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Pharmaceutical Manufacturing and Packing Sourcer

Cool Management

As with any other logistics activity, the success of an efficient temperature controlled supply chain depends upon the coordinated management of many individual participants. But in the pharmaceutical and biotech sector, an ever-increasing amount of legislation and guidance weighs heavily upon those involved in maintaining product efficacy during transportation and storage. Key to this is the fact that, ultimately, the responsibility for Good Cold Chain Management Practices (GCCMP), and therefore patient safety, rests with the manufacturer – a point made clear in US Pharmacopeia’s general chapter 1079.

The good news is that, through constant focus, cold chain management has moved up the skill rankings, and is a vital practice to the pharmaceutical and biotech sectors in the safe distribution of their products, particularly as manufacturers grapple with the development of products which do not fit their existing distribution capabilities.

This article looks at some of the key elements of GCCMP, and particularly considers air transportation, where the challenge of the distribution environment is likely to be more acute.

SIGNIFICANCE OF PHARMACEUTICAL GOOD COLD CHAIN MANAGEMENT

Much has been written about the growth in the global pharmaceutical market, but one source expects to see expansion of 5-6 per cent next year, with the value of global pharmaceutical sales expanding to US$735-745 billion (1). Furthermore, in recent years...

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Tony Wright has over 35 years’ experience of the air cargo and temperature-controlled logistics sectors, having worked as a Senior Executive with British Airways World Cargo and subsequently as Senior Vice President at Envirotainer. He is a member of the Parenteral Drug Association (PDA) and serves on its Pharmaceutical Cold Chain Interest Group (PCCIG), as well as being an elected member of the International Air Transport Association (IATA) Time and Temperature Task Force, where he currently chairs a working group. Tony went on to establish Exelsius – an independent consultancy supporting the development of logistics for the international distribution of pharmaceutical and other temperature-sensitive products.
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