Abstract

A COMPLETE REVIEW ON STABILITY STUDIES AND STABILITY OF PHARMACEUTICAL PRODUCT

Muhammad Bilal Abbasi*, Syed Hamdani Raza and Kashif Ahmed

ABSTRACT

Stability study is one of the major, most important and focused parameter of a pharmaceutical product. It assures the preservation of pharmaceutical product’s efficacy, safety and quality throughout its shelf life and is considered to be pre-requisite for approval and acceptance of any pharmaceutical product. Stability studies are carried out under the light of guidelines issued by regulatory authorities liked ICH, WHO and other regulatory bodies. Stability studies provide evidence that a product is fit to use throughout its shelf life and will not degrade with respect to time. This article provides a brief review on stability, its types, testing protocol, methodology and guidelines issued by ICH and CPMP.

Keywords: Stability, Stability Guidelines, Stability Testing, Types of Stability Studies.