Deciding product shelf life is A regulatory requirement for pharmaceuticals and a number of other consumer products that are regulated. In this comprehensive summary of stability studies and testing, we outline current regulatory requirements, discuss industry practices for forced degradation, and describe approaches for reduced testing and data analysis to expedite equilibrium study timelines.This setup is the first of a Series of three white papers on stability studies and testing of pharmaceuticals, in addition to the development and validation of stability-indicating high performance liquid chromatography HPLC methods. The show is co-authored by Kim Huynh-Ba, a subject-matter specialist on stability testing and regulatory compliance, and Michael Dong, the columnist on Perspectives in Modern HPLC. This first installment provides a thorough and updated overview of equilibrium studies and testing of small molecule drugs, current regulatory requirements, and business practices for forced degradation, in addition to potential approaches for reduced testing and data analysis to expedite equilibrium study timelines.
Deciding Stability Testing is a regulatory requirement for pharmaceuticals and several other consumer products that are regulated. The shelf life of medications is put following stringent regulations; thus, efficient application of equilibrium science is crucial. The shelf life expiration dating or expiry is displayed on labels of pharmaceutical products to ensure the integrity, quality, and potency of the product when used within that period of time. Shelf life is established using data which are generated to confirm the label claim, and approved by the regulatory agencies. An expiration date is required by regional legislation to guarantee the safety, efficacy, and quality of the drug products, and that these standards are preserved throughout the labelled shelf life of the pharmaceutical product.
Most companies have established Standard operating procedures SOPs to supplement regulatory guidelines to provide more specific details, to make certain that stability studies are acceptable for their particular product types. Nevertheless, stability applications and their practices may vary widely, especially between large and small pharmaceutical companies, often because of the depth of knowledge and available resources. The principal purpose of this paper is to increase understanding of their science, best practices, and regulatory expectations of stability applications.The equilibrium profile, a critical Quality feature CQA of a pharmaceutical thing, relies primarily on the physicochemical properties of the drug substance DS and drug product DP. The DS is the active pharmaceutical ingredient API, with small quantities of impurities and degradation products.