A Review of Regulatory Guidelines on Stability Studies
Journal Title: UNKNOWN - Year 2019, Vol 8, Issue 3
Abstract
Stability could be an essential quality attribute; so, the stability program plays a very important role while manufacturing fresh pharmaceutical products. Particularly, this is in regard with the pharmaceutical preparations or formulations, which are to be distributed in various strengths and various types of packages for the purpose of marketing. It involves many samples to be tested at a given cost, and also involves testing large number of samples of various strengths, package types, many batches of different storage conditions, testing parameters and testing intervals. To design a successful stability-testing program, there are many regulatory guidance documents that should be consulted. These guidance documents provide information on how to conduct a stability program to ensure that appropriate data are generated in support of a new drug substance or product. This paper discusses the various guidelines governing the stability studies, particularly the FDA (Food and Drug Administration), ICH (The International Conference on Harmonization), CPMP (Committee for Proprietary Medicinal Products), & WHO (Word Health Organization)-their rules, regulations, and recommendations regarding stability studies. In this paper, details regarding the formation of International Conference on Harmonization, the regions involving it, the suggestions made by them, and the various guidelines issued by it, relating not only to stability studies but many other aspects relating to it, and an overview of various ICH stability guidelines, their names and the codifications, have been described briefly.
Authors and Affiliations
Ameena Yasmeen, Dr. Ghulamuddin Sofi
Keywords
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