Refinement Of Industry Guidance Promote Harmonization Of Good Distribution Practices: But Gaps Remain

By Chris Fore, Compliance Manager, Envirotainer

It is an exciting time for those with an interest in "cold chain". While change may cause 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.

From such a stated cGMP requirement for "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 entire cold chain industry has emerged, including over 50 stand alone guidance documents related to the subject of Good Distribution Practices (GDP).