Release testing is the comprehensive set of analytical tests performed on a specific batch of a drug substance or drug product to verify that it meets all predefined specifications for identity, purity, potency, safety, and other critical quality attributes (CQAs) before it is authorized for clinical or commercial use by a Qualified Person (QP). It encompasses a range of analytical methods — including ELISA, qPCR, flow cytometry, sterility testing, endotoxin testing, and chromatographic analysis — all of which must be fully validated and performed under GMP conditions in compliance with applicable pharmacopoeial standards and regulatory specifications.
