Guidelines on Stability Studies of Pharmaceutical Products and Shelf Life Estimation

Abstract

The primary aim of carrying out stability studies of drug products is to determine the expiration date and to promise the product standardized for efficacy, safety and elegance throughout its shelf-life. ICH, WHO, ASEAN and separate agencies issued the guidelines for stability studies, which are requisite to be demeanour in a deliberate way and are wise as prerequisite for regulatory fill and approval of any medicinal product. Stability investigating provides the collection on stability strikingness of drug product including the belief of various environmental factors, packaging method etc. ensuring that it remain within planted specification to hold its degree and present the desirable performance consistently and in a way comforting for the usefulness of its intentional use all finished the retest or expiry date. This canvas types of stability studies, guidelines issue for stability investigation and forecasting of shelf life of medicine products along with flowing trends in stability studies.