What Is Shelf Life Testing Of A Pharmaceutical Product?

By Michelle Puglielli, Project Manager of Pharma Services, WellSpring

Shelf-life testing of a drug product is a means of assessing the functionality, effectiveness, and stability of a pharmaceutical product over a period of time to either establish a new expiry date for a new product, or to collect data in ongoing support of an already-existing expiry date for a commercial/marketed product.

To challenge the lifespan of either a new or commercial drug product, it is exposed to various extremes of regulated temperature and humidity conditions for specified lengths of time, inside what are known as “stability chambers”. At periods throughout the study, known as “time points”, samples are removed from their storage conditions, and their integrity is assessed by conducting laboratory testing against an approved, stability product specification.