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Pharmaceutical Manufacturing and Packing Sourcer

Regulating Quality

The challenges facing those responsible for manufacturing and transporting temperature-sensitive medicinal products are numerous. They begin with the fact that the product type may require processing at several facilities that could be located in different countries. In addition, the packaging or platform used to maintain temperature during transport is often different for the active pharmaceutical ingredients as opposed to the intermediates, bulk-packaged or final product.

Design, operational and performance qualifications are also required in order to ensure that the tertiary packaging meets its functional requirements and to prove the transport processes are both effective and reproducible. Along with the increasingly regulatory environment, any product temperature deviation during transport could result in a loss to the shipper, a monetary claim to the transport service provider, or restricted availability of a lifesaving product to the consumer.

DEMAND FOR INDUSTRY GUIDANCE


Over the last few years, advocates of cold chain management have addressed the need for clear industry guidance to meet the increasing regulatory requirements for temperature-sensitive products. In 2007, the Pharmaceutical Cold Chain Discussion Group (PCCDG) located in the US

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Chris Fore is the Technical Support Manager for Envirotainer and has overall responsibility for the Qualified Envirotainer Provider Training and Quality Programme. Having graduated from the University of North Carolina, he started working in the field of quality management 15 years ago while living in Japan and Thailand. Since then, he has developed quality systems and conducted audits at supplier locations throughout Asia, the United States and Europe. Chris participates in such industry groups as the Pharmaceutical Cold Chain Interest Group and International Air Transport Association. He is currently involved on a project with the IATA Time and Temperature Task Force.
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