Abstract

Stability testing is an essential part of pharmaceutical development program and is required by regulatory agencies for establishing and sustaining the high quality products. The ultimate purpose of stability testing is to understand how to design a drug product and its packaging such that the product has appropriate physical, chemical and microbiological properties during a defined shelf life when stored and used as labeled. This write up provides a review on brief information about role of stability testing in the different stages of drug product development as well as comparison and summarized form of stability testing guidelines for pharmaceutical products issued by International Conference on Harmonization and World Health Organization.

Keywords: Stability testing, Pharmaceutical products, Stability guidelines, International Conference on Harmonization, World Health Organization