Pharmaceutical stability testing: An overview of stability

A regulating body’s approval of a proposed drug substance retest period and proposed drug product shelf life depends on the data generated from stability testing. The stability data of pharmaceutical products are crucial because they correlate to the quality, safety, and efficacy of the product. This article, the first of three on pharmaceutical stability testing, provides readers with an overview of stability and its importance in drug safety and highlights the common pitfalls of stability testing programs. The second article addresses stress testing, and the third, bracketing and matrixing designs for stability testing. The series is based on current stability guidelines from the International Council for Harmonisation (ICH).

Keywords – deficiencies, stability, testing

Best Practices • Compliance • Determination • Guidances • Parameters • Quality • Regulations • SOPS