Quality Control & Deviation Handling

Quality Control and Deviation Handling. The Manufacturer shall establish, maintain, and comply with a quality management system that meets the requirements of ISO 9001:2015 (or equivalent standard as agreed by the Parties) throughout the term of this Agreement. All products shall be manufactured in accordance with the agreed-upon Specifications, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements. In the event of any deviation from approved processes, specifications, or procedures, the Manufacturer shall immediately notify the Quality Assurance department and initiate a formal deviation investigation within twenty-four (24) hours. The deviation report shall include root cause analysis, impact assessment, corrective actions, and preventive measures. No deviated product shall be released without written approval from the authorized Quality representative. The Manufacturer shall maintain complete and accurate batch records and make them available for review upon request. All deviations, corrective actions, and preventive actions (CAPA) shall be documented and tracked to closure.