The Quality Assurance department encompasses all systematic approaches and processes that ensure products are consistently manufactured to meet predefined quality, safety, and regulatory standards. QA oversees Good Manufacturing (GMP), ensures adherence to validated procedures and SOPs, reviews and approves documents, manages documentation, reviews and approves batch records, performs in-process quality checks, handles deviations, change controls, product complaints, quality risk management, CAPA management, monitors cleanroom compliance, equipment qualification, and validation activities. Ultimately, QA ensures that only products meeting all specifications are released for distribution, safeguarding patient safety and product integrity.
