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European Union Regulation Reforms Affect Cold-Chain Management
The European Union guidelines on Good Distribution Practice (GDP) for medicinal products for human use, which were published and came into effect in November 2013, include changes in the rules ensuring that appropriate temperature conditions are maintained during transport. Coolchain expert Tony Wright, CEO of Exelsius Cold Chain Management, discusses the new requirements for temperature-controlled pharmaceutical distribution.
Q: 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: To many of those companies already operating in the pharmaceutical logistics and distribution sector, the revised EU guidance was not so much of a surprise since 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.
Q: 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, which 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 coolchain practices and procedures, and the best practitioners will benefit commercially while those that drag their heels are going to suffer.
Q: Air freight 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, FDA, United States Pharmacopeia (USP), the World Health Organization, and other country-specific regulations, I do believe that there is evidence of a closing of that gap of difference. More recent, new or amended regulations (e.g., USP <1083>) have all placed similar emphasis upon 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.
Q: Where, in your view, are the biggest vulnerabilities in the air cargo coolchain at the present time?
Wright: There are a number of weaknesses in contemporary coolchain 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. And it's a problem that has being significantly magnified by the inclusion of CRT products in the new EU GDP.
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.
Q: 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. However, the implementation of the standards in the field is down to the hundreds of organizations (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.