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THE LOGISTICS PORTAL MAGAZINE
TLPINSIGHTIssue 6 - 2014
THE LOGISTICS PORTAL MAGAZINE
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
THE LOGISTICS PORTAL MAGAZINE
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
Whi
te P
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.
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
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.
THE LOGISTICS PORTAL MAGAZINE
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
TLPINSIGHT www.the-logistics-portal.com6.
THE LOGISTICS PORTAL MAGAZINE
WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014TLP
//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
THE LOGISTICS PORTAL MAGAZINE
1003-Biotec-EPC-advert.indd 1 24/10/2011 11:33
Biotec Services International LtdBiotec House, Central Park, Western Avenue, Bridgend Industrial Estate, Bridgend, CF31 3RT, UK
Biotec Trusted Globally To DeliverHigh Quality Clinical Supplies ServicesBiotec has established itself as a truly international trusted partner delivering clinical supplies services.
Biotec have built a global reputation as a company with the commitment to quality and technical excellence, the accredited expertise and the in-depth experience needed to take your clinical trials from Phase I to Phase IV and onto commercial supply.
Our services include:
TLPINSIGHT www.the-logistics-portal.com8.
THE LOGISTICS PORTAL MAGAZINE
WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014TLP
Reliance Dependson Preventative Maintenance
Whi
te P
aper
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
CSafe®, AcuTemp®, ThermoCor®, The Right Temperature® and Peace of Mind® are registered trademarks of CSafe Global. © 2014 CSafe Global.
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.
With at least one company you can!
For more information on the CSafe air cargo container
please visit our website www.CSafeGlobal.com
The word ‘rely’ has come to mean a great deal in terms of end-to-end temperature assurance.
Whi
te P
aper
Reliance Dependson Preventative Maintenance
Whi
te P
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.
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
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.
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
THE LOGISTICS PORTAL MAGAZINE
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Unbenannt-1 1 26.02.2014 14:54:14
TLPINSIGHT www.the-logistics-portal.com12.
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.
www.the-logistics-portal.com TLPINSIGHT 13.
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.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 5
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.
TLPINSIGHT www.the-logistics-portal.com14.
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.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 6
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.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 5
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
www.the-logistics-portal.com TLPINSIGHT 15.
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:
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 7
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 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.
www.the-logistics-portal.com TLPINSIGHT 17.
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:
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 8
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
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 9
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
TLPINSIGHT www.the-logistics-portal.com18.
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)
www.the-logistics-portal.com TLPINSIGHT 19.
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.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 12
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 time- consuming 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.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 12
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 time- consuming 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.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 11
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 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.”
TLPINSIGHT www.the-logistics-portal.com20.
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
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 13
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.
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
www.the-logistics-portal.com TLPINSIGHT 21.
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)
TLPINSIGHT www.the-logistics-portal.com22.
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
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 16
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
TLPINSIGHT www.the-logistics-portal.com24.
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
www.the-logistics-portal.com TLPINSIGHT 25.
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
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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)
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 21
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
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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.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 22
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.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 22
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.
TLPINSIGHT www.the-logistics-portal.com28.
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
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 22
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.
New Look, New Format, New Ideas
Sign up Today at www.coldchainiq.com.
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 24
Interested in Finding Out More?
New Look, New Format, New Ideas -‐ Sign up Today at www.coldchainiq.com. The ideas presented in the white paper will be discussed in further detail at our Global Series of Cold Chain and Temperature Controlled Distribution events. Hear from leading experts as to how they are ensuring the integrity of their temperature controlled logistics. To find our more or to sign up for an event, please visit www.coldchainiq.com or contact our customer services team on [email protected].
www.the-logistics-portal.com TLPINSIGHT 29.
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
Focus on: Emerging Markets
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/
Controlled Room Temperature
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
TLPINSIGHT www.the-logistics-portal.com30.
Implementing a Quality Management System
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?
http://www.coldchainiq.com/packagingshipping- systems/articles/
can-the-cold-chainever- become-truly-sustainable/
Is Your Pharmaceutical Packaging Solution about to Fail?
http://www.coldchainiq.com/packagingshipping- systems/articles/
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/
Cold Chain IQ- The Global Network for Temperature Controlled Logistics and Quality www.coldchainiq.com Page 24
Interested in Finding Out More?
New Look, New Format, New Ideas -‐ Sign up Today at www.coldchainiq.com. The ideas presented in the white paper will be discussed in further detail at our Global Series of Cold Chain and Temperature Controlled Distribution events. Hear from leading experts as to how they are ensuring the integrity of their temperature controlled logistics. To find our more or to sign up for an event, please visit www.coldchainiq.com or contact our customer services team on [email protected].
THE REPORT
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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
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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.
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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.
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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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To Request a Brochure, contact-
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m Bikhazi, MD: “we are pushing at an open door with this one”
Speaking on the occasion, Bessem Bikhazi, Managing Director, Gooey UK Ltd; said, "We are re-launching Gooey Data with a clear objective of facilitating database services at one place”. With the philosophy of “Buy, Append or let us arrange data for you”, the new division will be the one stop solution for all data related services that aviation-related companies usually require for their direct networking and other objectives. “Gooey, which is a pioneer company in Air Transport Information management globally has to become a huge success since its inception back in 2010 and is way ahead of its time in its alliances with companies that supports this venture. With our new-style contact databases, we hope to serve the industry in the same dedicated way with an exuded excellence and customized efforts to simplify things for marketers”, adds the director of Data, John Devos. Gooey was founded in 2010 with a unique concept of Aviation Information and Database marketing and has not looked back since. Gooey has lead its way to providing unmatched services in the global market roping in strong partnership and subscribers everywhere. Services of Gooey includes gaining direct access to key contacts on a platform similar to a Spreadsheet but smarter! With numerous clients from airlines, airports, airport authorities, handling agents, industry suppliers, organisations and association and conference/tradeshow organisers. Industry players are very much in favour of this venture, remarks Bessem. “we are pushing at an open door with this one and we’ll be global very soon.”
“WE ARE PUSHING AT AN OPEN DOOR WITH THIS ONE AND WE’LL BE GLOBAL VERY SOON.”
‘’Our mission is to help aviation professionals help themselves by simplifying
processes while reducing costs and improving
THE LOGISTICS PORTAL MAGAZINE
Gain access to world airlines, airports & handlers direct key contacts!Gooey has spent the last few years developing the most powerful communication tool that allows aviation professionals to reach key decision makers faster than ever before.
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direct networkinG:
Head of Business
DevelopmentExecutive VP/Deputy CEO Head of
Strategy & Planning
Quality & Risk Assessment
Head of Ground Operations
Head of Safety/Security
Head of Sales/Communication
Head of Supply Chain
Head of Commercial
Services
Head of Networking & Routes
Chairman/CEO
Head of Flight Operations
Head of I.T
Head of MRO
Head of HR
CFO
Head of Inflight
Head of Technical
COO
TLPINSIGHT www.the-logistics-portal.com38.
THE LOGISTICS PORTAL MAGAZINE
WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014TLP
Track & Trace: Nothing is Impossible
An interview with Taha YayciInterview conducted by
Andrea Charles, Editor, Cold Chain IQ
www.the-logistics-portal.com TLPINSIGHT 39.
Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM TLPTHE LOGISTICS PORTAL MAGAZINE
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.
”
TLPINSIGHT www.the-logistics-portal.com40.
THE LOGISTICS PORTAL MAGAZINE
WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014TLP
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.
”
www.the-logistics-portal.com TLPINSIGHT 41.
Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM TLPTHE LOGISTICS PORTAL MAGAZINE
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
www.the-logistics-portal.com TLPINSIGHT 43.
Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM TLPTHE LOGISTICS PORTAL MAGAZINE
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
• Manufactured from 100% recyclable materials
Reduce costs and maintain “Label Claim” temperature for shipping pharmaceuticals
1. Euro & US Pallet Versions2. UV reflective waterproof cover3. Five Euro systems on air pallet 4. Insulated Pallet Base
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Protecting your pharmaceuticals whatever their destination
www.softboxsystems.com
TLPINSIGHT www.the-logistics-portal.com44.
THE LOGISTICS PORTAL MAGAZINE
WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014TLP
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
Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM TLPTHE LOGISTICS PORTAL MAGAZINE
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.
TLPINSIGHT www.the-logistics-portal.com46.
THE LOGISTICS PORTAL MAGAZINE
WWW.THE-LOGISTICS-PORTAL.COM Issue 06 - 2014TLP
//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]
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safety and minimizing risk. In air transpor tation,
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and regulations is not an easy task. However,
supported by DGOffi ce.net with its specifi c
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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
Issue 06 - 2014 WWW.THE-LOGISTICS-PORTAL.COM TLPTHE LOGISTICS PORTAL MAGAZINE
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