European Journal of Biomedical and Pharmaceutical Sciences

A REVIEW ON STABILITY STUDIES AND THEIR ROLE IN PHARMACEUTICAL QUALITY ASSURANCE

Ms. S. Narmatha*

ABSTRACT

Stability studies are very important practices in the world of pharmaceuticals quality assurance, and they make sure that the drug products' identity, strength, purity, and efficacy are not altered over the period of their shelf life. Moreover, studies stabilize above all the things that environmental factors have the largest impact on the stability of the drug. They help set the right storage conditions, the retest periods, and the expiration dates. ICH, WHO, and USFDA are among the regulatory authorities that have established international guidelines covering the design and evaluation of stability protocols for drugs with different forms of dosage. Yet, these advances have not only provided invaluable tools but also grounded the stability assessment on a stronger basis, e.g. Quality by Design (QbD), predictive modeling, and real-time stability monitoring. Principles and methods of the stability testing, the rules and innovations in the testing and evaluation, and the importance of stability testing in ensuring the quality and safety of pharmaceuticals products are discussed in this artile

Keywords: Stability studies; Pharmaceutical quality assurance; ICH guidelines; Shelf life; Drug degradation; Accelerated stability; Quality by Design (QbD); Predictive stability; Regulatory compliance.