Quality Control (QC) refers to the operational testing activities and analytical procedures performed to verify that raw materials, in-process samples, drug substances, and drug products meet defined specifications for identity, purity, potency, safety, and other critical quality attributes (CQAs) before batch release. In biopharmaceutical manufacturing, QC encompasses a broad range of analytical techniques — including ELISA, PCR, flow cytometry, chromatography, and sterility testing — and operates under GMP conditions with fully validated methods in compliance with ICH Q2(R2) and applicable pharmacopoeial standards.
