Dangerous Goods compliance. Prior to that

together with the air cargo supply chain, and first introduced on

David worked for Ansett Australia for a period of 26 years holding

July 1st, 2010.

a number of supervisory and management positions within the Operations Division, the last being Corporate Advisor Dangerous

Mandatory Shipping Label

Goods Compliance.

The Time and Temperature Sensitive label came about as a result of standardising the nearly endless parade of labels applied by

step resulted from a collective recommendation supported by the

shippers throughout the industry. It is a shipment label, specific

Time and Temperature Task Force and Working Group members

to the healthcare industry, which must be affixed to shipments

and endorsed by the IATA Live Animals and Perishables Board.

transported as time and temperature sensitive cargo. Regarded as a recommendation, the air cargo industry recognises this label

IATA’s aim is to ensure the integrity of the time and temperature

as a best practice. Therefore, effective July 1st, 2012 the IATA

sensitive healthcare cargo shipments and that the air cargo supply

Time and Temperature Sensitive label became mandatory for

chain is prepared to handle the demands of these healthcare

the transportation of healthcare cargo shipments transported

shipments. The application of this new requirement will enhance

as temperature sensitive cargo. The decision to implement this

the transport and handling of specific healthcare commodities with the aim of ensuring the highest quality through effective cold chain distribution. Therefore, it is imperative that airlines, ground handling agents and other stakeholders in the supply chain – including freight forwarders, terminal operators, ULD manufacturers, packaging and tracking and tracing companies – are familiar both with the regulations and the appearance of the label.

The PCR Chapter 17 requirement mandates the lower half of the label to indicate the external transportation temperature range of the shipment. The responsibility to apply and complete the label for time and temperature sensitive healthcare cargo shipments

*(The temperature indicated on the lower half of the label must match the approved transportation temperature range, e.g. +15ºC to +25ºC)

34. TLPINSIGHT

www.the-logistics-portal.com

booked as such, rests with the shipper (or designated shipper’s agent by service agreement). Though transportation begins with the shipper, IATA,

THE LOGISTICS PORTAL MAGAZINE Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

TLP

together with its members, is putting an emphasis on the initial

manufactured and/or tested lithium batteries pose a fire risk in

booking, which is the key step to successful cargo transportation

transport. All lithium batteries must be transported in accordance

and which triggers the appropriate handling and operational

with the provisions set out in the IATA Dangerous Goods

processes associated with healthcare transport. The label only

Regulations (DGR) (and ICAO Technical Instructions). Guidance

supports the booking, thus the transportation temperature range

material on the transport of lithium batteries is available at: www.

specified on the label must match the transportation temperature

iata.org/lithiumbatteries

range stated on the Air Waybill, Service Level Agreement (SLA) or Standard Operating Procedures (SOP).

Additionally, active devices must comply with the appropriate airworthiness standards regarding electromagnetic interference

To strengthen the overall supply chain, a 24-hour contact

of aircraft systems. The responsibility to comply with these

telephone number of a person knowledgeable about the shipment

requirements is with the shippers of such devices. To determine

will have to be provided at the time of booking on the Air Waybill

the requirements, shippers are advised to make contact in

as well as in the SLA or SOP, to allow contacting the appropriate

advance with the applicable airline to determine the suitability of

person in the event of a significant delay or disruption to the

including such active devices in shipments.

shipment that may impact on the viability of the contents of the shipment. More information can be accessed on the IATA website

Training

using the following link: http://www.iata.org/whatwedo/cargo/ Pages/perishables.aspx

Supply chain excellence is achieved as a result of applying fundamental principles that answer customers’ needs. Training

Monitoring devices

therefore becomes paramount. Training of staff handling sensitive cargo is crucial to ensure the integrity of the cold

In addition to the label and new healthcare requirements, IATA is

chain is maintained. For the stakeholders involved in Time

working on a number of other projects to help tackle difficulties

and Temperature Management, it is a prerequisite for the

in pharmaceutical transportation. IATA by means of an industry

implementation of the PCR and the air transport logistics of

working group, the Cargo RFID Working Group (RFIDWG) will

healthcare products. The success of a programme like Chapter

be focusing on temperature monitoring devices and their use, as

17 is based on how well it is implemented. It is essential that

currently there are no clearly defined standards that exist that

each member of the supply chain understands what their specific

permit the use of electrically active devices in cargo shipments.

requirements for compliance are, as well as those of others in the supply chain. This allows for greater understanding of the entire

The healthcare industry is increasingly using monitoring systems,

supply chain process and smooth integration. As a result, the IATA

which may be placed in individual packages, to track temperature

Training and Development Institute leads training in time and

or other parameters through the whole distribution chain. These

temperature sensitive cargo handling to ensure compliance with

track and trace devices, such as electronic temperature data

the Perishable Cargo Regulation Chapter 17.

loggers, are used on or in passive packages but different types of active containers with advanced monitoring and tracing devices

IATA is working with the industry and for the industry, and

are also arriving on the market. These active devices such as

therefore such initiatives are carried out in cooperation with the

Global Positioning System (GPS) systems raise security concerns

appropriate cold chain stakeholders in the healthcare industry.

and also issues with the potential interference with aircraft

This is only the start: there will be continuous development of

navigation and electrical systems.

the standards to reinforce IATA’s vision for a safe, secure and profitable air transport industry that sustainably connects and

In addition, it is critical to understand that most temperature

enriches our world.

monitoring devices contain lithium batteries (commonly lithium metal batteries), which are dangerous goods. Lithium batteries represent a significant safety concern.

Incorrectly

www.the-logistics-portal.com

TLPINSIGHT 35.

PROMOTIONAL FEATURE | GOOEY GLOBAL

E

Speaking on the occasion, Bessem Bikhazi, Managing Director, Gooey UK Ltd; said, "We are re-launching Gooey Data with a clear objective of facilitating database services at one place”. With the philosophy of “Buy, Append or let us arrange data for you”, the new division will be the one stop solution for all data related services that aviation-related companies usually require for their direct networking and other objectives. “Gooey, which is a pioneer company in Air Transport Information management globally has to become a huge success since its inception back in 2010 and is way ahead of its time in its alliances with companies that supports this venture. With our new-style contact databases, we hope to serve the industry in the same dedicated way with an exuded excellence and customized efforts to simplify things for marketers”, adds the director of Data, John Devos.

ntrepreneur Bessem Bikhaziis a man with an ambition to make the everyday life of the aviation businessman that little less stressful.

His well knowledgeable group of industry experts have spent the past few years developing the most powerful communication tool that allows businesses to reach key decision makers with procurement responsibilities faster than ever before.

BRANDS: Airline XL, Airport XL, Cargo XL, Handler XL, Supplier XL and Freight XL is an extension of services by Gooey which provides a host of Direct Key Contacts of CEOs, VPs and 20 other Department heads from 192 global locations.

A subscription based model (fixed fee) wherein the data and information services can be availed as per chosen package offered by Gooey including free and frequent updates.

Gooey has an extensive reach practically in all aviation verticals encapsulating over 55,000 business details followed by names, job title, email addresses and direct-dial of those key contacts.

Points in this portal allows you to Search by company name, by country, by category, IATA and ICAO, job function... etc.

To Request a Brochure, contactCharlotte Willis: info@gooey.uk.com

“WE ARE PUSHING AT AN OPEN DOOR WITH THIS ONE AND WE’LL BE GLOBAL VERY SOON.” m Bikhazi, MD: “we are pushing at an open door with this one”

Gooey was founded in 2010 with a unique concept of Aviation Information and Database marketing and has not looked back since. Gooey has lead its way to providing unmatched services in the global market roping in strong partnership and subscribers everywhere. Services of Gooey includes gaining direct access to key contacts on a platform similar to a Spreadsheet but smarter! With numerous clients from airlines, airports, airport authorities, handling agents, industry suppliers, organisations and association and conference/tradeshow organisers.

Industry players are very much in favour of this venture, remarks Bessem. “ we are pushing at an open door with this one and we’ll be global very soon.”

‘’Our mission is to help aviation professionals help themselves by simplifying processes while reducing costs and improving

THE LOGISTICS PORTAL MAGAZINE

Head of Business Development

Executive VP/ Deputy CEO Chairman/ CEO

Quality & Risk Assessment

Head of Strategy & Planning

Head of I.T Head of Technical

Head of MRO Head of Networking & Routes

Head of HR

Head of Supply Chain

Head of Flight Operations

Head of Sales/ Communication

COO CFO

Head of Inflight

Head of Commercial Services

Head of Ground Operations Head of Safety/Security

direct networkinG: Gain access to world airlines, airports & handlers direct key contacts!

Gooey has spent the last few years developing the most powerful communication tool that allows aviation professionals to reach key decision makers faster than ever before.

claim your free trial: info@gooey.uk.com www.gooey.uk.com | www.gooey-global.com

TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

Track & Trace:

Nothing is Impossible An interview with Taha Yayci Interview conducted by Andrea Charles, Editor, Cold Chain IQ

38. TLPINSIGHT

www.the-logistics-portal.com

THE LOGISTICS PORTAL MAGAZINE Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

Taha Yayci Consultant for the Turkish Ministry of Health and owner of TechNarts

Why invest in serialization?

The importance of serialization can be analyzed in three major areas. First of all, serialization of products ensures the security of public health, since it prevents counterfeit drugs. Serialization prevents counterfeit drugs in the Turkish supply chain and both consumers and stakeholders are able to validate whether a product is counterfeit or not.

TLP

“

PROBABLY THE MOST INTERESTING FACT IS TO SEE MANUFACTURERS, WHO STRICTLY STOOD AGAINST THE SYSTEM AT FIRST DUE TO ITS COST IN BOTH PRODUCTION LINE AND PRODUCT TRANSACTION, IN A BEHAVIOR OF COOPERATION WITH iTS.

”

Moreover, manufacturers that serialize their products can prevent economic damage caused by not only counterfeit drug production and sales, but also fraud sales in the supply

that stakeholders each have a different business logic and

chain. Our observations on the supply chain showed that,

requirements; therefore, we evaluated each of them separately.

some manufacturers suffered from fraud sale reports by their own representatives. iTS helped them to detect such kinds of

Dividing the implementation into phases caused stakeholders

deceitfulness.

to adapt to the system faster. At the end, manufacturers were demanding and expecting new features and modules, instead of

Finally, serialization with tracking and tracing of the serial

rejecting them. The main agenda of the meetings were changed

numbers in each transaction of the products comes with valuable

from the problems of stakeholders to their demands.

data. This data gives accurate information about the market, information for which manufacturers invest a considerable amount. Instead of investing for such data, manufacturers can

In your opinion, what is the main operational challenge manufacturers face in implementation?

produce more accurate results about the market demand, stock and production predictions. In conclusion, serialization may seem

I think the most important challenge which manufacturers faced

like a costly operation at the initial stage; however, it promises to

was to adapt their production lines as well as their business

cover this cost within a few years.

logic to the requirements of the system. The system put an extra layer to the operation of production and product transportation

Turkey leads the way in serialization, but how have the country’s requirements evolved in recent years?

between manufacturers and wholesalers.

At first in Phase 1, which excludes wholesalers, this extra layer

The key to the success of the iTS is the collaboration with

was omitted by some manufacturers to simplify this operation.

stakeholders, including manufacturers, wholesalers, pharmacists,

However, with Phase 2 of iTS, in which wholesalers were also

hospital administrators and reimbursement companies. In the

involved in the system, it was not possible for manufacturers to

development process of the system, we have held many meetings

omit sending sales notifications.

and workshops to identify the requirements, expectations and problems of stakeholders. Then, we quickly analyzed these

Therefore, those manufacturers faced an important re-

problems and responded to them as soon as possible.

aggregation problem. After such a problem emerged, we provided professional help and included new features to the system to ease

Furthermore, we have monitored the system to decide how we

their operation.

could evolve it further as well as how stakeholders have reacted to the regulative and operational changes. It was observed

www.the-logistics-portal.com

TLPINSIGHT 39.

TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

What still surprises you about enabling pharmaceutical traceability?

Probably the most interesting fact is to see manufacturers, who strictly stood against the system at first due to its cost in both production line and product transaction, in a behavior of cooperation with iTS. This can be explained by the fact that iTS was designed for public health as well as manufacturers’ own benefit. Preventing counterfeits and collecting data which may be used for decision support purposes for manufacturers, took their attention. Once they realized these opportunities, they were the most ardent supporters of the system.

What are you views on utilizing Big Data in the pharmaceutical supply chain? Is it a distraction?

“ MOREOVER, WE HAVE USED THE DATA FOR PREDICTING DRUG SHORTAGES AND DETECTING BLACK MARKETS ALL OVER THE COUNTRY AT THE ADMINISTRATIVE STAGE.

” have a valuable data set for its current stock as well as its sales and receipts. Keeping this data private and utilizing it primarily

Our observation on the Turkish supply chain showed that, data

for the own benefit of the stakeholder has been very important.

collected from the transactions of the products could be used to evaluate the supply chain. The data itself is very promising in Big

Moreover, we have used the data for predicting drug shortages

Data applications for administrative and commercial purposes.

and detecting black markets all over the country at the

The benefits of this data both for public health and profit for

administrative stage. At the end of the day, although the major

the manufacturer is still a major research field. Our analysis

purpose of the system is only to prevent counterfeit drugs and

on the data pointed up a major concern on privacy. Not only

secure the supply chain, it produced a data set which is not

manufacturers, but also every stakeholder including pharmacists

possible to collect without serialization.

40. TLPINSIGHT

www.the-logistics-portal.com

THE LOGISTICS PORTAL MAGAZINE Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

TLP

Stay Compliant Effective immediately, use the 54th Edition of the DGR Manual or your shipments may be at risk.

If you’re not using the 54th Edition of the DGR Manual your dangerous good shipment may not be compliant. Don’t risk having your shipment returned or being fined thousands of dollars because of faulty documentation, packing or labeling.

Get the 54th edition of the DGR Manual today and be current with the latest regulations for completing the Shipper’s Declaration. Remember, if you use previous editions, you are knowingly putting yourself and your company at serious risk.

iata.org/dgr www.the-logistics-portal.com

TLPINSIGHT 41.

//EVENTS CLINICAL TRIAL SUPPLY USA September 17- 19, 2014 Crowne Plaza Boston – Newton www.clinicalsupplyusa.com

12TH ANNUAL COLD CHAIN GDP & TEMPERATURE MANAGEMENT LOGISTICS GLOBAL FORUM September 29 - October 3, 2014 John B. Hynes Veterans Memorial Convention Center, Boston, MA www.coldchainglobalforum.com

CLINICAL TRIALS SUPPLY EAST COAST 2014 October 28- 29, 2014 The 12th Annual Clinical Trial Supply East Coast 2014 conference is to take place in Princeton, NJ. www.arena-international.com/ctseastcoast

COLD CHAIN DISTRIBUTION December 2 - 3, 2014 SMi presents the 9th Annual Cold Chain Distribution Conference taking place in Central London.

Driven by a strong growth in the sales of temperature sensitive healthcare www.smi-online.co.uk/pharmaceuticals/uk/conference/cold-chain-distribution

4TH ANNUAL COLD CHAIN MENA December 8 - 11, 2014 This conference, hosted by IQPC, takes place from December 8 to 11, 2014, in Dubai, UAE. www.coldchainme.com

42. TLPINSIGHT

www.the-logistics-portal.com

THE LOGISTICS PORTAL MAGAZINE Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

Protecting your pharmaceuticals whatever their destination

TLP

Reduce costs and maintain “Label Claim” temperature for shipping pharmaceuticals • Cost effective protection of ambient products • Innovative design uses only 6 components • Insulated pallet shields product from hot tarmac • Supplied with UV reflective waterproof cover • Moulded insulation panels for “Glide Fit” assembly • No coolant required – pack and ship in minutes • Flat packs to reduce delivery, storage & return costs • Manufactured from 100% recyclable materials

2

1

4

www.softboxsystems.com EUROPE

Softbox Systems Ltd. Units 1-2 Ridgeway Drakes Drive Long Crendon Buckinghamshire HP18 9BF UK T: +44 1844 203 560 F: +44 1844 203 570 E: info@softboxsystems.com

AMERICAS

Softbox Systems Inc. 1160 NW Elliot Court Bend, Oregon 97701 USA T: +1 541 389 9183 F: +1 888 610 0750 E: info@softboxsystems.us

3

INDIA

Softbox Systems India Pvt Ltd. Survey No. 146-148, Village Ajivali, Kon, Old Pune Highway NH-4, Taluka Panvel, District Raigad, Maharashtra 410206 T: +91 2232 222 380 F: +91 2143 221 789 E: info@softboxsystems.com

1. Euro & US Pallet Versions 2. UV reflective waterproof cover 3. Five Euro systems on air pallet 4. Insulated Pallet Base

ASIA PACIFIC

Softbox Temperature Control Packaging Systems Pte. Ltd. 48 Toh Guan Road East #02-115 Enterprise Hub Singapore 608586 T: +65 6316 9584 F: +65 6316 9504 E: info@softboxsystems.com

For more information about this or any other Softbox Packaging System visit www.softboxsystems.com www.the-logistics-portal.com Patent GB2459392 “Transport Container” – International Patents Pending © 2012 Softbox Systems Ltd all rights reserved

TLPINSIGHT 43.

TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

Environmental Monitoring Article By Dr Nicola Spiggelkötter

Cold Chain IQ columnist Dr. Spiggelkötter started her career at a pharmaceutical contract

How to interpret temperature data: The story behind the Graphs

manufacturer where she was responsible for the sourcing of active pharmaceutical ingredients

Temperature monitoring devices are a key device,

in China and India. In this period she audited

to provide valid data that the temperature has

suppliers in Asia and she became experienced

been maintained within a given corridor during

in international supplier qualification. Then she

transportation. Regardless of what kind of data

worked for an international consulting company

loggers are used, the obtained reports lead often to

focusing on audits, inspections, training and

broad discussions among the parties involved. In case

quality control.

of deviations, temperature excursions, a root cause analysis has to be initiated.

Since 2009 Dr. Spiggelkötter has been self-employed, working in Pharma consulting (special focus supply

The misinterpretation of temperature data is

chain, transport & storage), risk management,

frequent, as the correct understanding requires a

giving lectures, staff training and auditing services.

deep knowledge in particular of the measurement

Frequently invited as a speaker at conferences,

locations and tools and measurement. Many causes

as a Visiting Professor she gives lectures on

can lead to temperature excursions. Here is a

pharmalogistics and is a contributor to publications

summary of the most prominent facts:

on GDP, risk management, transportation and qualification. Member of an Advisory Board to

Placement of the loggers

medium-sized companies she helps them to get through the GMP-regulated world.

•

Close to cooling units / to cooling elements: low temperature will be displayed

•

Close to doors / edges: high temperature will be displayed

44. TLPINSIGHT

www.the-logistics-portal.com

THE LOGISTICS PORTAL MAGAZINE Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

• •

No stable/fixed location: due to vibration or

•

Are areas with “no load” respected?

other physical impact the position might vary

•

Does the cargo have no direct contact with

Has the location been previously proved by

TLP

inner walls?

qualification runs? Does it correspond to the cold and hot spot?

Preconditioning loading area (active cooling systems) • •

•

Incorrect handling and setting monitor device •

Has the alarm been correctly set-up?

•

Is the logger working properly? Not damaged?

•

Has the logger respected startup delays?

Is the temperature in the loading area the

•

Is the recording interval /frequency correct?

required temperature when the cargo is loaded?

•

Is the logger turned on?

Does the temperature remain within the

•

Is the battery working properly?

corridor when goods are loaded with open

•

Is there enough memory capacity for the data?

doors?

•

Is the calibration of the logger valid?

Is the set point of the cooling unit correct?

•

Has the logger correctly been turned off on arrival of goods at destination?

Preconditioning loads Temperature deviations are critical, but not all of •

Is the entire cargo correctly conditioned when

them are critical to the cargo. Thus it is crucial to

loaded?

detect the causes, to understand the story behind it. This questionnaire might be helpful to detect

Stowage methods

them and finally avoid them. Training is essential, training on “what might go wrong” and how to handle

•

Can the air freely circulate within the cargo

temperature excursions.

department?

www.the-logistics-portal.com

TLPINSIGHT 45.

TLP

THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014

//INDEX OF ADVERTISERS IFC

CSAFE

5

Sofrigram

7

Biotec

11

Berlinger &Co AG

16

Japan Airlines

23

Cargolux

31

TLP Insight

38

Gooey

41

IATA

Sales: Info@intensivemedia.co.uk

43

Softbox

Subscription: subscription@intensivemedia.co.uk

IBC

DGM

OBC

UPS

46. TLPINSIGHT

www.the-logistics-portal.com

FOR ADVERTISING INFORMATION CONTACT:

THE LOGISTICS PORTAL MAGAZINE Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

TLP

Safety first in Dangerous Goods Management

Dangerous Goods Management is all about

automated where possible to save you time

safety and minimizing risk. In air transpor tation,

and to reduce error rate to a minimum.

staying compliant with all of the many rules and regulations is not an easy task. However,

DGOffice.net was developed as an on-line

supported by DGOffice.net with its specific

application, meaning you can access it anytime

modules for air transportation, it becomes a

from anywhere in the world. Alternatively,

clean cut operation. From Packing Instructions

run it as you see fit: within your own network

to Shipper’s Declaration and ‘NOtification TO

or on a stand-alone computer.

Caption’: it’s all in the software and highly

DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790, info@dgm-sdg.com, www.dgoffice.net