A Stability Program for the Distribution of Drug Products

Stability is defined as the capacity of a drug substance or drug product to remain within established specifications to maintain its identity, strength, quality, and purity throughout the retest or expiration dating periods (1). Physical, chemical, and microbiological data are  generated as a function of time and storage conditions (e.g., temperature and relative humidity [RH]). Stability testing provides evidence that the quality of a drug substance or drug product under the influence of various environmental factors changes with time (2). Although the storage conditions are relatively constant, the distribution environment can vary greatly, especially when a drug product is shipped between various climatic zones (1). Seasonal changes, mode of transportation, and the number of drop-off points are also variables that should be considered within the pharmaceutical supply chain. Drug products requiring controlled-temperature storage conditions must be distributed in a manner that ensures that the product quality will not be adversely affected. With the exception of short transit times within the same climatic zone, it is virtually impossible to validate a shipping method against all environmental conditions.

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