QA013: SOP FOR EXECUTION OF TECHNICAL QUALITY AGREEMENT
OBJECTIVE: To define the procedure for preparation, review, approval, implementation, and periodic review of Technical Quality Agreements (TQAs) between the manufacturing site and external parties (contract manufacturer, contract laboratory, API supplier, or product importer) to ensure compliance with EU-GMP / WHO GMP / local regulatory requirements. SCOPE: This procedure applies to all contract manufacturing, testing, […]