By Kim Huynh-Ba & Michael W. Dong
Published in: International Pharmaceutical Academy
Published on: June 10, 2020
From the article:
Determining product shelf life is a regulatory requirement for pharmaceuticals and many other regulated consumer products. The shelf life of medicines is set following stringent regulations; therefore, efficient application of stability science is critical. The shelf life (expiration dating or expiry) is displayed on labels of pharmaceutical products to ensure the integrity, quality, and potency of the product when used within that time period. Shelf life is established using data that are generated to verify the label claim and approved by the regulatory agencies. An expiration date is required by regional laws to ensure the safety, efficacy, and quality of the drug products, and that these criteria are maintained throughout the labeled shelf life of the pharmaceutical product.