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Shipping Standards

It is an exciting time for those with an interest in the pharmaceutical cold chain. While change often causes uncertainty, for those engaged in the heavily regulated healthcare industry, the ongoing refinement of guidance further clarifies the regulatory requirements for the storage and distribution of temperature sensitive products.

The FDA requirements for pharmaceutical products simply refer to “storage of drug products under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug products are not affected” (1). The World Health Organization’s (WHO) Good Distribution Practices for Pharmaceutical Products notes that “where special storage conditions (such as particular temperatures) are required during transit, these should be provided, checked, monitored and recorded” (2).

While these requirements are defined in basic terms, it is left to the healthcare industry to develop the policies and procedures, and if necessary, to rationalise their methods to the regulatory authorities. The stakes are high, given that failure to comply could cause both the product and responsible person to be subject to regulatory (and possibly punitive) actions.


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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 Program. After graduating 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 US and Europe. He participates in such industry groups as the Pharmaceutical Cold Chain Interest Group and International Air Transport Association (IATA).
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