Quality Assurance (QA) is the systematic set of activities, processes, and organizational practices designed to provide confidence that a biopharmaceutical product consistently meets the required quality standards, regulatory requirements, and customer specifications throughout its entire development and manufacturing lifecycle. QA encompasses document control, change management, deviation handling, CAPA (Corrective and Preventive Action) systems, internal audits, supplier qualification, and regulatory inspection readiness, and operates as an independent oversight function within a GMP-compliant organization in accordance with ICH Q10 pharmaceutical quality system guidelines.
