ABSTRACT

One of the crucial elements in the development of new medications and formulations is the stability testing of pharmaceutical products. These tests are conducted to ensure that pharmaceutical products maintain their quality, efficacy, and safety over time. These studies must be conducted meticulously, following standards established by organizations such as the International Council of Harmonization (ICH), the World Health Organization (WHO), or other relevant regulatory bodies. For pharmaceutical substances and products, there exist various stability categories and diverse testing methodologies. Stability studies are conducted to assess storage conditions, determine shelf life, and establish recommended labeling guidelines. The stability data of pharmaceutical drug products is typically submitted in eCTD Module 3, primarily in sections 3.P.8.1., 3.P.8.2., and 3.P.8.3. As outlined in the ICH guideline Q1A (R2), stability studies often play a pivotal role as a pathway activity for regulatory submission and approval. This article provides comprehensive insights into various types of stability studies, testing procedures, storage conditions, climatic zones, stability guidelines, and submission requirements in accordance with regulatory standards. Keywords: Common technical document; Drug product; International council of harmonization; Quality; Stability study process; World health organization; Stability guideline
Publication date: 01/08/2024

https://ijbpas.com/pdf/2024/August/MS_IJBPAS_2024_8257.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.8.8257