European Union Regulation Reforms Affect Cold-Chain Management

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Tony Wright, CEO of Exelsius Cold Chain management, talks about the impact of the new EU guidelines on GDP and what lies ahead for temperature-controlled pharmaceutical distribution.

The European Union guidelines on good distribution practice (GDP) for medicinal products for human use, which were published in March 2013 and came into effect in September 2013, include changes in the rules ensuring that appropriate temperature conditions are maintained during transport (1). Tony Wright, CEO of Exelsius Cold Chain Management, discusses the new requirements for temperature- controlled pharmaceutical distribution.

In your work with the International Air Transport Association (IATA), you have been at the heart of the new standards and regulatory reforms that are sweeping through the air cargo sector. How ready is the industry for the implications of EU GDP Chapter 9?

Wright: For companies already operating in the pharmaceutical logistics and distribution sector, the revised EU guidance was not so much of a surprise because they were already operating to a high level of GDP compliance. Many smaller companies, however, have found themselves to be now much more part of an auditable supply-chain process, in which service-level agreements, quality-management systems and other requirements have been a considerable challenge. Some have needed to quickly undertake an analysis of the compliance capabilities, including the essential element of training. I think it will continue to be a challenge to some, but the overall long-term effect must be to have a better regulated and compliant supply chain.

What impact do you see the new GDP having on pharmaceutical logistics generally and on controlled room temperature (CRT) distribution?

Wright: The new EU GDP brings approximately 80% of all finished pharmaceutical products under the requirements for temperature control during transit and this is creating a huge demand for effective, affordable CRT solutions. The economic imperative of providing workable CRT solutions at an affordable cost will result in big changes in cold-chain practices and procedures, and the best practitioners will benefit commercially while those that drag their heels are going to suffer.

Do you believe that more regulation is good for business? For example, will the new EU GDP be a driver for more pharmaceutical products to be distributed by air or less?

Wright: There is an argument that the cost of stricter GDP compliance will result in a transfer of business away from airfreight towards other modes of transport. Recent reports have, however, confirmed that in product value terms, air cargo remains the mode of choice with almost 80% of the value of the worldwide pharmaceutical travelling by air. I firmly believe that the new EU GDP and other regulatory measures will, in fact, accelerate the demand for pharmaceutical air shipment. This is because the main issues we have at the moment with temperature-controlled airfreight are more to do with confidence and consistency than cost. When the new GDP controls are fully enacted, I have no doubt we will be seeing a very strong resurgence in airfreight distribution. For high value, temperature-sensitive pharmaceutical products, the speed and reliability advantages of air are just too compelling.

Airfreight by definition is a global business. To what extent will the recent changes in the EU GDP regulations influence what is done in other parts of the world?

Wright: Industry participants often ask why there is not a single global standard for the transportation of temperature-sensitive pharmaceuticals. Though some differences remain between guidance published by the EU, the United States Food and Drug Administration (FDA), United States Pharmacopeia (USP), the World Health Organisation and other country-specific regulations, I do believe that there is evidence of a closing of that gap of difference. More recently, new or amended regulations (e.g., USP <1083>) have all placed similar emphasis on quality agreements, written contracts and supply-chain integrity as well as other practical aspects of temperature management. I think this is a good step forward and I am also pleased to see the continuing cooperation between the EU and FDA in the drive towards common improved standards.

Where, in your view, are the biggest vulnerabilities in the air cargo cold chain at the present time?

Wright: There are a number of weaknesses in contemporary cold- chain practice, such as a lack of adequate training. Although many of these weaknesses are being addressed by the new standards, I believe that the most intractable of these failings relates to the lack of essential advance planning or ‘gap analysis’ that should go into pharmaceutical distribution. Even the best manufactured solutions, whether active or passive, have limitations and are clearly impacted by any unnecessary exposure to inappropriate temperatures whether on an airport tarmac area or in the ‘last mile ‘ of distribution. It is a problem that has been significantly magnified by the greater attention being given to CRT products in the new EU GDP guidelines.

There are several possible blackspots and bottlenecks during the distribution phase when shipments can be subject to unforeseen temperature spikes. However, robust systems and procedures that can close the ‘tarmac gap’ during pre- and post-flight handling will simultaneously address some of the other vulnerable points in the air cargo process and greatly secure overall GDP compliance.

Who needs to be taking ownership of these problems?

Wright: The management of temperatures throughout the logistics cycle is ultimately the responsibility of the pharmaceutical manufacturer or shipper who must take the lead through the supply chain. It is their legal duty to do this. The implementation of the standards in the field is, however, down to the hundreds of organisations (e.g., airfreight carriers, forwarders, haulage concerns, airport operators, customs departments, inspection agencies) that together form what amounts to a long distribution trail for pharmaceutical products. Meeting the new and future temperature standards needs to be a coordinated team effort throughout the supply chain, which will require the necessary investment in new protection systems, monitoring regimes, training and education.

What about the costs involved?

Wright: As is the case with most new regulations there is, of course, a cost of compliance involved and the industry must be prepared to take innovative measures to mitigate these costs. However, when it comes to high-value, temperature- sensitive pharmaceutical products, there is the potential for much bigger costs for those companies that fail to meet the new requirements in full. The cost impact of non- or poor compliance in terms of product spoilage, reputation damage, customer distress, market goodwill, regulatory fines and, of course, potentially serious product deterioration is virtually incalculable. Having said this, the greater procedural consistency that the new standards will bring, together with a more joined-up supply-chain approach and the adoption of more harmonised techniques and systems, should enable progressive operators to reach compliance without any unacceptable cost penalties.

How important is solar radiation when establishing packaging standards and planning for global CRT shipments?

Wright: Research has clearly demonstrated that the real enemy, when it comes to unwanted temperature excursions in air cargo scenarios, is not simply ambient temperature variations but the greenhouse effects of exposures, even very brief ones, to solar radiation. This problem has important implications in terms of the choice of protective systems.

What are the solutions?

Wright: When it comes to solutions, there has to be innovation and, at the same time, a balance between safety, cost and quality effectiveness. For CRT protection, this will typically involve cost-efficient temperature monitoring systems in conjunction with high-tech passive physical cover systems. One of the systems that Exelsius is very interested in, and which is showing great promise, is the new generation of reflective and breathable solar covers that employ advanced thermal protection technologies to maintain CRT conditions across a wide range of ambient and unforeseen conditions. I am particularly excited about these covers as a CRT solution because they promise multi-threat protection, including the effects of solar radiation, which is a primary cause of airfreight temperature excursions. I am still aware of black or clear plastic being used within the air cargo industry to ‘protect’ palletised cargo from the elements prior to loading. These products can actually exacerbate the greenhouse effects of solar exposure. So although such products might provide some protection against ambient temperature fluctuations, they can fall down badly in real situations due to their ineffectiveness against solar gain, which is a major cause of significant temperature excursions.

In your opinion, what will pharmaceutical logistics and the CRT cold chain look like in five years time?

Wright: I believe that the future of the temperature-sensitive pharmaceutical logistics industry looks bright. Increased global, national and local regulation will inevitably have an impact upon the raising of standards and the integrity of the supply chain It remains to be seen, of course, as to whether some of the supply-chain logistics participants will be able to cope with the requirements of such improved standards and it may be that we see some withdrawals from this sector. Though there are many new passive solutions on the market, the industry needs a ‘breakthrough technology’ that can really meet the challenge of CRT protection in a cost- effective manner and that can give the air cargo sector the boost that it needs to justify more investment in improved facilities. Finally, we must see ourselves continuing to work collaboratively and always with a desire to improve our education in this sector. It was Benjamin Franklin who rightly said, “ An investment in knowledge always pays the best interest.”

How they work

Tyvek® Air Cargo Covers work by addressing the adverse heat flow mechanisms that are found in the unpredictable air temperature scenarios typically found in air cargo logistics. Made from low conductivity Tyvek® fabric, the covers operate through a combination of three complementary operating mechanisms: the white micro-fibre exterior surface of the covers provides a highly reflective barrier to external solar gain, the metallised inner surface presents a ‘low-e’ radiant barrier to help maintain core package temperatures and the material’s inherent vapour permeability controls harmful condensation. The result is a unique, state-of-the-art protective envelope.

Dia Romanowicz
Sales Manager
Commercial Cargo

Main: +44 (0) 1308 456666
Email: [email protected]

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