tlp insight issue 6

THE LOGISTICS PORTAL MAGAZINE

TLPINSIGHTIssue 6 - 2014


AIR CARGO - RFID - TEMPERATURE CONTROL - CLINICAL - BIO PHARMA - LOGISTICS

TLP Insight: a journal for the life science logistics industry

well serviced

Reliance Depends on Preventative Maintenance

OPERATING A

TEMPERATURE CONTROLLED SUPPLY CHAIN

GLOBAL

THE REPORT


MANAGING DIRECTORLee Atkinson

MANAGING EDITORBridget Langston

CONSULTANT EDITORTony Wright

SENIOR DESIGNERJoey Graham [email protected]

EDITORIAL ASSISTANTSNicholas RidgmanJamie Ward

CIRCULATION MANAGERTony Williams

SALESRakesh Makwana, Lee Atkinson, Amy Firth

ADMINISTRATIONKatie Galelli

WEBSITE DESIGNKnut Henriksen

CONTACT USSales:[email protected]

Subscription:[email protected]

TLP INSIGHTIs published 4 times a year March, June, September & December by Intensive Media Ltd. Printed by Premier Print & Direct Mail Group.Send address changes to:145 - 157 St Johns StreetLondonEC1V 4PWUnited 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

TLPINSIGHT//MAIN CONTENT

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.

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.

Contents continue on page 4 »

Operating a global temperature controlled supply chain10

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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.

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.

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.

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.

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.

With at least one company you can!

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

www.CSafeGlobal.com

[email protected]

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

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

Reliance Dependson Preventative Maintenance8

FEATURED ARTICLE

TLPINSIGHT www.the-logistics-portal.com4.


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

//FEATUREDCONTENT

An interview with Taha Yayci, consultant for the Turkish Ministry of Health and owner of TechNarts on the importance of serialization and how İTS, the

Turkish Pharmaceutical Track and Trace System defines the infrastructure in Turkey and leads the way in the world.

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.

Dr Nicola Spiggelkötter 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.

Environmental monitoring44

Track and Trace: Nothing is Impossible38

IATA Standards: Transportation of Time and Temperature Sensitive Products

32

a high technology smart boxFor highly secure shipping

STP is a division of Sofrigamwww.sustainablethermalpackaging.com

//FEATUREDCONTENTa high technology smart box

For highly secure shipping

STP is a division of Sofrigamwww.sustainablethermalpackaging.com




//TLP INSIGHT FOREWORDAs 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


1003-Biotec-EPC-advert.indd 1 24/10/2011 11:33

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Our services include:




Reliance Dependson Preventative Maintenance

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Reliable End-to-End Temperature Performance

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 yes, how many

girls it would attract. How much time and money I would have to spend to keep it

roadworthy, and it was plenty, came as a secondary consideration to all of these.

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 maintenance

package included in my lease contract. If it needs attention, I take it back to the dealer.

I have come to rely on the ease with which the car can be back on the road and/or a

temporary replacement being arranged. Quick, simple and convenient with no dirty

hands.

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 assurance. In our teaching

classes at Exelsius, we often update the slide that shows how many airlines have

now launched a specific healthcare/pharmaceutical service using active containers.

With the recent addition of Saudia Cargo and Qatar Airways, it is approaching 35

airlines whom shippers and manufacturers now rely on for the correct temperature

management in an ever more complex international transportation environment.

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

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

fact that these active containers are ‘aircraft equipment’ and therefore, subject to the

regulatory requirements of airworthiness inspection authorities, makes it that much

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 rely upon

the performance of these complex containers that both heat and cool without the use

of external phase change materials?

To maintain the highest possible performance and reliability, the CSafe RKN is

routinely returned to one of their thirty factory-trained and approved global service

centers for scheduled maintenance and validation activities. An asset tracking

system that diverts containers to the most appropriate center, dictated by date and/

or operational hours usage, helps manage the process. Maintenance is carried out

according to the containers’ personalized records and Component Maintenance

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

container is vigorously tested in accordance with validation procedures. The aim is to

verify the internal temperature at multiple positions within the cargo compartment

May 2014

Reliable End-to-End Temperature PerformanceNo 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 yes, how many girls it would attract. How much time and money I would have to spend to keep it roadworthy, and it was plenty, came as a secondary consideration to all of these.

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 maintenance package included in my lease contract. If it needs attention, I take it back to the dealer. I have come to rely on the ease with which the car can be back on the road and/or a temporary replacement being arranged. Quick, simple and convenient with no dirty hands.

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 assurance. In our teaching classes at Exelsius, we often update the slide that shows how many airlines have now launched a specific healthcare/pharmaceutical service using active containers. With the recent addition of Saudia Cargo and Qatar Airways, it is approaching 35 airlines whom shippers and manufacturers now rely on for the correct temperature management in an ever more complex international transportation environment.

But just as with cars, reliance depends on maintenance. And for the manufacturers of these active aircraft containers, it means a scheduled maintenance program. The fact that these active containers are ‘aircraft equipment’ and therefore, subject to the regulatory requirements of airworthiness inspection authorities, makes it that much 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 rely upon the performance of these complex containers that both heat and cool without the use of external phase change materials?

To maintain the highest possible performance and reliability, the CSafe RKN is routinely returned to one of their thirty factory-trained and approved global service centers for scheduled maintenance and validation activities. An asset tracking system that diverts containers to the most appropriate center, dictated by date and/or operational hours usage, helps manage the process. Maintenance is carried out according to the containers’ personalized records and Component Maintenance 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 container is vigorously tested in accordance with validation

Whi

te P

aper

www.CSafeGlobal.com

[email protected]


Reliance Depends on Preventative Maintenance

Tony Wright, CEO Exelsius Cold

Chain Management Consultancy

The CSafe RKN

www.the-logistics-portal.com TLPINSIGHT 9.

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

www.CSafeGlobal.com [email protected]

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

manufacture.

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.

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.

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.

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.


For more information on the CSafe air cargo container

please visit our website www.CSafeGlobal.com


Whi

te P

aper

Reliance Dependson Preventative Maintenance

Whi

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aper

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.

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.

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.

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.

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.


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

www.CSafeGlobal.com

[email protected]



OPERATING A

TEMPERATURE CONTROLLED SUPPLY CHAIN

GLOBALExecutive 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 REPORT


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THE REPORT

This report looks at the technologies and strategies the industry

is employing to leverage partnerships and streamline processes in

their supply chains of temperature sensitive products

Over the past year Cold Chain IQ and Pharma IQ conducted

individual interviews with over 100 experts from all stages of

the pharmaceutical and medical devices distribution chain from

logistics to quality assurance, regulators to manufacturers. In this

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

solutions.

Against this backdrop, Cold Chain IQ set out to examine

the current challenges of operating a global pharmaceutical

temperature controlled supply chain and where it is heading in

2020, with the following questions in mind:

- What is the biggest risk in establishing a logistical partnership?

- Which BRIC country represents the biggest opportunity?

- What place does horizontal collaboration have in the

pharmaceutical supply chain?

- What steps are companies taking to improve service levels in

their cold supply chain?

- Where is the most innovation taking place in the pharmaceutical

supply chain?

During 2011Cold Chain IQ conducted several online surveys

with the industry looking at investment levels in the temperature

controlled supply chain and key challenges faced by professionals

on which many of the findings in this report are based.

This report also incorporates the findings of the SCA live polling

session conducted with 300+ logistics and QA professionals at

IQPC’s 11th Cool Chain Logistics Europe event.

Overview of Temperature Controlled Logistics in 2012

Background to the 11th Annual Cool Chain Logistics Europe survey

In February 2012 a live poll was carried out at IQPC’s 11th

Cool Chain Logistics Europe event where attendees from the

temperature controlled logistics and quality assurance community

were invited to participate.

The poll’s respondents represented all areas of the healthcare

supply chain. The largest majority of respondents’ products were

branded pharmaceuticals 29%, followed by biopharmaceuticals

23%, healthcare distribution on behalf of another company 16%,

clinical supplies and IMPs 11%, medical device and diagnostics 7%

generics and OTC products at 3% respectively.

Priorities for the temperature assured supply chain

A majority of respondents 69% reported that reducing or

preventing product deviations and excursions as one of their top

three priorities in the temperature assured distribution 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%saidfindingcost-effectivesolutions/productsistheirkeychallengeinthestorageand

distribution of CRT and ambient products

• 71% of professionals in pharmaceutical distribution planned to increase investment over the next 10

years.


COLD CHAIN IQ

As regulatory scrutiny increases and companies face increased

cost pressures in 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.

Featuring lower down the rank of core priorities were reducing

product theft within the distribution chain 7%, the sustainability

and environmental impact of the supply chain and moving toward

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

Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 4

Overview of Temperature Controlled Logistics in 2012 Background to the 11th Annual Cool Chain Logistics Europe survey In February 2012 a live poll was carried out at IQPC’s 11th Cool Chain Logistics Europe event attendees from the temperature controlled logistics and quality assurance community were invited to participate.

The poll’s respondents represented all areas of the healthcare supply chain. The largest majority of respondents’ products were branded pharmaceuticals 29%, followed by biopharmaceuticals 23%, healthcare distribution on behalf of another company 16%, clinical supplies and IMPs 11%, medical device and diagnostics 7% generics and OTC products at 3% respectively.

Priorities for the temperature assured supply chain

A majority of respondents 69% reported that reducing or preventing product deviations and excursions as one of their top three priorities in the temperature assured distribution supply chain. As regulatory scrutiny increases and companies face increased cost pressures in

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.


Featuring lower down the rank of core priorities where reducing product theft within the distribution chain 7%, the sustainability and environmental impact of the supply chain and moving toward the outsourcing model within the supply chain with just 3%.

The Corporate Perspective The pharmaceutical, biotech and medical device industries are under increasing pressure to ensure the effectiveness the cold chain and demonstrate measureable improvements to temperature controlled supply chain effectiveness. For over half of the respondents, patient safety with 59% of the vote was the main business driver for ensuring an effective cold chain. Followed by regulatory compliance 18%, product efficacy 11%, cost of spoilage 7% and only 4% stating brand equity. Opportunities and challenges: The BRIC economies A significant number of the survey respondents – over 41% selected China as the BRIC economy which had the most opportunity for their business. Followed by Brazil and Russia both with 17% and India with 14%

However, China was also identified as the

The Corporate Perspective

The pharmaceutical, biotech and medical device industries are

under increasing pressure to ensure the effectiveness of the

cold chain and demonstrate measureable improvements to

temperature controlled supply chain effectiveness.

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

vote was the main business driver for ensuring an effective cold

chain. Followed by regulatory compliance 18%, product efficacy

11%, cost of spoilage 7% and only 4% stating brand equity.


THE REPORT

Opportunities and challenges:

The BRIC economies: A significant number of the survey

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

which had the most opportunity for their business. Followed by

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

However, China was also identified as the BRIC economy that

participants thought would present the greatest challenge in the

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

Whilst many of these emerging economies have the domestic

growth, many professionals are concerned that they do not yet

have the infrastructure in place to support the logistic challenges

of temperature sensitive storage and distribution.

For many emerging markets improving the existing infrastructure

is of key concern.

Focus on: Emerging Markets

The emerging markets present perhaps the greatest opportunity

and challenges for operating a global temperature controlled

supply chain. Many of these countries economies are still growing

at a healthy, sustainable rate despite the global economic slow

down and are proving to be an attractive global proposition

for pharmaceutical companies looking to increase their global

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.


BRIC economy that participants thought would present the greatest challenge in the next 5 years with 35% of respondents selecting the country.

Whilst many of these emerging economies have the domestic growth, many professionals are concerned that they do not yet have the infrastructure in place to support the logistic challenges of temperature sensitive storage and distribution

For many emerging markets improving the existing infrastructure is of key concern.


Featuring lower down the rank of core priorities where reducing product theft within the distribution chain 7%, the sustainability and environmental impact of the supply chain and moving toward the outsourcing model within the supply chain with just 3%.

The Corporate Perspective The pharmaceutical, biotech and medical device industries are under increasing pressure to ensure the effectiveness the cold chain and demonstrate measureable improvements to temperature controlled supply chain effectiveness. For over half of the respondents, patient safety with 59% of the vote was the main business driver for ensuring an effective cold chain. Followed by regulatory compliance 18%, product efficacy 11%, cost of spoilage 7% and only 4% stating brand equity. Opportunities and challenges: The BRIC economies A significant number of the survey respondents – over 41% selected China as the BRIC economy which had the most opportunity for their business. Followed by Brazil and Russia both with 17% and India with 14%

However, China was also identified as the


COLD CHAIN IQ

Brazil consistently presents an important voice to the world on

behalf of the interests of emerging and developing economies.”

Brazil has recently overtaken the UK to become the sixth-biggest

economy. The economy grew 2.7% last year, official figures show,

more than the UK’s 0.8% growth.

India

Fast-growing economies and large patient pools are

attracting manufacturers to conduct more clinical trials in

emerging markets. In turn this is increasing the demand on

temperaturecontrolled storage and distribution of clinical

supplies in high-growth regions. According to the “BRIC Clinical

Trials Report: Opportunities and Challenges”, India is primed to

become a hub for clinical research and clinical outsourcing

activities, with over 53.5% identifying India as the BRIC country

with the greatest opportunities for clinical trials.

“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.

The key concerns for manufacturers and distributors are

accessibility, visibility and data, local regulations and import and

export issues.

Ray Goff Director, Vaccine Production Pfizer, spoke to Pharma IQ

about increased time spent implementing a clinical supply in the

BRIC countries:



The emerging markets present perhaps the greatest opportunity and challenges for operating a global temperature controlled supply chain. Many of these countries economies are still growing at a healthy, sustainable event despite the global economic slow down and are proving to be an attractive global proposition for pharmaceutical companies looking to increase their global 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 play 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. Brazil consistently presents an important voice to the world on behalf of the interests of emerging and developing economies.”

Brazil has recently overtaken the UK to become the sixth-biggest economy. The economy grew 2.7% last year, official figures show, more than the UK's 0.8% growth.

India Fast-growing economies and large patient pools are attracting manufacturers to conduct more clinical trials in emerging markets. In turn this is increasing the demand on temperature-controlled storage and distribution of clinical supplies in high-growth regions. According to the “BRIC Clinical Trials Report: Opportunities and Challenges”, India is primed to become a hub for clinical research and clinical outsourcing activities, with over 53.5% identifying India as the BRIC country with the greatest opportunities for clinical trials.

“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.

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

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

“In Brazil we are being asked to ensure that everything is monitored and that there is proof of monitoring. In the area of cool chain that’s going to require a little more diligence from us and we are seeing the timeline going much longer and any of the customs or logistics challenges need to be dialled into to all your estimates for supplies. At the same respect if that doesn’t happen, you end up getting more excursions which will require more supplies from you,” he said.

Pharmaceutical companies must assume responsibility for their product quality and safety and therefore need to ensure that the partners they work with in the supply chain comply with not only local but also globally recognised standards.

“In Brazil we are being asked to ensure that everything is

monitored and that there is proof of monitoring. In the area of

cool chain that’s going to require a little more diligence from us

and we are seeing the timeline going much longer and any of the

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

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

you end up getting more excursions which will require more

supplies from you,” he said.

Pharmaceutical companies must assume responsibility for their

product quality and safety and therefore need to ensure that the

partners they work with in the supply chain comply with not only

local but also globally recognised standards.

Russia

According to Frost and Sullivan the Russian pharma market

is expected to be worth $37.15bn in 2016. As the region

prepares for a significant growth phase, the article “Russia:

Needs to Invest in Cold Chain Infrastructure for Biopharma to

Grow” examined the need to capitalise on this interest from big

players within the pharmaceutical by investing in its cold chain

infrastructure – an asset which will become ever more important

as biopharmaceuticals develop.

World Courier last year opened its temperature

controlled distribution centre, boasting “validated

storage areas for investigational drugs, diagnostic

kits and medical devices”, in Moscow. It is just the

seventh such facility the company had opened

worldwide.

Centralised depots can significantly reduce customs

delays and improve regulatory permit process.

“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.

Just over one year later it announced it was

increasing storage capacity at the Moscow facility,

due to high customer demand.

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

Contact: Cool Chain Logistics Team c/o Adrian Rayner　Tel: +44-(0)1784-422-637

[email protected]　www.jal.co.jp/en/jalcargo/

-SOLUTIONS PHARMA

[RELIABILITY]

Constant Temperature Control Dedicated Logistics Team

COOL CHAIN LOGISTICS

Provide the best solution

for the transportation of

pharmaceuticals.


COLD CHAIN IQ

Deputy industry and trade minister Denis Manturov told the

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

of facilities needed to manufacture competitive products in

accordance with international standards.”

Outgoing President Dmitry Medvedev has also previously

declared modernisation of the pharma industry as one of his top

5 priorities.

Pharma IQ looked at how companies specialising in cold chain

facilities for the pharmaceutical industry are now catching on to

the demand for such infrastructure in Russia.

However, results from the Cool Chain Logistics survey

conducted by Pharma IQ in October 2011 revealed that although

authorities are making progress in boosting the appeal of their

pharmaceutical market, not all are yet convinced about the cool

chain infrastructure it has in place.

Some 58% of those polled said they currently 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.

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

percent of those surveyed.

The issue could be connected with the decision by Russia to

favour domestically produced pharmaceuticals over international

imports, which has led to the signing of some lucrative deals.

Other issues raised in the Pharma IQ survey included the lack

of availability of specialised transport, as mentioned by 23.1

percent 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.

The Middle East

Viliam Kovac, Vice President Global Supply Chain Quality, Roche,

spoke to Pharma IQ about reducing supply chain vulnerabilities

and improving distribution operations across the Middle East.

When asked what he thought were the three main challenges with

regards to improving distribution operations across the region, he

identified the cold chain first.

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

profile to implement adequate cold chain management controls,

as a first one; then, having specific and mutually agreed quality

contracts of what need to be done as a second; and, finally, the

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

Mohamed Nasser, Managing Director, Eli Lilly, Saudi Arabia, also

reiterated the significant business impact of the temperature

controlled supply chain and the unique challenges that the Middle

Eastern pharmaceutical market faces, with respect to the cold

chain and temperature controlled distribution:


Russia

According to Frost and Sullivan the Russian pharma market expected to be worth $37.15bn in 2016. As the region prepares for a significant growth phase, the article “Russia: Needs to Invest in Cold Chain Infrastructure for Biopharma to Grow” examined the need for capitalise on this interest from big players within the pharmaceutical by investing in its cold chain infrastructure – an asset which will become ever more important as biopharmaceuticals develop. Deputy industry and trade minister Denis Manturov told the Moscow Times: "There's a lag in the technological development of facilities needed to manufacture competitive products in accordance with international standards." Outgoing President Dmitry Medvedev has also previously declared modernisation of the pharma industry as one of his top 5 priorities. Pharma IQ looked at how companies specialising in cold chain facilities for the pharmaceutical industry are now catching on to the demand for such infrastructure in Russia.

However, results from the Cool Chain Logistics survey conducted by Pharma IQ in October 2011 revealed that although authorities are making progress in boosting the appeal of their pharmaceutical market although not all are yet convinced about the cool chain infrastructure it has in place. Some 58% of those polled said they currently 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.

World Courier last year opened its temperature controlled distribution centre, boasting "validated storage areas for investigational drugs, diagnostic kits and medical devices", in Moscow. It is just the seventh such facility the company had opened worldwide.

Centralised depots can significantly reduce customs delays and improve regulatory permit process.

"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.

Just over one year later it announced it was increasing storage capacity at the Moscow facility, due to high customer demand. Source: Russia: Needs to Invest in Cold Chain Infrastructure for Biopharma to Grow


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 percent of those surveyed.

The issue could be connected with the decision by Russia to favour domestically

produced pharmaceuticals over international imports, which has led to the signing of some lucrative deals.

Other issues raised in the Pharma IQ survey included the lack of availability of specialised transport, as mentioned by 23.1 percent 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.

The Middle East

Viliam Kovac, Vice President Global Supply Chain Quality, Roche, spoke to Pharma IQ about reducing supply chain vulnerabilities and improving distribution operations across the Middle East. When asked what he thought were the three main challenges with regards to improving distribution operations across the region, he identified the cold chain first. “I would say that a creation of a region related temperature profiles to implement adequate cold chain management controls, as a first one; then, having a specific and mutually agreed quality contracts of what need to be done as a second; and, finally, the last piece is the training, so people’s qualifications,” he said. Mohamed Nasser, Managing Director, Eli Lilly, Saudi Arabia, also reiterated the significant business impact of the temperature controlled supply chain and the unique challenges that the Middle Eastern pharmaceutical market faces, with respect to the cold chain and temperature controlled distribution: Nasser said: “The number one challenge we need to watch out 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 about the product quality in different parts of the world, we need to be doubly careful about the quality of our product, post manufacturing, during handling and distribution


THE REPORT

Controlled Room Temperature

Temperature control is a critical part of product integrity,

improper handling especially of temperature-sensitive

pharmaceuticals can compromise the efficacy and safety of drugs

and pose just as serious implications to patients’ safety.

With the number of temperature-sensitive drugs set to rise

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

becoming an important temperature range. Thermal deviations

outside of the CRT envelope can comprise efficacy and patient

safety.

As a result, regulators around the globe are paying closer

attention to temperature controls and data results from

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

changed the industry discussion from coldchain management to

temperature controlled management for all ranges of product

temperature sensitivity.

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%.

Gary Hutchinson, cold chain expert in thermal packaging

engineering and controlled environment logistics for

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

are taking and even internal quality people at each individual

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.

Pharma IQ asked Jim Lucie, Senior Manager for Material Control

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

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

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

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

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

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

manufacturing, during handling and distribution in this part of the

world.”

Nasser also noted distribution to remote areas based on the

existing transportation systems and ensuring a closed chain even

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

One of biggest global challenges today for the pharmaceutical

supply chain is ensuring supply chain integrity.

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

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

distribution challenge is very well closed and very secure against,

or circumvented against counterfeit penetration, is a significant

challenge, and very, very important to make sure that quality

medicine is reaching the patient.”

The Business Perspective: Top Tips for

Developing a Cold Chain in the Middle East

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?

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.

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.

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


COLD CHAIN IQ

shippers, and a little bit closer look at that even from a regulatory

standpoint.”

According to the recent Pharma IQ study, Storage and

Distribution of CRT and Ambient Products conducted earlier this

year, increased regulatory scrutiny is being felt by the industry

with respect to the handling of CRT products in the supply chain.

An overwhelming 81% of respondents think regulators around

the globe are paying closer attention to temperature controls

and results from shipments of controlled room temperature and

ambient products.

Collecting ambient data can be 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

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

small number indicated packaging design at 6% as their greatest

challenge when distributing and storing CRT products and none

identified defining stability profile and understanding regulatory

requirements.

Michael English, Senior Product Engineer of Packaging

Technologies at Merck, also highlighted the increased attention

by the industry on distribution of ambient

and CRT products.

“A lot more questions over the control

of these products are coming up for

transit and there are several attempts to

maintain this tight range especially for

clinical items. I think manufacturers are

better able to demonstrate robustness of

these products for ambient shipping and

should do that,” said English.


According to the recent Pharma IQ study, Storage and Distribution of CRT and Ambient Products conducted earlier this year, increased regulatory scrutiny is being felt by the industry with respect to the handling of CRT products in the supply chain. An overwhelming 81% of respondents think regulators around the globe are paying closer attention to temperature controls and results from shipments of controlled room temperature and ambient products.

Collecting ambient data can be 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 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 small number indicated packaging design at 6% as their greatest challenge when distributing and storing CRT products and none identified defining stability profile and understanding regulatory requirements.

Michael English, Senior Product Engineer of Packaging Technologies at Merck, also highlighted the increased attention by the industry on distribution of ambient and CRT

products.

“A lot more questions over the control of these products are coming up for transit and there are several attempts to maintain this tight range especially for clinical items. I think manufacturers are better able to demonstrate robustness of these products for ambient shipping and should do that,” said English.


According to the recent Pharma IQ study, Storage and Distribution of CRT and Ambient Products conducted earlier this year, increased regulatory scrutiny is being felt by the industry with respect to the handling of CRT products in the supply chain. An overwhelming 81% of respondents think regulators around the globe are paying closer attention to temperature controls and results from shipments of controlled room temperature and ambient products.

Collecting ambient data can be 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 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 small number indicated packaging design at 6% as their greatest challenge when distributing and storing CRT products and none identified defining stability profile and understanding regulatory requirements.

Michael English, Senior Product Engineer of Packaging Technologies at Merck, also highlighted the increased attention by the industry on distribution of ambient and CRT

products.

“A lot more questions over the control of these products are coming up for transit and there are several attempts to maintain this tight range especially for clinical items. I think manufacturers are better able to demonstrate robustness of these products for ambient shipping and should do that,” said English.



Temperature control is a critical part of product integrity improper handling especially of temperature-sensitive pharmaceuticals can compromise the efficacy and safety of drugs and pose just as serious of implications to patients’ safety.

With the number of temperature-sensitive drugs set to rise over the next few years. Controlled Room temperature (CRT) is becoming an important temperature range. Thermal deviations outside of the CRT envelope can comprise efficacy and patient safety.

As a result, regulators around the globe are paying closer attention to temperature controls and data results from shipments of CRT and “ambient” products. This attention has changed the industry discussion from cold-chain management to temperature controlled management for all ranges of product temperature sensitivity. 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%.

Gary Hutchinson, cold chain expert in thermal packaging engineering and controlled environment logistics for 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 are taking and even internal quality people at each individual 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.

Pharma IQ asked Jim Lucie, Senior Manager for Material Control 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 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 shippers, and a little bit closer look at that even from a regulatory standpoint.”


THE REPORT

Implementing a Quality Management System

As reducing the number of excursions and deviations in the

supply chain is a key concern for the majority of temperature

controlled logistics and quality management professionals. The

11th Annual Cool Chain Logistics Europe survey also looked

at the current percentage of excursions and deviations of

temperature sensitive product whilst in the distribution chain.

It found that at least 10% of respondents had recorded a

deviation or excursion in above 15% of their temperature

sensitive product whilst in the distribution chain. One way that

the industry is looking to overcome this challenge is implementing

a quality management system (QMS).

A QMS can be expressed as the organisational structure,

procedures, processes and resources needed to implement

quality management. It encompasses all of the critical control

points in delivering a high quality pharmaceutical customer to the

end customer.

Implementing a QMS involves:

• Understanding the requirements

• Putting procedures in place

• Understanding the risk

• Mitigating risk

Implementation of a sound QMS within the temperature

controlled logistics process is increasingly expected by the

shippers and the regulators.

“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

of a company.”

It is important to understand what a product can handle at each

step to avoid product recalls and adverse reactions.

Quality should be built in from the beginning of the supply chain

from R&D down to delivery to the end user.

Mazur-Melnyk said: “A Quality Management System is key.

We have all heard, quality has to be built in to the process and

product, it can’t be tested in.”

Speaking of the consequences of not following a quality

management system, she said: “You can see a company that has

not followed a quality management system is testing and testing

A GOOD QUALITY MANAGEMENT SYSTEM SHOULD BE IN THE DNA

OF A COMPANY - TONY WRIGHT



As reducing the number of excursions and deviations in the supply chain is a key concern for the majority of temperature controlled logistics and quality management professionals. The 11th Annual Cool Chain Logistics Europe survey also looked at the current percentage of excursions and deviations of temperature sensitive product whilst in the distribution chain. It found that at least 10% of respondents had recorded a deviation or excursion in above 15% of their temperature sensitive product whilst in the distribution chain.

One way that the industry is looking to overcome this challenge is implementing a quality management system (QMS). A QMS can be expressed as the organisational structure, procedures, processes and resources needed to implement quality management. It encompasses all of the critical control points in delivering a high quality pharmaceutical customer to the end customer.

I

Implementing a QMS involves:

Understanding the requirements Putting procedures in place Understanding the risk Mitigating risk

Implementation of a sound QMS within the temperature controlled logistics process is increasingly expected by the shippers and the regulators.

“We have heard that there have been many adverse reactions in 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 of a company.” It is important to understand what a product can handle at each step to avoid product recalls and adverse reactions.

Quality should be built in from the beginning of the supply chain from R&D down to delivery to the end user.

A good Quality Management System should be in the DNA of a

company - Tony Wright


COLD CHAIN IQ

and the costs are increasing and the stability programs are

increasing, product losses are increasing”.

When implementing a QMS one of the key challenges companies

face is how to define their quality management system and

understanding what the mechanism is about.

Wright broke the quality management system down into three

simple principles:

1. Document what you do put on record all the processes and

procedures that are part of your business and your involvement

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

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

more detrimental for a company:

“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.

“I think companies not using a quality management system

will typically be noted for having disjointed and inadequate

procedures. They won’t, for example, have qualified their

equipment to a high standard, and I think one other feature of

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

they do spend a disproportionate amount of their time in the

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

using a quality management approach to take those learnings that

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

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

All stakeholders in the temperature controlled supply chain need

to have quality at their heart to ensure effective temperature

assurance.

Just in Time and Multi-Use Packaging

Time is probably the most critical factor in the distribution of

temperature control clinical supplies.

Running clinical trials effectively can provide a company

competitive advantage and clinical supply professionals have a

unique understanding of just how important it is to ensure timely

dosage of patients and keep to trial timelines.

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:

• 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

Are you running a high QMS out of tolerance fever?

• 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

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”.

(Source: Putting the “Quality” back into Your QMS)


THE REPORT

Dan Holst Jakobsen, Systems Specialist & IT Coordinator and

Abhijit Bendre Business Analyst CMC Clinical Supplies from

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

clinical supply chain of temperature sensitive IMPs and materials

by shortening the lead times between packaging and the patient.

They talked about the advantages of postponing packaging

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

information about demand at hand.

“Just in time printing and packaging would be a great way of

reducing risk because you have less product in the supply chain,”

said Jakobsen.

One of key challenges for temperature controlled clinical supply is

reducing the amount of overages.

There are many challenges the pharmaceutical industry faces in

deploying multi-use packaging solutions for European or Global

distribution.

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

majority of respondents 41% found effective reverse logistics

networks a challenge.

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

reclaim or decontamination standards/methods to satisfy QA

24%, lack of clear ROI models 23%, high initial capital outlay 14%,

import/export issues 8% and lack of rental or leasing options

respectively.

Reverse Logistics

According to Martin Wegner, Vice President of DHL Solutions

and Innovations (DSI), the key drivers for implementing a reusable

shipping system are availability and cost.

An integrated supply chain strategy that incorporates both


Just in Time and Multi-Use Packaging Time is probably the most critical factor in the distribution of temp control clinical supplies. Running clinical trials effectively can provide a company competitive advantage and clinical supply professionals have a unique understanding of just how important it is to ensure timely dosage of patients and keep to trial timelines.

Dan Holst Jakobsen, Systems Specialist & IT Coordinator and Abhijit Bendre Business Analyst CMC Clinical Supplies from Novo Nordisk, spoke to Pharma IQ about reducing risk in the clinical supply chain of temperature sensitive IMPs and materials by shortening the lead times between packaging and the patient.

They talked about the advantages of postponing packaging decisions as much as possible so that we can have more precise information about demand is at hand.

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

One of key challenges for temperature controlled clinical supply is reducing the

amount of overages.

There are many challenges the pharmaceutical industry faces in deploying multi-use packaging solutions for European or Global distribution. In the 11th Annual Cool Chain Logistics Europe survey, the majority of respondents 41% found effective reverse logistics networks a challenge. Followed by asset management and tracking

at 25%, cleaning, reclaim or decontamination standards/methods to satisfy QA 24%, lack of clear ROI models 23%, high initial capital outlay 14%, import/export issues 8% and lack of rental or leasing options respectively.

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

Complete peace of mind for your pharmaceutical and healthcare shipments

[email protected] | www.cargolux.com

Flying with careIt 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 purpose-built 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.

+2°C to +8°C +15°C to +25°C


THE REPORT

forward and reverse logistics becomes increasingly important

in an increasingly globalised and stretched supply chain

management reality. Effective reverse logistics can help

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

manufacturing effort. (Tan, A.W.K. and Hosie, P. 2010) Reverse

logistics is all about setting metrics for cost saving and efficiency-

boosting investments.

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

lower cost than a oneway system.

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

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

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

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

would have to transport them back without any goods inside,

which again increases the cost.”

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

in reusable systems due to cost pressure especially in the

transportation of generics.

“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 based on reusable systems.” he said.

In contrast, some also question whether reverse logistics really

save money, when further validation is always required to ensure

temperature assurance and re-testing of equipment is required to

make sure packaging is still reusable.

Gary Hutchinson, President at Modality Solutions commented: “I

don’t think reusable packaging systems are going to get much of

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

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

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

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

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

inspection or requalification in place to make sure the equipment

that you sent out is still viable.”

It is crucial to build a robust quality assurance process to avoid

costly delays. For all companies their experience of forward

logistics is greater than of their reverse logistics. “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,” said Robert Bronstein,

Director of Clinical Supply Operations, MacroGenics.

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

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

chain is difficult and requires planning for all possible outcomes.

You must always have a plan ready to execute should it become

necessary to reverse the clinical supply chain or recall a product

or component,” Bronstein said.

Bronstein shared an example of one of the processes that

MacroGenics have in place to bring supplies back.

When initiating a site they have the site fill out documentation

with regards to their destruction capabilities. Should anything

negative occur at the site, can they destroy product at the site

or do they need to return? This enables MarcoGenics to plan a

strategy in advance.

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

set for customers and partners and evaluating your outsourcing

partners’ capabilities in reverse logistics.

There will also be an increased demand for visibility and tracking

in transport logistics.

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


COLD CHAIN IQ

Green Initiatives

The pharmaceutical industry like many other industries around

the world is facing pressure from the public and governments to

reduce their environmental impact.

As focus shifts towards reducing carbon emissions, the

pharmaceutical industry finds itself facing a dilemma in

maintaining strict safety standards while improving its

environmental credentials.

In “Cutting Waste in the Cold Chain” Geraint Thomas, Technical

Director at Laminar Medica wrote: “The suppliers and users of

temperature controlled packaging systems are under increasing

pressure to reduce the environmental impact of cold chain

shipping. The widespread introduction of formal corporate social

responsibility policies, together with new customer expectations

and more strict regulations, mean that developing a suitable

packaging system is more challenging than ever.”

But can a resource and energy intensive area like cold chain

ever become truly sustainable?

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

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

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

not viable. This does not represent a lack of commitment to green

issues, but more the challenge of establishing even a basic cold

chain in the first place,” said the IQ.

Thomas explained the importance of considering how your

temperature controlled packing system impacts on the

environment, and suggested approaches for minimising both your

waste and costs.

“While it might seem at first necessary to reduce the amount of

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

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

packaging by 10% means that 10% of the resources needed to

produce the packaging are wasted, and extra fuel will be needed

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

product being spoilt or damaged wastes 100% of the resources

used to produce both the contents and its packaging, and all the

fuel used to distribute it,” he said.

Mark Goh, Director of Industry Research, The Logistics Institute

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

pharmaceutical cold chain, you must first identify the areas where

you can green and which are going to be more amenable.

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

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

astute service providers out there in the market place who are

focusing very strongly on making sure that packaging is reusable

and particularly in the area of secondary packaging.”

Goh commented on the fact that we are already seeing

investment by logistics providers in this area.

“Good service providers in logistics, such as UPS and DHL in fact

have invested good money into this area. One example that UPS

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

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

produce and not really consume directly.”

“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, and that is a good sign,”

he continued.

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

pharmaceutical cold chain can be.

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

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

greener than others. The biggest challenge would be to have

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


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.

The report on the Pharmaceutical Distribution survey examined

the relationship between manufacturers and third party

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

work, with product integrity intact throughout the journey from

lab to end user,” said the report.

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.

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

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.

Building a robust green pharmaceutical cold chain is not

just about the packaging. Installation of renewable energy

technology at the warehouse and utilising alternative fuels during

distribution are also avenues being explored for reducing the

supply chain’s carbon footprint.

This exploration looks set to continue as companies seek to

implement green strategies efficiently and that can ultimately

reduce cost.

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.

Balancing Act

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.

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.

The report on the Pharmaceutical Distribution survey examined the relationship between manufacturers and of third party 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 work, with product integrity intact throughout the journey from lab to end user,” said the report.

Setting the evaluation criteria for new logistics provider 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.

As part of the 11th Annual Cool Chain Logistics Europe survey, participants were asked to identify the most important capabilities they look for when selecting supply chain vendors to work with in your temperature assurance supply chain.

Over half of the respondents, 55% said quality standards. Followed by 26% price advantage, 23% service excellence, 19% innovation and 13% specific expertise to support their business. Therefore it is critical to select a partner who

has as good track record of adhering to quality standards and maintaining supply chain integrity. As the healthcare industry focuses on core competencies, and the supply chain dynamics change, nearly 60% of participants said they were likely to for innovation and influence over their packaging solutions from logistics service providers who can provide full turnkey solutions. Whilst 16% of respondents said they were more likely to look for influence and innovation from their peers and colleagues within the cold chain sector.

Pharmaceutical and biotech companies are taking various steps to improve their service levels in their cold chain supply, from investing in new technology and infrastructure to increasing the number of partnerships with service providers.

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

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


COLD CHAIN IQ

As part of the 11th Annual Cool Chain Logistics Europe

survey, participants were asked to identify the most important

capabilities they look for when selecting supply chain vendors to

work with in your temperature assurance supply chain.

Over half of the respondents, 55% said quality standards.

Followed by 26% price advantage, 23% service excellence, 19%

innovation and 13% specific expertise to support their business.

Therefore it is critical to select a partner who has as good track

record of adhering to quality standards and maintaining supply

chain integrity.

As the healthcare industry focuses on core competencies, and

the supply chain dynamics change, nearly 60% of participants

said they were likely to for innovation and influence over their

packaging solutions from logistics service providers who can

provide full turnkey solutions. Whilst 16% of respondents said

they were more likely to look for influence and innovation from

their peers and colleagues within the cold chain sector.

Pharmaceutical and biotech companies are taking various steps

to improve their service levels in their cold chain supply, from

investing in new technology and infrastructure to increasing the

number of partnerships with service providers.

As part of the Cool Chain Logistics survey, respondents were

asked what they found was the biggest challenge or risk in

establishing a logistics partnership. For 39% of respondents not

having enough control or visibility was the biggest risk. This was

followed by defining responsibilities 23% and subcontracting

to other companies 19%, devising quality agreements 7%

respectively. Merging company cultures was only big risk for

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

temperature control was a core competency of their logistic

service provider.


As part of the Cool Chain Logistics survey, respondents were asked what they found was the biggest challenge or risk in establishing a logistics partnership. For 39% of respondents not having enough control or visibility was the biggest risk. This was followed by defining responsibilities 23% and 3PLs subcontracting to other companies 19%, devising quality agreements 7% respectively. Merging company cultures was only big risk for 4% of respondents. For 96% of respondents, cold chain or temperature control was a core competency of their logistic service provider.




THE REPORT

Summary

In summary a global reach and local 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

[email protected].



New Look, New Format, New Ideas

Sign up Today at www.coldchainiq.com.



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 [email protected].


COLD CHAIN IQ

Acknowledgements

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

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

controlled supply chain participants and stakeholders.

There are too many to mention them all – but everyone who has

taken the time to contribute to our websites or to our events

has shared their expertise and experiences in the storage and

distribution of temperature sensitive pharmaceuticals.

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

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

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

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

Mohamed Nasser, Geraint Thomas, Martin Wegner, Jon Wetzel &

Tony Wright.

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

who took part in our Pharmaceutical Distribution, Cool Chain

Logistics and Storage and Distribution of CRT and Ambient

Products surveys over the course of 2011 and the 11th Annual

Cool Chain Logistics Europe survey this year.

About Cold Chain IQ

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

An international resource centre for the temperature control life

science professional, Cold Chain IQ delivers insightful, unbiased

information about today’s ‘hot topics’.

Members benefit by reading expert analysis, trend-setting

articles, listening to podcast interviews, watching video features

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

supply chain event series.

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.

Appendix


BRIC Clinical Trials Report: Opportunities and Challenges

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

trial-report-clinical-trialsopportu/

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

Clinical Trial Supply Trends and Challenges

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

with-ray-goffdirector- vaccine-produc/

Viliam Kovac: Mitigating Risk in the Global Pharmaceutical

Supply Chain

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

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

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

Impact of Cold Chain Supply

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

mohamed-nasser-md-eli-lillysaudi- arabia-the-busin/


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

Management Systems

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

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

How are Temperature Restrictions for Ambient Temperatures

Affecting Packaging Design?

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

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

Join today for free! www.ColdChainIQ.com



What is a Quality Management System?

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

is-a-qualitymanagement- system/

Tony Wright on The Importance of having a Quality

Management System

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

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

Putting the “Quality” back into Your QMS

http://www.pharma-iq.com/pre-clinicaldiscovery- and-

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

Just in Time and Multi-Use Packaging

Challenges in Cold Chain Logistics and Just in Time Packaging

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

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

Reverse Logistics

REWIND: Reverse Logistics in Clinical Trial Supply

http://www.coldchainiq.com/clinicalsupply/a podcasts/rewind-

reverse-logistics-inclinical- trial-supply/

DHL’s Martin Wegner: Implementing Cost- Effective Reusable

Shipping Systems

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

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

Gary Hutchinson on the Three Rs of Logistics: Reusable, Reverse

& Requalification

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

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

Green Initiatives

Cutting Waste in the Cold Chain - Geraint Thomas, Laminar

Medica

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

cutting-waste-in-thecold- chain/

Can the Cold Chain Ever Become Truly Sustainable?


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

Is Your Pharmaceutical Packaging Solution about to Fail?


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

Finding the Optimal Route for Cold Chain

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

finding-the-optimal-route-forcold- chain/



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 [email protected].

THE REPORT




Air cargo delivering the modern world

The global economy relies on air transport to deliver high

quality products at competitive prices to consumers worldwide.

International trade is now estimated at over USD 15 trillion and

about 35% of that value is transported by air.

With the healthcare market becoming a key engine of the global

economy, pharmaceutical and biomedical industries are facing

new challenges in adapting to globalisation. Air cargo is an

essential link in the consumer supply chain ensuring continual

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

The International Air Transport Association (IATA) is the

industry’s global trade association and represents some 240

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

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

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

benefiting all parties (airlines, forwarders, governments, Customs

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

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

is to foster a safe, secure, reliable, efficient and profitable air

cargo supply chain. Specialist drugs, vaccines and emergency aid

rely on air cargo to get where they are needed.

The market for healthcare products continues to grow and shows

strong resilience to global economic downturns. An increasingly

ageing population requires access to new products and spending

on national healthcare programmes is an important part of many

government social policies. The emergence and expansion of

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

markets will shift demand and lead to more balanced trade flows

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

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

economies are discerning high-end consumers who will continue

to sustain airfreight growth in the years to come.

Understanding customer needs, anticipating them and adding

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

particular the healthcare industry is concerned with ensuring the

integrity of sensitive products is maintained when transported

by air. IATA in collaboration with supply chain stakeholders and

partners has undertaken collaborative actions to address these

concerns.

IATA Standards: Transportation of Time and Temperature Sensitive Products



Speed to market is essential and the healthcare industry is

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

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

component of the industry and is continuously rising in line with

international trade. The most important issue for the industry

and its logistic providers is to clarify mutual expectations to

minimise risks and challenges for airfreight within the cool chain.

Temperature deviations and temperature excursions throughout

the journey requires the establishment of a complete logistical

process to maintain the shipment integrity. Quality, reliability

and performance are crucial, and to achieve this dialogue,

joint strategy and standardisation throughout the complete

supply chain is needed. The shipper is ultimately responsible

for ensuring the product (and any necessary packaging) is

preconditioned to the required temperature, and will remain

within a temperature range for a certain period of time, using

the appropriate refrigeration method adapted to the shipping

circumstances. However the accountability is shared by all of

the stakeholders within the healthcare supply chain. Meeting

the challenges can only be achieved by cooperation between all

stakeholders involved in the supply chain, who recognise the need

for guidelines.

Background

To address the challenges in transporting healthcare products,

IATA established a dedicated working group, the IATA Time and

Temperature Task Force (TTTF) under the supervision of the

IATA Live Animals and Perishables Board, a governance body

Mrs. Andrea Gruber

Manager Cargo Business, Process & Standards

International Air Transport Association

Mrs. Gruber joined the International Air Transport Association

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

Cargo Division and is responsible for delivering the standards and

processes for the air cargo supply chain.

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

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

secretary to the IATA Live Animals and Perishables Board and the

Time and Temperature Task Force.

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

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

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

risk management.

Mrs. Gruber studied in Geneva at the University and at the

Graduate Institute of International Studies (I.U.H.E.I.) and holds a

Master of Sciences in International Relations.




comprised of 12 Airline members, who endorse the healthcare

standards for the air cargo industry recommended by the Time

and Temperature Task Force members.

The work undertaken by this healthcare industry, subject matter

expert Task Force (composed of airlines, ground handling

agents, freight forwarders, shippers, international and national

organisations, airports, and equipment manufacturers) led to

the inclusion of a specific chapter in the existing IATA Perishable

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

the IATA PCR as the essential reference guide for all parties

involved in the packaging and handling and distribution by air

of time & temperature sensitive healthcare products. Chapter

17 “Air Transport Logistics for Time and Temperature Sensitive

Healthcare Products” in the PCR specifically addresses the

temperature control management issues identified by the

industry and sets out recommended standards such as the use

of the IATA Time and Temperature Sensitive label, developed

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

July 1st, 2010.

Mandatory Shipping Label

The Time and Temperature Sensitive label came about as a result

of standardising the nearly endless parade of labels applied by

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

to the healthcare industry, which must be affixed to shipments

transported as time and temperature sensitive cargo. Regarded

as a recommendation, the air cargo industry recognises this label

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

Time and Temperature Sensitive label became mandatory for

the transportation of healthcare cargo shipments transported

as temperature sensitive cargo. The decision to implement this

step resulted from a collective recommendation supported by the

Time and Temperature Task Force and Working Group members

and endorsed by the IATA Live Animals and Perishables Board.

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

sensitive healthcare cargo shipments and that the air cargo supply

chain is prepared to handle the demands of these healthcare

shipments. The application of this new requirement will enhance

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

booked as such, rests with the shipper (or designated shipper’s

agent by service agreement). Though transportation

begins with the shipper, IATA,

*(The temperature indicated on the lower

half of the label must match the approved

transportation temperature range, e.g.

+15ºC to +25ºC)

David Brennan

Assistant Director Cargo Safety & Standards

International Air Transport Association

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

Technical Services. In April 2004 David was appointed Assistant

Director Cargo Safety & Standards.

David 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. David is the Secretary of the IATA Dangerous

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

the International Civil Aviation Organization (ICAO) Dangerous

Goods Panel.

Before joining IATA David worked for Australia Post as a consultant

on Aviation Security / Dangerous Goods compliance. Prior to that

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

a number of supervisory and management positions within the

Operations Division, the last being Corporate Advisor Dangerous

Goods Compliance.



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

booking, which is the key step to successful cargo transportation

and which triggers the appropriate handling and operational

processes associated with healthcare transport. The label only

supports the booking, thus the transportation temperature range

specified on the label must match the transportation temperature

range stated on the Air Waybill, Service Level Agreement (SLA) or

Standard Operating Procedures (SOP).

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

telephone number of a person knowledgeable about the shipment

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

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

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

shipment that may impact on the viability of the contents of the

shipment. More information can be accessed on the IATA website

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

Pages/perishables.aspx

Monitoring devices

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

working on a number of other projects to help tackle difficulties

in pharmaceutical transportation. IATA by means of an industry

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

be focusing on temperature monitoring devices and their use, as

currently there are no clearly defined standards that exist that

permit the use of electrically active devices in cargo shipments.

The healthcare industry is increasingly using monitoring systems,

which may be placed in individual packages, to track temperature

or other parameters through the whole distribution chain. These

track and trace devices, such as electronic temperature data

loggers, are used on or in passive packages but different types of

active containers with advanced monitoring and tracing devices

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

Global Positioning System (GPS) systems raise security concerns

and also issues with the potential interference with aircraft

navigation and electrical systems.

In addition, it is critical to understand that most temperature

monitoring devices contain lithium batteries (commonly lithium

metal batteries), which are dangerous goods. Lithium batteries

represent a significant safety concern.

Incorrectly

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

transport. All lithium batteries must be transported in accordance

with the provisions set out in the IATA Dangerous Goods

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

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

iata.org/lithiumbatteries

Additionally, active devices must comply with the appropriate

airworthiness standards regarding electromagnetic interference

of aircraft systems. The responsibility to comply with these

requirements is with the shippers of such devices. To determine

the requirements, shippers are advised to make contact in

advance with the applicable airline to determine the suitability of

including such active devices in shipments.

Training

Supply chain excellence is achieved as a result of applying

fundamental principles that answer customers’ needs. Training

therefore becomes paramount. Training of staff handling

sensitive cargo is crucial to ensure the integrity of the cold

chain is maintained. For the stakeholders involved in Time

and Temperature Management, it is a prerequisite for the

implementation of the PCR and the air transport logistics of

healthcare products. The success of a programme like Chapter

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

each member of the supply chain understands what their specific

requirements for compliance are, as well as those of others in the

supply chain. This allows for greater understanding of the entire

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

Training and Development Institute leads training in time and

temperature sensitive cargo handling to ensure compliance with

the Perishable Cargo Regulation Chapter 17.

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

therefore such initiatives are carried out in cooperation with the

appropriate cold chain stakeholders in the healthcare industry.

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

the standards to reinforce IATA’s vision for a safe, secure and

profitable air transport industry that sustainably connects and

enriches our world.

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Head of Supply Chain

Head of Commercial

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Head of Networking & Routes

Chairman/CEO

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Track & Trace: Nothing is Impossible

An interview with Taha YayciInterview conducted by

Andrea Charles, Editor, Cold Chain IQ



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.

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

chain. Our observations on the supply chain showed that,

some manufacturers suffered from fraud sale reports by their

own representatives. iTS helped them to detect such kinds of

deceitfulness.

Finally, serialization with tracking and tracing of the serial

numbers in each transaction of the products comes with valuable

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

produce more accurate results about the market demand, stock

and production predictions. In conclusion, serialization may seem

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

cover this cost within a few years.

Turkey leads the way in serialization, but how have the

country’s requirements evolved in recent years?

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

stakeholders, including manufacturers, wholesalers, pharmacists,

hospital administrators and reimbursement companies. In the

development process of the system, we have held many meetings

and workshops to identify the requirements, expectations and

problems of stakeholders. Then, we quickly analyzed these

problems and responded to them as soon as possible.

Furthermore, we have monitored the system to decide how we

could evolve it further as well as how stakeholders have reacted

to the regulative and operational changes. It was observed

that stakeholders each have a different business logic and

requirements; therefore, we evaluated each of them separately.

Dividing the implementation into phases caused stakeholders

to adapt to the system faster. At the end, manufacturers were

demanding and expecting new features and modules, instead of

rejecting them. The main agenda of the meetings were changed

from the problems of stakeholders to their demands.

In your opinion, what is the main operational challenge

manufacturers face in implementation?

I think the most important challenge which manufacturers faced

was to adapt their production lines as well as their business

logic to the requirements of the system. The system put an extra

layer to the operation of production and product transportation

between manufacturers and wholesalers.

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

was omitted by some manufacturers to simplify this operation.

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

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

omit sending sales notifications.

Therefore, those manufacturers faced an important re-

aggregation problem. After such a problem emerged, we provided

professional help and included new features to the system to ease

their operation.

“ 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.

”




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?

Our observation on the Turkish supply chain showed that, data

collected from the transactions of the products could be used to

evaluate the supply chain. The data itself is very promising in Big

Data applications for administrative and commercial purposes.

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

the manufacturer is still a major research field. Our analysis

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

manufacturers, but also every stakeholder including pharmacists

have a valuable data set for its current stock as well as its sales

and receipts. Keeping this data private and utilizing it primarily

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

Moreover, we have used the data for predicting drug shortages

and detecting black markets all over the country at the

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

purpose of the system is only to prevent counterfeit drugs and

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

possible to collect without serialization.

“ MOREOVER, WE HAVE USED

THE DATA FOR PREDICTING

DRUG SHORTAGES AND

DETECTING BLACK MARKETS

ALL OVER THE COUNTRY AT

THE ADMINISTRATIVE STAGE.

”



IATA - DGR54 - Stay Compliant (V7) / The Logistics Portal Jan 2013

full page trim size 210 X 297 mm / safety area 186 X 273 mm

iata.org/dgr

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 fi ned 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.

Stay Compliant

DDIA00122_DGRad_TheLogisticsPortal_V7.indd 1 2013-01-18 11:31 AM

//EVENTSCLINICAL 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



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

EUROPE Softbox Systems Ltd.Units 1-2 RidgewayDrakes DriveLong Crendon Buckinghamshire HP18 9BFUKT: +44 1844 203 560F: +44 1844 203 570E: [email protected]

AMERICASSoftbox Systems Inc.1160 NW Elliot CourtBend, Oregon 97701USAT: +1 541 389 9183F: +1 888 610 0750E: [email protected]

INDIASoftbox Systems India Pvt Ltd.Survey No. 146-148, Village Ajivali, Kon, Old Pune Highway NH-4, Taluka Panvel, District Raigad, Maharashtra 410206T: +91 2232 222 380F: +91 2143 221 789E: [email protected]

ASIA PACIFICSoftbox Temperature Control Packaging Systems Pte. Ltd.48 Toh Guan Road East#02-115 Enterprise HubSingapore 608586T: +65 6316 9584F: +65 6316 9504E: [email protected]

• 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

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Reduce costs and maintain “Label Claim” temperature for shipping pharmaceuticals

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Protecting your pharmaceuticals whatever their destination

www.softboxsystems.com




Environmental Monitoring

Cold Chain IQ columnist Dr. Spiggelkötter

started her career at a pharmaceutical contract

manufacturer where she was responsible for the

sourcing of active pharmaceutical ingredients

in China and India. In this period she audited

suppliers in Asia and she became experienced

in international supplier qualification. Then she

worked for an international consulting company

focusing on audits, inspections, training and

quality control.

Since 2009 Dr. Spiggelkötter has been self-employed,

working in Pharma consulting (special focus supply

chain, transport & storage), risk management,

giving lectures, staff training and auditing services.

Frequently invited as a speaker at conferences,

as a Visiting Professor she gives lectures on

pharmalogistics and is a contributor to publications

on GDP, risk management, transportation and

qualification. Member of an Advisory Board to

medium-sized companies she helps them to get

through the GMP-regulated world.

How to interpret temperature data:

The story behind the Graphs

Temperature monitoring devices are a key device,

to provide valid data that the temperature has

been maintained within a given corridor during

transportation. Regardless of what kind of data

loggers are used, the obtained reports lead often to

broad discussions among the parties involved. In case

of deviations, temperature excursions, a root cause

analysis has to be initiated.

The misinterpretation of temperature data is

frequent, as the correct understanding requires a

deep knowledge in particular of the measurement

locations and tools and measurement. Many causes

can lead to temperature excursions. Here is a

summary of the most prominent facts:

Placement of the loggers

• Close to cooling units / to cooling elements: low

temperature will be displayed

• Close to doors / edges: high temperature will be

displayed

Article By Dr Nicola Spiggelkötter

www.the-logistics-portal.com TLPINSIGHT


45.

• No stable/fixed location: due to vibration or

other physical impact the position might vary

• Has the location been previously proved by

qualification runs? Does it correspond to the

cold and hot spot?

Preconditioning loading area (active cooling

systems)

• Is the temperature in the loading area the

required temperature when the cargo is loaded?

• Does the temperature remain within the

corridor when goods are loaded with open

doors?

• Is the set point of the cooling unit correct?

Preconditioning loads

• Is the entire cargo correctly conditioned when

loaded?

Stowage methods

• Can the air freely circulate within the cargo

department?

• Are areas with “no load” respected?

• Does the cargo have no direct contact with

inner walls?

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 recording interval /frequency correct?

• Is the logger turned on?

• Is the battery working properly?

• Is there enough memory capacity for the data?

• Is the calibration of the logger valid?

• Has the logger correctly been turned off on

arrival of goods at destination?

Temperature deviations are critical, but not all of

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

detect the causes, to understand the story behind

it. This questionnaire might be helpful to detect

them and finally avoid them. Training is essential,

training on “what might go wrong” and how to handle

temperature excursions.




//INDEX OF ADVERTISERS

IFC

5

7

11

16

23

31

38

41

43

IBC

OBC

CSAFE

Sofrigram

Biotec

Berlinger &Co AG

Japan Airlines

Cargolux

TLP Insight

Gooey

IATA

Softbox

DGM

UPS

FOR ADVERTISING INFORMATION CONTACT:

Sales: [email protected]

Subscription: [email protected]

Dangerous Goods Management is all about

safety and minimizing risk. In air transpor tation,

staying compliant with all of the many rules

and regulations is not an easy task. However,

supported by DGOffi ce.net with its specifi c

modules for air transportation, it becomes a

clean cut operation. From Packing Instructions

to Shipper’s Declaration and ‘NOtifi cation TO

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

Safety fi rstin Dangerous Goods Management

DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790,[email protected], www.dgoffi ce.net

automated where possible to save you time

and to reduce error rate to a minimum.

DGOffi ce.net was developed as an on-line

application, meaning you can access it anytime

from anywhere in the world. Alternatively,

run it as you see fi t: within your own network

or on a stand-alone computer.

014016_DGOffice_adv_203x280.indd 2 11-12-12 16:56


Dangerous Goods Management is all about

safety and minimizing risk. In air transpor tation,

staying compliant with all of the many rules

and regulations is not an easy task. However,

supported by DGOffi ce.net with its specifi c

modules for air transportation, it becomes a

clean cut operation. From Packing Instructions

to Shipper’s Declaration and ‘NOtifi cation TO

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

Safety fi rstin Dangerous Goods Management

DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790,[email protected], www.dgoffi ce.net

automated where possible to save you time

and to reduce error rate to a minimum.

DGOffi ce.net was developed as an on-line

application, meaning you can access it anytime

from anywhere in the world. Alternatively,

run it as you see fi t: within your own network

or on a stand-alone computer.

014016_DGOffice_adv_203x280.indd 2 11-12-12 16:56

tlp insight issue 6

Documents

temperature accuracy

internal temperature

temperaturesensitive

temperature control

individual shipment

intensive media

calibrated source data

active aircraft container