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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. |
