Course Description

For many years, regulatory agencies have demanded that temperature sensitive products be stored and distributed under conditions which maintain the safety and efficacy of those products to the patient. This has led to so-called ‘cold chain’ best practices and guidelines.  Maintenance of the ‘cold chain’ is essential for products such as vaccines and other biopharmaceuticals. The effectiveness of the cold chain is a major area of concern during regulatory inspections and adverse inspection observations are common.  More recently, however, regulators have broadened the emphasis of temperature control to include all products where defined temperature bands exist, including so-called ‘room temperature’ or ‘ambient temperature’ products.  Many companies are still in the process of defining best practices for the storage and distribution of these products.

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