www.globalpharmasupplychain.com

integrity

GDP

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temperature control

Pharma Supply Chain 360

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Contentsv Foreword v A Message From Simon White, Pfizer Global Supply

v Making Money out of Pharma Supply Chains

v Above Market Planning: Always the Right Answer?

v From Supply Chain to Value Chain: The Leadership Challenge

v Supply Chain Integrity • Supply Chain Visibility is a Key Part of Delivering Proof of Product Integrity • Building and Maintaining Integrity is the Number One Supply Chain Priorityv Good Distribution Practice • Top Tips for an EU GDP Inspection • GDP - A Regulatory Perspective from Felix Patzak, Austrian Medicines & Medical Devices Agency • A One Page Guide to Global GDP Guidelines • GDP Goes Internationalv Temperature Controlled Logistics

• Taking a New Approach: Pfizer’s Graham Martin on the Benefits & Lessons Learnt from Developing a Geographical Zoning Approach • Operating a Temperature Controlled Supply Chain - Market Insights • A Generics Perspective: Teva Europe’s Head of Quality Assurance EU Logistics on the Cold Chain Industry • 8 Steps to Implementing a Controlled Room Temperature Strategy

v Security • TAPA EMEA’s Chairman on Solutions to Improve Supply Chain Security & Data Collection in 2014 • Eric Newman VP for Loss Prevention on Effective Risk Management • Protecting Proprietary Information & Ensuring Supply Chain IntegrityRisk Managementv About the 14th Annual Cool Chain & Controlled Room Temperature Logistics Europe v About Cold Chain IQ

How do you ensure you have a successful end-to-end supply chain?

FOREWORD

The global pharmaceutical industry has witnessed significant change in recent years, competition is fiercer than ever and an efficient, quality supply chain is one way to gain and maintain a strategic advantage.

The global nature of the pharmaceutical supply chain makes it highly susceptible to a number of risks from internal and external factors. As supply chain complexity increases, companies must be prepared to overcome the growing challenges of maintaining supply chain integrity, ensuring product security and regulatory compliance.

Facing a ticking clock of temperature sensitive cargo and strict regulations, ensuring end-to-end supply chain effectiveness is of paramount concern. Ahead of the 14th Annual Cool Chain & Controlled Room Temperature Logistics Europe, taking place the 27th – 28th January in Geneva, Switzerland, Cold Chain IQ has complied the Pharma Supply Chain 360 eBook.

This new eBook contains industry insights, surveys and interviews addressing the 4 key global pharmaceutical supply chain challenges of supply chain integrity, good distribution practice (GDP), temperature controlled logistics and security.

We hope you enjoy reading!

Best regards

The Global Pharmaceutical Supply Chain Forumwww.coolchaineurope.com

STAYING CONNECTED

Keep up to date with the latest Cold Chain News

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A Message from Simon White, Pfizer Global Supply

Supply of medicines from manufacturing sites to the patient has grown increasingly complex as the pharmaceutical industry has globalized over past decades. Recent advances welcomed by industry have included the increased regulatory focus on ensuring integrity in the supply chain. This is being achieved through development and revision of regulations for Good Distribution Practice and ideally, in the not too distant future, global harmonization of these requirements. This is in the best interests of the manufacturer, the Marketing Authorization Holder, the health care professional and the patient. More robust expectations in distribution, not only for finished product but also for APIs and excipients, are integral to ensuring that safe medicines reach patients. This applies equally to multinational manufacturers and ‘last mile’ wholesalers and pharmacies, and is part of the combat to the threat to public health caused by falsified and counterfeit medicines, theft and diversion, or the operations of unauthorized suppliers. A balance between cost of distribution processes and uninterrupted product availability in a global context, without compromise to product integrity and quality, is the continuous challenge facing pharmaceutical supply.In the interpretation and practical application of GDP regulations, the importance of data-based risk assessment and decision making, is an essential part of ensuring the right outcome: availability to patients of safe life-enhancing and life-saving medicines.I’m excited about the opportunity presented by the IQPC 14th Annual Cool Chain & Controlled Room Temperature Logistics Europe event in January 2015 to bring regulators, industry and logistics service providers together to enhance mutual understanding of expectations.Best regards

Simon WhiteRegional Leader, Quality Operations Europe, Middle-East & AfricaGlobal Supply ChainPfizer Global Supply

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Making Money out of Pharma Supply Chains

By Richard Powell, Managing Director of Crimson & CoPharma supply chains can be complex and highly regulated, and this leaves plenty of opportunity to gain advantage over competitors and raise the share price, as Richard Powell, Managing Director of Crimson & Co, points out.

Pharma supply chains are different from those in other sectors, says the conventional wisdom. But are they really that different? Having worked in pharma and beyond, the reality is that the biggest winners are often those who recognise that a combination of supply chains are needed to meet their business needs, and each one has parallels and lessons for best practice in other sectors.

Before looking at the solutions, it is worth reflecting on some of the things that make pharma a challenging place.

The first is the need to increase reach to the 80% of the world population that are not buyers from ‘Big Pharma’. This is partly about building the service models (physical logistics, payments systems, customer touch points) to reach these customers, taking the fragile products into increasingly challenging environments. It is also about building the supply chain capabilities to challenge the generic producers and even the consumer goods-style pharma businesses. Pharma companies are going to be fighting on a wider battlefield and have a lot of handicaps to overcome.

Secondly, there is a need to operate effectively in a highly regulated environment, which drives towards remote planning and direction. This often results in operating sites’ challenges not being properly understood and poor plans being produced, and this drives sites to fatalistic “can’t do anything” attitudes. This can undermine performance improvement efforts.

Third, there is often a lack of challenge to some regulation. The sector has to abide by formal licence requirements, and everyone struggles with endmarkets and the customer’s often quite arbitrary requirements. The mindset that goes with these requirements results in a relentless tendency to introduce more standard operating procedures to cover oneoff and, in some cases, entirely theoretical risks; these are easy to introduce and hardly ever reviewed. More needs to be done to make sure practices stay relevant and deliver the real needs of patients, licencing authorities and customers. Few pharmaceutical companies realise how much these ways of working drive the high cost bases that make it very difficult to compete with emerging competitors.’

First published:http://edition.pagesuite-professional.co.uk/launch.aspx?pbid=79b5462b-1224-4a69-92ac-dfe58c916653

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Above Market Planning: Always the Right Answer?

By Dave Alberts, Director, Crimson & CoPharma supply chains can be complex and highly regulated, and this leaves plenty of opportunity to gain advantage over competitors and raise the share price, as Richard Powell, Managing Director of Crimson & Co, points out.

Above Market Planning, which centralises aspects of planning across markets, has been implemented in some form or another by almost every global pharmaceutical business where it has any application.

The drive for tax benefits, supply chain efficiency and the need to deploy skilled resources has driven varying degrees of centralisation. And the resultant organisational disruption and high one off costs have been viewed as a price worth paying. However, the level of standardisation required to make this work is becoming increasingly at odds with the growing complexity of what’s happening out in the end markets. As pharmaceutical markets become more demanding, servicing new geographies to new customers in new ways, is this approach still appropriate? Or should we be challenging ourselves to think about how to adopt a more subtle approach to centralisation without sacrificing customer intimacy in the pursuit of supply chain efficiencies?

Above Market Planning is simple in concept and involves a single point of decision making, either centrally, regionally or a combination of both. It has been adopted by many global organisations to meet a variety of different requirements such as optimising multinational planning decisions concentrating scarce skills tax efficiencies leveraging benefits from low cost locations using supply chain management to extend channels and the services to customers.

First published: http://www.crimsonandco.com/wp-content/uploads/2014/02/Crimson-Co_-Pharma-Mag-Above-Market-Planning.pdf

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From Supply Chain to Value Chain: The Leadership Challenge

By Steve Crom, Partner at Valeocon In difficult economic times there is a necessity to squeeze cost out of supply chains; and, it is an opportunity to create value chains that deliver exceptional value from customer to suppliers. It is at the ends of the supply chain that more and more value is created. Innovative value propositions pull services and products to meet the needs of specific customer segments. Supplier partners delivery capabilities in addition to products in services in line with those value propositions. It is the marketing and sales perspective that enables the shift from supply to value chains.

The Traditional View of Supply Chains

Traditionally supply chains are associated with costs to be minimised: production costs, quality costs, inventories, distribution and logistics costs. Without negatively impacting on service, the objective has been to continuously reduce the cost of goods sold (COGS). Enlightened companies have expanded the objective to minimising the cost of ownership, which includes inventory related costs and warranty costs related to quality. This has drawn attention to supplier management and development to improve supplier quality and reduce raw material and component inventories. Important achievements in reducing overall supply chain cost have been achieved. Taking a Value Perspective

Companies able to grow the top line with supply chain services that add value have changed the equation from minimising cost to maximising value. Examples include:

• Packaging materials suppliers who improve the productivity of packaging lines

• Pharma companies partnering with logistics providers to replenish patient’s supply of medication and adherence to their prescriptions

• Medical device companies increasing access for patients in developing countries by partnering with health care providers

• Car rental companies able to offer one hour usage and distributed access to vehicles

Progressive companies are inverting the deployment of resources to where it can add the most value, at the supplier and customer end of the value chain. The business case for a progressive view of value chain depends on linking supply chains to value propositions. This means marketing and sales leaders at the table with

their operations, supply chain and procurement colleagues defining unmet needs in the market place and developing innovative ways to fulfil them.

One Size Does Not Fit All

Values chains aligned to value propositions and specific customer segments means multiple value chains will run through a company’s production sites and logistics systems. Operational Excellence pays off in that it reduces internal waste, makes processes leaner, more visible and easier to manage. By reducing internal complexity and cost, more value-added complexity can be shifted to the front and back end of value chains.

A Cultural of Collaboration is Key

For many companies focused narrowly on squeezing the purchase price of raw materials/services and conversion costs, the shift to value chains requires a fundamental shift in culture: from raw competition to results through collaboration. The first step is to establish a value-based vision that is shared by the senior leadership team that represents all the functions in the supply chain enterprise including critical support functions such as finance, human resources, communications and the legal department.

Conclusion

A narrow focus on reducing supply chain cost of goods sold should be broadened to maximising value delivered. The shift hinges on linking supply chains to value propositions. Marketing and sales leaders with their supply chain colleagues have an opportunity to develop innovative business models. It starts with a shared, cross-functional vision of what is possible. Because of the cultural shift this requires in most companies, the journey has to start at the top.

Supply Chain Integrity Supply Chain Visibility is a Key Part of Delivering

Proof of Product Integrity

The importance of supply chain visibility has particularly grown, and in the broader debate in confidence in ERP systems to provide appropriate supply chain visibility, it is probably not being addressed that well – according to this article in Forbes magazine, “Building The Extended Supply Chain: If Only It was Like Legos”. This suggests that most companies are pouring money into ERP architectures believing that it can be as easy as connecting one ERP to their own ERP, but it is not as easy as that; today, only one out of four companies are confident that the ERP logic is equal to the task of delivering supply chain visibility to third-party logistics providers, contract manufacturers and first and second tier suppliers.

The debate is also around big data – and why it is important in the movement of temperature-sensitive products both in terms of visibility as well as the ability to take remedial action. For example, the data can tell you instantly if something is wrong in the supply chain, if a temperature excursion has occurred. With relevant experience of knowing what to do with that data and how to interpret it, the supply chain manager is better informed. In addition to making available instantaneous real-time data, the data recording and analytics also enables the generation of relevant data for GDP and HACCP compliance reporting.

The other big trend for 2014 is the internet of things, or the connections of all kinds of devices and objects using radio connections. This is enabling machine to machine, or M2M, communications and allowing suppliers to the pharmaceutical and food industries to provide more data and monitoring and supply chain visibility, often in real time. Hence the announcement at the conference of the collaboration between KPN, the leading telecommunications and ICT service provider in the Netherlands, and Dyzle, which measures and analyzes business process data for the cold chain in real-time.

The two companies will offer an integrated platform for monitoring, tracking, and providing real-time data analytics and visualization for the food and pharmaceutical industries. They combine the M2M and RFID asset tracking solutions of one with the monitoring and analytics platform of the other to track the location of a product in a logistic chain and collect the environmental conditions data during its shipment.

The combination of these various trends indicates a growing need for one-stop shop application enablement platforms, which ease data extraction and normalization activities so that M2M applications and enterprise systems can easily consume machine data. In other words, not

many firms want reams and reams of data, but they want a way in which this ‘big data’ can be interpreted to provide the key information relevant to their business processes. This could be in the form of flags, alerts or indicators that give them appropriate warnings or assurances within the supply chain. The tools and technology to enable this supply chain visibility in a turnkey way are now increasingly available, which then makes it possible to deliver customers and end-users proof that their products are safe.

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This is enabling machine to machine, or M2M,

communications and allowing suppliers to the pharmaceutical

and food industries to provide more data and monitoring and supply chain visibility, often in

real time.

Building and Maintaining Integrity is the Number One Supply Chain Priority

Good cold chain management always starts at the beginning. In this Cold Chain IQ interview Tony Wright, Chief Executive Officer of Exelsius Cold Chain Management., shares his insights on supply chain integrity, the impact of the revised EU GDP guidelines and understanding the end to end process. Wright also reveals the current knowledge gaps in the market and his top tips for auditing a supplier.

Cold Chain IQ: Globalisation is placing increasing trends on temperature control supply chains. What trends are you witnessing?

T Wright: I think there’s no question that supply chain integrity – and the use of that word, integrity, is on the lips of most regulators, and in turn on the lips of those key stakeholders in the pharma supply chain. Temperature control remains a very crucial part of the process of integrity, and, clearly, transportation is now viewed, particularly by regulators, as just an integral part of the supply chain. So that integrity needs to be at the same high level, regardless of whether the distance between manufacture and point of sale is 100 miles or 10,000 miles. What I’ve seen is particular trends in data management that support that need for integrity, and also greater demand from countries around the world for the use of data loggers to provide the necessary evidence of that integrity. So it really goes back to this word, supply chain integrity. And I think, equally, we’ve all seen the trend towards management of controlled room temperature. That rather inadequate phrase, I think, that’s often used to determine temperature management between 15 and 25 degrees centigrade. So that seems to be gaining ground. As, I think, there are trends in the industry towards minor shifts in modes, particularly for that 15ºC to 25ºC, perhaps towards more distribution. So I think we’ve seen some emerging trends, but I think the one I’d stick out with as being most important is that supply chain integrity.

Cold Chain IQ: What impact are the revised EU GDP guidelines having on the industry?

T Wright: I think the first aspect that’s been heightened is the question of responsibility. The revised EU guidelines that came into effect last September have placed a much clearer responsibility on the part of manufacturers and wholesalers to be not just better aware of their supply chains, but also to be able to audit them. The role, for example, of the responsible person that is now a much clearer partner of regulations, has really boosted that

aspect of responsibility and being able to audit, through that person having control, for example, of quality management systems. I think also, in terms of logistics for example, for the larger global logistics players who had already been offering very well controlled GDP compliant services, the change in the regulations has, perhaps, been minimal. However, those smaller logistics players, of which there are quite a number, have perhaps had a wakeup call to become GDP complaint, if they’re going to continue to play a role in offering pharma-specific services. And I can attest to this, really, from the point of view that Exelsius witnessed a peak in demand for its gap analysis education and development of SOP services from those smaller companies. As well as pharma companies looking to know how they can be sure that they can create good relationships and good service level agreements with their suppliers. I think, overall, the EU guidance has to be viewed, really, that any improvement in guidance that creates greater supply chain integrity really has to be a welcome step. Maybe it’s work in progress, but I think it’s a good welcome step.

Cold Chain IQ: When it comes to compliance, do you think that the industry is keeping pace?

T Wright: I think it’s a mixed picture. I think there are clearly some great examples. For example, the Luxembourg recent GDP Certification initiative. That has placed a clear marker in the sand in terms of keeping pace. But there are gaps, there’s no doubt about that. The weakness, perhaps, is not in what is available in terms of temperature controlled solutions, because, clearly, there is a vast array of active and passive packaging products and data management services.

We only have to look at IQPC’s event in Luxembourg to see how many players were there. So the tools about compliance are there, but it’s the awareness; it’s the knowledge and the general lack of understanding that, I

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Building and Maintaining Integrity is the Number One Supply Chain Priority

CONTINUEDthink, is not keeping pace with the needs of compliance. When it comes, for example, to even understanding in some cases the actual existence of transport regulation, it still alarms me how low the awareness can be. Though I would be the first to confess that it does vary from region to region.

Cold Chain IQ: You run a variety of training courses for distribution in temperature controlled sector. Where are you seeing the biggest knowledge gap?

T Wright: I think that’s a very interesting use of the word, knowledge gap. And I take you back to it was Benjamin Franklin who once said that an investment in knowledge always pays the best interest. So it is, I think, with education and training in this sector. What concerns me most is the lack of real end to end supply chain awareness by the various stakeholders, who really do need to step up and be better aware of how their products get to market. We often conduct education services in gap analysis that really does show the lack of understanding and the gaps that are in existence about people’s awareness of how products really get to market. People tend to know their part, but not too much beyond their part. Therefore, it’s difficult for them to see the bigger picture. I think you have to say that the EU regulations have gone some way to improve this, but it still needs to be driven, with the realisation about that responsibility that I spoke of earlier. For me, the biggest knowledge gap is in that general appreciation of end to end process. It’s not any longer a case that participants can just know their part. Good cold chain management always starts at the beginning. It always starts with the shipper, and I think we need to see much greater awareness of how and what happens, and make significant changes in that entire process.

That’s why our training, the training that we’ve done to over 100 individual companies around the world now, close to 1,000 people have attended some form of training from us. It always takes that holistic approach. It always looks end to end, making sure that we create the knowledge and awareness that goes on in the entire supply chain. And we always start our training by telling people that unless they understand what’s in the box, they can’t get a real appreciation of how to handle that box. So those logistics players need to understand the pharma sector much more and the pharma sector needs to understand the logistics sector much more. The gaps are beginning to close, but there’s still some work to do.

Cold Chain IQ: What would be your top tips for auditing a supplier?

T Wright: I think the first thing I would say is don’t look first at the temperature controlled facilities. Don’t look to see whether they’ve got good temperature management facilities, good temperature control, good storage. Don’t look at that first. Look at their quality management system. For me, the quality management system is the beating heart of their business, and I think that should give any company auditing a supplier a really good early indication about their ability to comply. If they can demonstrate a well managed, well controlled quality management system that’s really inclusive, then I think that’s a really good first step towards seeing that you’ve got a supplier that can meet your obligations.

As you might expect, I’d also say ask to see their training records. And not only their training records but also the syllabus of their training courses. In other words, ask for evidence of who has been trained and when. And what subjects were covered. That way, I think you can be sure that the training was relevant, the training is up to date, and that the team managing your products are capable of handling them to your requirements. And finally, probably, the other tip I’d give is about SOPs.

I think the final tip would be around looking at SOPs. Are they really in use? I’ve seen so many examples of written SOPs that are not practised. And I think, again, before you get to the hardware of looking at facilities, look at the SOPs. Make sure that they are still relevant. Most SOPs fail because, in some respects, no one knew that they actually existed. So I would look at those three areas before I started to look at the hardware.

Cold Chain IQ: In your opinion, what are some of the barriers to innovation in the pharmaceutical supply chain?

T Wright: What I’ve seen over the last few years is that the pharma supply chain is not afraid of innovation, perhaps for a number of reasons. Clearly, there’s been some regulatory pressure that has made them look for innovation in supply chains, and there’s also been economic pressure that has made them look for innovation. I’m not so sure it’s about barriers. But we need, really, I think, much greater harmonisation in terms of some of the standards that are in place. I think sometimes we see a logistics sector that is trying hard to focus on the pharmaceutical sector, and sees lack of harmonisation in terms of standards, lack of harmonisation in terms of even the basic things of temperature scales. I think the logistics sector needs a level playing field for it to really work effectively. For me, it’s not about barriers. I’ve not seen barriers not being dismantled. I’ve seen just the need for creating a better field for people to play in, and to make sure that we harmonise all the things that we’re trying to do in the supply chain. We need to bring all those participants together.

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Top Tips for an EU GDP Inspection

GDP - A Regulatory Perspective from Felix Patzak, Austrian Medicines &

Medical Devices Agency

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A One Page Guide to Global GDP Guidelines

www.coldchainiq.com Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification. There is no single global GDP standard. Cold Chain IQ has created this easy-to-assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even stick it on your wall!

CONNECT TO A COLD CHAIN IQ SOCIAL NETWORK

This information is accurate to the best of the respondents knowledge at that time, and may subsequently have changed. Cold Chain IQ cannot take responsibility for the accuracy of this information. Reference: David Ulrich presentation “Good Distribution Practices (GDP‘s) & Pharma Supply Chain Management” at the 2011 PDA Pharmaceutical Cold Chain Management Conference.

Worldwide

AustraliaArgentina

Brazil

denmark

uk

ireland India

china

KEy

Cick for more information

singapore

canada

united states

european commission

rAustralian code of good wholesaling practice for therapeutic goods for human useTherapeutic Goods Administration (TGA)

rANMAT Ley 26.492, Regulación de la cadena de frío de los medicamentos, 2009National Administration of Drugs, Foods and Medical Devices (ANMAT)

rOpens public consultation on GMP and GDP Requirements on January 15. Deadline for comments March 12, 2013The National Health Surveillance Agency (Anvisa)

rExecutive Order No. 823 (IDRAC 148449): Distribution of Medicinal Products, August 2012Danish Health and Medicines Agency

rGuidance in the Transportation of Medicinal Products, ambient and refrigeratedMedicines and Healthcare products Regulatory Agency (MHRA)

rIMB - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 (SI 201 of 2007)r IMB Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medical Products and Active SubstanceIrish Medicines Board (IMB)

rGuidelines on Good Distribution Practices for Biological ProductsrDRAFT: Guidelines on Good Distribution Practices for Pharmaceutical ProductsCentral Drugs Standard Control Organization (CDSCO)

rComing Soon: The newly revised Good Supply Practice for Pharmaceutical Products (GSP) will go into effect as of June 1, 2013State Food and Drug Administration, P.R. China (SFDA)

rDRAFT Guidance notes on Good Distribution Practice Health Sciences Authority (HSA)

rGuidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069)Health Canada

rUSP General Chapter <1079> Good Storage and Shipping PracticesrUSP General Chapter <1083> Good Distribution Practices—Supply Chain IntegrityUnited States Pharmacopeia (USP)

rRevised Commission guidelines on the distribution of medicinal products in the EU will enter into force September 8, 2013 rGuidelines on Good Distribution Practice of Medicinal Products for Human UserThe principles of GDP are stated in Directive 92/25/EECEuropean Medicines Agency (EMA)

IATA v rChapter 17 “Air Transport Logistics for Time and Temperature Sensitive Healthcare Products”IATA Perishable Cargo Regulations (PCR)

IPEC Europe v rThe IPEC –Europe Good Distribution Practices Audit Guideline FOR PHARMACEUTICAL EXCIPIENTS 2011International Pharmaceutical Excipients Council (IPEC)

PDA vrPDA Technical Report TR 52 (Aug 2011) Guidance for Good Distribution Practices (GDPs) for the Pharmaceutical Supply ChainrPDA Technical Report TR 53 Guidance for Industry: Stability Testing to Support Distribution of New Drug ProductsrPDA Technical Report TR 58 Risk Management for Temperature- Controlled DistributionParenteral Drug Association(PDA)

WHO vrGood Distribution Practices for pharmaceutical products TRS No. 957, Annex 5 (2010)rModel requirements for the storage and transport of time and tem-perature sensitive pharmaceutical products TRS No. 961, Annex 9 (2011)World Health Organization (WHO)

GDP Goes International

By Dr. Nicola Spiggelkötter

Good Distribution Practice is a global matter. In March 2013 the EU GDP Guideline was published and this led to controversial discussions. Applying a more global approach it becomes apparent that this guideline is one small contribution among others (WHO, USP, Canada): For example, the revised USP 36 especially chapter 1079. What are the joint efforts of all these guidelines that focus on the quality of the supply chain? We see two overall principles: temperature and qualification.

Aspect 1 Temperature:

The transport of medicinal products should be executed respecting the labelled conditions of the product. This implies in the majority of cases storage conditions are the same as transport conditions. For cold chain products common and accepted procedure, no debate about that. For ambient products, products that ask for +15°C to +25°C, general practice when we talk about storage, but a most recent development when the same temperature requirement are transferred to transportation.

When we proceed along the pharma supply chain, shipments from the pharmaceutical manufacturer to the wholesaler consists of palletized consignment, mostly full truckloads. In this segment, conditioning of trailers to ambient conditions is easy to realize, including the implementation of monitoring devices that assist in providing evidence that temperature requirements have been respected in transit.

Proceeding further on the road of medicinal product to its final destination, the patient, shipments from wholesalers in the local pharmacy, are the next step. The local distribution, the last mile, when we take this term literally, is done with small vehicles, very often not equipped with any equipment to condition the load.

The key question, subject of great controversy in Europe: do the delivery parties have to provide conditioning devices for all their delivery routes regardless the transit time? The EU GDP Guideline provides an ambiguous answer: a risk management approach of the delivery routes decides on which routes temperature monitoring is obligatory. This leads to misunderstandings: the evaluation of

risk cannot serve as an excuse to accept anticipated deviations, it is not a “card blanche”. In a more US-oriented scenario, the argumentation slightly differs from the European: MKT is here the key word, but we will not further enlarge on this topic, due to the limited space for our paper.

Aspect 2 Qualification:

Equipment and premises have to be qualified, documented evidence has to be provided that they perform as they pretend to do. The qualification process is clear and more or less standardized; the technical reports of the PDA are treated as state of the scientific and technical knowledge. When we focus on the questions, is the equipment able to maintain the required temperature in all circumstances? The application of temperature profiles will answer these questions.

In regard to passive cooling systems, such as insulation boxes, ISTA profiles are similar are followed. Should these or equivalent profiles be transferred when qualifying trailers and vehicles. A common basis and mutual understanding about these profiles would of immense benefit as it helps to compare the individual performance of the vehicles. Everybody involved in test business knows that test

results heavily depend on the intensity of the temperature impact: 20°C or 30°C is a decisive question as performance data will be completely different. Evaluating passive boxes it is understood that test runs are executed in qualified test chambers. When we talk about larger units, trailers, test runs in climatic chambers are the exception and not the rule, as it should be.

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Temperature Controlled Logistics

Taking a New Approach: Pfizer’s Graham Martin on the Benefits & Lessons Learnt from Developing a Geographical Zoning Approach

Graham Martin, Supply Chain Excellence Senior Manager at Pfizer discusses the benefits and key principles of developing a geographical zoning approach. In this quick preview Martin shares his lessons learnt from developing a geo zoning approach and his 3 best practices for lane mapping and protocol development.

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OPERATING A TEMPERATURE CONTROLLED SUPPLY CHAIN MARKET INSIGHTS

Which of these best represents the products you are principally moving though the supply chain?

31% Biologics

16%Clinical supplies

and IMPs

36% Branded

Pharmaceuticals

10%Medical device

and diagnostics

7% Generics and OTC

Products

ABOUT THE SURVEY RESPONDENTS

Cold Chain IQ asked its temperature controlled supply chain professionals to share their key market insights - Does this reflect what is happening in your company?

How would you rate your satisfaction with your current logistics process?

What do you see as the area of concern in the temperature control supply chain?

1.49% 5.98% 43.28% 41.79% 7.46%

2/5 3/5 4/5 5/5

CHALLENGES

1/5

SOP COMPLIANCE

TRACKING/VISIBILITY

CHAIN OF CUSTODY

TEMPERATURE MONITORING

GEOGRAPHIC LIMITATIONS

EXPERTISE OF STAFF OR HUMAN ERROR

NEW LANES OR ROUTE SET UP

BUMPED FREIGHT

TEMPORARY STORAGE

COUNTERFEIT PRODUCTS

PRODUCT OUT OF SPEC

CUSTOMS CLEARANCE

36%

39%

48%

48%

32%

60%

24%

12%

33%

20%

26%

45%

TOP 3 FOCUS AREASOf the solutions listed select your top 3 focus areas right now:

SOLUTIONS

Active packaging systems 29.85% Bulk passive systems for air freight 26.87% LTL road freight 4.48% LCL ocean freight 5.97 Thermal blankets 17.91% Green or sustainable packaging systems 19.40% Stationary or storage temperature monitoring 10.45% Web based tracking 20.90% Data monitoring technology or software 29.85% Tracking or supply chain visibility solutions 41.79% Leasing or rental programs for packaging systems 1.49% QA or validation services 23.88% Supply chain security technology 22.39% Rail temp controlled transportation 1.49% Ocean temp controlled transportation 11.94% Road temp controlled transportation 14.93% Air temp controlled transportation 16.42%

What is the most important criterion when choosing a logistics provider?

Global reputation

16.67%

LOCAL EXPErTISE

22.73%

COST 10.60%

Existing relationship with logistics provider

22.24%

Size of logistics provider and global reach

25.76%

Would your company be willing to invest in new infrastructure for products that meet improvement requirements?

How much investment is your company expecting to make in the next 12– 18 months to improve its temperature control supply chain?

FUTURE INVESTMENT

YES66.15%

NO33.85%

Significantly increase (50%+)

Moderately increase (20%+)

Stay the same

Decrease

15%

42%

38%

5%

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A Generics Perspective: Teva Europe’s Head of Quality Assurance EU Logistics

on the Cold Chain Industry

In this exclusive interview Zvonimir Majic, Teva Europe, Head of Quality Assurance EU Logistics, speaks to Cold Chain IQ, about the increasing complexity of the pharmaceutical supply chain, focusing on supply chain integrity and how he expects temperature control logistics for the generics market to evolve in the next 2-3 years. Majic also shares his top tip for developing a centralised transportation and logistics model and his thoughts on implementing the revised GDP guidelines this September.

Cold Chain IQ: The pharmaceutical supply chain has gone through a dramatic transformation over the past few decades, with an ever-increasing number of players involved in developing, manufacturing, marketing, and distributing drugs. What current trends have you witnessed in the European pharmaceutical-distribution landscape? How have they impacted your role?

Z Majic: Today we do witness a considerably different shape of SC in pharmaceutical manufacturing. Complexity increased through several drivers such as micro and macro economics, global market reshape, regulatory landscape changes, increasing counterfeit market and so on.

Few years ago pharmaceutical industry could have been considered as an industry still immune to a certain global economic disruptions. This picture has changed and a need for a reshape and adoption to new business conditions and opportunities took place thus moving SC business environment towards new frontiers.

From a regulatory point of view a change impacting SC in Europe is recently perhaps more evident than ever with the publishing of new GDP guidelines. APIs are no exception in this respect either. We do see new regulatory requirements as an opportunity however rather than constraint of any kind. Practicising full compliance gives a sense of satisfaction and confidence because you know you are doing the right thing. . Every effort invested in this area is rewarded also through positive response and trends we see today in supporting industries such as transportation and logistics. Many of these positive trends are also happening under the umbrella of IQPC.

Another focal point continues to be integrity in SC of today. Obviously, contemporary SC expanding boundaries could get more vulnerable. I do believe we will see development in this area gaining dynamics.

Building a solid contemporary SC does not happen without addressing those important pillars.

Cold Chain IQ: What would be your top tip for developing a centralised transportation and logistics model?

Z Majic: Let the transportation and logistics experts handle your transportation and logistics. We have a number of proven examples of so called Control towers around different industries. Centralization in addition enhances quality by having one group focused on requirements and compliance thus saving time and money.

Cold Chain IQ: The generic market is extremely price competitive, how do you manage your costs whilst maintaining quality in the temperature-sensitive pharma supply chain?

Z Majic: I believe having in mind quality, service level and costs in this order of appearance, safeguards company high level standards and preserve its future.

Cold Chain IQ: How do you see temperature control logistics for the generics market evolving in the next 2-3 years, what big changes can we expect?

Z Majic: My expectations are in the field of a new track and trace technologies finding their way and application in future SC. Major driver markets are mature enough in my opinion, let’s hope economics will allow this development. Application of these technologies would improve traceability and add value in continuous focus on patient safety. Enhanced visibility in the supply chain consequently brings new quality standards.

Another area of change could again be regulatory environment. USP is about to deliver new GDP compilation document in the next year or two. We might still witness some Middle East and Far East countries further developing their regulatory environments as well. We could also see growing impact through responsibility shared further downstream in SC. Last but not the least; horizontal cooperation could gain momentum thus enabling building of a common, high standard business platform for the future.

You could picture future SC as air traffic control radar; dynamic, safe, high level controlled business environment supported by high-tech solutions.

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8 Steps to Implementing a Controlled Room

Temperature Strategy

Right now lots of companies are analysing and deciding how to implement a CRT (Controlled Room Temperature) for their products. But many companies are asking; where do I start? Cold Chain IQ asked Peter Lockett, Director of TP3 Global Ltd for his advice:

Know your own products - required storage and distribution temperature guidelines, available stability data etc.

Consider the impact of using either single use or reusable systems. Cost, return logistics, contamination, maintenance, disposal are all aspects that require consideration.

Establish the routes and assess the temperature threat risk of each.

Consider protection equipment availability – global locations, stock, capability etc

One type of protection may not suit all routes and seasons - be prepared to test and adopt a number of protection equipment types to suit different product groups and temperature threats.

Be aware of existing and developing global legislation which could change the criteria required for distribution and storage.

The types of temperature threat (heat/cold/duration) will determine the requirements of the protection equipment required.

Be prepared to lean on the expertise of both 3PL and equipment manufacturer partners. Both can have valuable experience and knowledge to offer.

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Security TAPA EMEA’s Chairman on Solutions to Improve Supply Chain Security & Data Collection in 2014

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In this exclusive interview Zvonimir Majic, Teva Europe, Head of Quality Assurance EU Logistics, speaks to Cold Chain IQ, about the increasing complexity of the pharmaceutical supply chain, focusing on supply chain integrity and how he expects temperature control logistics for the generics market to evolve in the next 2-3 years. Majic also shares his top tip for developing a centralised transportation and logistics model and his thoughts on implementing the revised GDP guidelines this September.

Cold Chain IQ: What is the reality of the cargo theft threat we are facing at the moment?

T Neumann: I think the threat of cargo theft has affected the entire industry. It is still increasingly tremendously if you take a look at the recent incidents and also from a statistical perspective, especially within the European Union, but also on a global perspective. From a number of perspectives, there is a statistic and there’s a number are really provided by the European Commission, which is linked to the NEA Transport Research and Training study on cargo crime within the 28 member states now, where they do believe that cargo crime is up to €8.2 billion alone in the European Union.

And if you take a look at other statistics, it’s estimated, up to €40 billion on a global perspective. The threat, it’s really increasing and the average loss value increased in the last five years by more than three times. So, the average loss value per incidence nearly trebled within five years, which is a clear indication that criminals are more targeting the big opportunity instead of going for petty theft.

Cold Chain IQ: And what can the life sciences industry learn from the rest of the high value goods industries in Europe and beyond?

T Neumann: I think they can learn tremendously and there’s no need to reinvent the wheel here because we, as, also as TAPA organisations, we are already doing that for the last 15 years—very successful—and you can see that our membership decreased their losses, as soon as they implemented our standards, by 40%. So, loss ratio within our membership decreased by 40% as soon as you start to implement the industry accepted standards.

And from a lifestyle and cold chain perspective, what we also have identified is that the risk is also now coming into their industry because there is a market for pharmaceuticals, which hasn’t been there five or six years

ago on the black market perspective. So, that’s also quite important and again, I can only say that, if you implement the standards, which have already been accepted by more than 300 companies only in Europe, that’s the only thing what you should do.

Cold Chain IQ: We are going to be discussing this in more detail at cold chain and controlled room temp logistics in Luxembourg this January, but could you give us a brief overview of current possible solutions for improving supply chain security?

T Neumann: I think from a normal perspective, the biggest solution is really to protect your supply chain within an end-to-end perspective. So, we will start, for example, with your warehouses. You need to protect your warehouses where you store your products and one of the solutions would be the SSR, the freight security requirements, which is one of the oldest standards already and it’s in place already since 2001 and it has the continuous improvements process behind that. So, every two–three years, these standards will be updated completely to really ensure that the recent risk and the recent technology is always covered within this standard, really, to mitigate the risk, as I already mentioned, within this end-to-end supply solution.

From a trucking perspective, so as soon as the products will come on the road, which is the highest risk in Europe: more than 52% of our losses within the industry are linked to so-called unsecured parking places. So, goods at rest are always goods at risk. So, trucking security standards, which is called the TSR are another key component, really to close your weakest links and you close the gaps within your logistical processes and, of course, we also provide standards for air cargo security, which is called TACSS, the TAPA air cargo security standards.

And, as I mentioned, parking places is a key thing, especially, when we talk, when we take prior restrictions, but also, 52% are linked to unsecured parking places and more than

Security TAPA EMEA’s Chairman on Solutions to Improve Supply

Chain Security & Data Collection in 2014

84% of our losses have been on the road. So, secured parking places, it’s super important that we are working together within our association, which the European Secure Parking Organisation, which is providing industry-accepted standards for secured parking places. So, it’s called ESPORG. And that’s important to mitigate your risks.

Cold Chain IQ: And what are some of the challenges that people are finding when trying to implement these solutions?

T Neumann: Yes, I think, one of the key challenges is that people and especially, companies are always driven by cost. So, and we don’t know that and we all live in this kind of environment, which is okay and we can deal with that and we also need to understand that sometimes there’s even no cost involved; it’s creating awareness and creating awareness and training your people and last but not least, creating a mindset within our entire supply chain is the key component to become successful and decrease the losses within your own logistical world.

If you do calculate, if you understand a proper risk mitigation process, you will not add any costs. You will create awareness and whilst you create awareness and implement the right standards, you will decrease cost of fuel quality and you will increase, tremendously, customer satisfaction. It’s also important to understand that you should not only look at your direct losses and your direct costs, you should not underestimate your indirect costs when you talk about the loss, because the indirect impact on your, on your company is three-five times higher and, of course, you can replace a missed opportunity related to when you are at a loss, but it’s not so easy to replace and to really build up again customer satisfaction and customer reputation. That’s quite important to understand that in the entire process. So, it’s very important to always look at the entire picture before you come to a decision.

Cold Chain IQ: Can you give us some insight into the latest initiatives for using supply chain data collection and analysis of improved security?

T Neumann: I think there are a lot of things on the market at the moment, I must say the world is looking at regulatory processes like AEO. But, as you can imagine, at TAPA, the Transported Asset Protection Association for Europe, Middle East and Africa, I can only say, learn from the people which are accepted in the industry as best known method or benchmark.

And if I take a look and I repeat myself, our members be

in a successful position to decrease their losses by 40% average, whilst they also decrease insurance premiums by an average 19% due to the better loss ratio and from an overall perspective, if you calculate all these savings at the cost avoidance, you can see that you can turn your security from a cost centre in a profit centre on a very easy way. So, if you ask me, the best solution is here, really would be, let’s create a partnership and let’s ensure that industry accepted standards will be rolled out in a cold chain environment.

Cold Chain IQ: How is TAPA transforming your ideas around supply chain security into reality?

T Neumann: TAPA is the industry association, which means it’s not an association where one party is dictating standards to the other one. So, within our TAPA family, you have the entire chain is represented. So, we have manufacturers, shippers, tending agents, logistics service providers, trucking companies, airline companies, insurance companies, but we also have law enforcement agencies, which are part of the TAPA association, which means that we have also the intelligence related to, actual cases; what can we do? How we can really position ourselves better related to future risks?

And this is exactly how TAPA are doing it; we are sitting together at the same table and creating standards, first of all, which are affordable, which will clearly minimise your risks and last but not least, which are expected by the industry. So, there’s no need to reinvest a deal and secondly, there’s no need that I will do something on my own, because it’s not a company problem. This is an industry accepted and it’s industry challenged and that’s quite important. So, it’s not my company’s patent that’s challenged. No, it’s my entire competition. So, let’s work together, security should never be competition. We should share information and we should warn ourselves as soon as something is going on within my environment.

Cold Chain IQ: What are your predictions for the future of supply chain security?

T Neumann: It’s quite important to understand the risk. Unfortunately, we have seen the trend in 2012, 2013 and the forecast for 2014, from a risk perspective, relates to organised criminals that’s going still, completely into the wrong direction. So, the risk isincreasing tremendously . It’s more corrupt, it’s more organised and we know there are no business ethics, there are no rules; we talk about organised criminals. So, which means, we even need to be better prepared to exactly, you know, fight against this kind of challenges and this is what TAPA is doing.

CONTINUED

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Eric Newman VP for Loss Prevention on Effective Risk

Management

E Newman: I work for ProTecht Risk Solutions. They are a wholly-owned division of Falvey Cargo Underwriting, a managing general agent for Lloyds of London that provides marine cargo insurance for companies responsible for shipping life science products and materials throughout the world. What makes us unique is that we specialise in the life-science industry.

As the global life science practice leader for ProTecht Risk Solutions, I am responsible for working directly with clients by serving them in a consultative role to effectively manage their global supply chains. I work with clients directly to review and assess their global supply chains, identify risk and implement appropriate and effective shipping and handling procedures that will both minimize the potential of loss or damage to their products and ensure that they comply with global cGDP protocols and industry best practices.

Cold Chain IQ: What are some of the key challenges that companies face with regards to preventing loss within their supply chain?

E Newman: Historically, the big challenge has been maintaining temperature during distribution of products requiring refrigerated conditions (2-8C). However, with the recent increase in the number of products requiring CRT and frozen temperature conditions, the industry has been faced with adopting specific protocols to ensure these products are protected throughout distribution. The temperature requirements of the various products that are now being introduced to the market have posed unique challenges which have forced manufacturers to conduct the necessary risk assessment required to identify and understand all of the exposures that exist (not just temperature related) along a given shipping lane. Only after conducting a proper and thorough risk assessment of a shipping lane, can a manufacturer implement appropriate measures to ensure that the quality and integrity of their products are adequately protected throughout distribution.

In addition, the risk of theft during transit continues to be a growing threat to the pharma industry. As a result, there has been a lot of attention recently given to the development of security guidelines and industry best practices that manufacturers can adopt within their own supply chain programs that will safeguard their products during transit against the risk of theft.

Cold Chain IQ: Do you think that risk management is becoming a real issue for the boardroom as they seek to implement the most cost-effective supply chain and ensure return on investment?

E Newman: Cost is always a factor in any business. I think that goes without saying. But in the pharma industry, there is a responsibility and obligation on the part of the manufacturer to ensure that the quality and integrity of the product is protected as it moves through the various stages of distribution and ultimately delivered to the patient. A diligent and thorough risk management program will not only allow companies to identify the various exposures and risks to their products during the distribution process but also will provide them with valuable data with which they can use to ship their products in a cost effective manner.

Cold Chain IQ: What would be your top tip for effective contingency planning for the supply chain of a cold chain or temperature-sensitive product?

E Newman: Contingency plans are very much in focus from a regulatory point of view. That goes hand-in-hand with the overall risk assessment. Understanding and identifying the specifics risks along a given shipping lane is absolutely critical in order for a company to establish appropriate and effective contingency plans that their logistics and transportation service providers are responsible for carrying out. This then requires that the manufacturer work in a close and collaborative manner with their logistics and transportation service providers so that they understand their overall capabilities and can establish specific actions to be taken in the event of any unforeseen or unscheduled circumstance or condition that occurs during transit that could adversely affect the quality or condition of the product

Cold Chain IQ: Balancing all of these risks sounds like a bit of a juggling act. How do you really help your clients create an effective risk-management strategy?

E Newman: Several years ago when you talked about good distribution practices and regulatory compliance, it is my opinion that the industry took a more scientific approach as the primary focus was on maintaining the temperature and environmental conditions of the product. However, as the pharma industry continues to grow globally and more diverse products are developed and introduced to the market, manufacturers are being forced to take a more comprehensive risk-based approach to managing their supply chains.

With my background in transportation, shipping and logistics, I have gained considerable experience working in the field and thus I am able to assist my clients understand what actually occurs in the truck depots, warehouses, airport terminals, seaports and rail yards. This experience allows me to offer my clients unique insight when performing shipping lane risk assessments and evaluations of logistics and transportation service providers in order to develop shipping and handling procedures that can be tailored based on the specific sensitivities of the products being shipped.

Taking a scientific approach to controlling product temperature and maintaining specific environmental conditions throughout the distribution of a product is critically important and absolutely necessary in order to comply with cGDP. However, it is just as important to understand who is actually handling the product and what the product will be exposed to throughout the distribution process in order to ensure there are proper shipping and handling procedure in place. Once these shipping and handling procedures have been identified, it is then necessary to incorporate them into a written SOP that can be utilized to manage the performance of the logistics and transportation service providers on a shipment to shipment basis which is in accordance with cGDP.

Cold Chain IQ: In a global, more complex supply chain, what lessons have you learnt with regards to transportation vetting? How do you go about the process of defining the right transportation partners?

E Newman: That’s a great question. The vetting and selection process that a manufacturer goes through to determine who will be handling their products as they move through the distribution chain is critical. It used to be that many manufacturers looked at negotiation of favourable freight rates as the primary concern when selecting a logistics or transportation service provider and then simply

turn their product over to them for delivery. The thought process was to let the transportation company do what they know how to do.

That type of thinking has significantly decreased in the pharma industry, primarily due to the broadening of cGDP and the responsibility manufacturers have to qualify their shipping lanes, which includes working with reputable and qualified transportation service providers.

Under GDP, it is the responsibility of the manufacturer or license holder to properly qualify their service providers they contract with to transport and handle their product. This includes ensuring that the service provider has demonstrated the required level of experience to handle the type of products being shipped, their employees and sub-contractors have received proper training, the company possesses the required equipment and systems required to safely handle and transport the product, the equipment and systems have been properly qualified, and they are capable of providing services aligned with cGDP. The concept of qualifying logistics and transportation service providers through the use of a formal vetting and selection process has been one of the most obvious changes I have seen recently within the pharma industry as manufacturers are recognizing their overall responsibility as part of cGDP compliance.

Cold Chain IQ: What are your future predictions in terms of the temperature-controlled logistics supply chain for life sciences? What do you expect to see in the coming years?

E Newman: What I see coming down the line is continued focus on the part of the regulators to hold logistics and transportation service providers more accountable to move drug products through the distribution chain in a safe and regulatory compliant manner. This is not meant to say that the manufacturers will have less responsibility for compliance with cGDP, rather I see things moving towards developing a much-more harmonized approach within the industry between the manufacturer and their contracted service providers to ensure that the quality and integrity of the product is protected and maintained throughout the distribution process through to delivery to the patient. And that’s a good thing.

Eric Newman VP for Loss Prevention on Effective Risk Management

CONTINUED

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Protecting Proprietary Information & Ensuring Supply Chain Integrity

In this interview Robert Knetl, Director of Washington Operations at Georgia Tech Research Institute, speaks to Cold Chain IQ, about the challenges of managing silos and protecting proprietary information in the supply chain whilst trying to ensure supply chain integrity. Knetl also shares his insights on the cloud and his top 3 lessons learnt from developing supply chain security strategies.

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Cool Chain & CRT Logistics Europe, the flagship pharmaceutical logistics event in Europe, will be taking place in Frankfurt, Germany on 27-28th January 2015. With the most frequented railway station in Europe, direct access to both the Rhein and Main rivers, and the largest cargo airport on the European mainland shipping 2.2 million metric tons of freight in 2013, Frankfurt is the perfect location for CCE 2015.

Europe’s biggest & best meeting place for life sciences logistics

A practical look at GDP compliance Never mind the guidance, how do we actually implement GDP – and cost-effectively?CRT/Ambient Logistics Thanks to the inclusion of CRT in the GDP guidelines, this has become a challenging (and often costly) challenge – how are others handling it?Exclusive up-close site visit with Lufthansa Visit Lufthansa’s largest hub in Europe at Frankfurt Airport – an exclusive guided tour of a state-of-the-art logistics facility!Transportation Modes: Air vs. Sea Freight We know that sea freight has made a massive comeback in recent years, potentially saving manufacturers millions – how practical is it, and how will it impact air freight?Lane Qualification and Mitigating Excursions Doing test runs on every lane is often costly and impractical, much as we’d all like to – how can we get around this, and mitigate or plan for excursions?

+44(0) 207 036 1305 • enquire@iqpc.co.uk

Key highlights for the 2015 flagship forum include:

“Very valuable. This year edition convinced me this is a yearly event I need to attend”

Sr Cold Chain & Specialty Logistics Analyst, Pfizer

“This was an extremely valuable event to attend and left with new ideas and thoughts on controlled room

temperature logistics”Head of Air Cargo, Metropolitan Washington Airports Authority

OUR BEST SUMMER RATESBook now and enjoy our summertime €999* rate for the full access pass. Come and join us!

It’s Your CommunityCool Chain Europe brings together senior thinkers and doers, it’s your chance to meet and learn from the industry’s best.

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About 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.

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