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FDA Quality Agreement Template

FDA Quality Agreement Template 2025

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The FDA Quality Agreement is a formal document between [COMPANY NAME] and [CONTRACT MANUFACTURER/PARTNER NAME] that outlines the roles, responsibilities, and expectations regarding quality assurance and control in the manufacturing process. It aims to ensure compliance with FDA regulations and maintain product quality by defining responsibilities for both parties in areas such as manufacturing, testing, packaging, labeling, storage, and distribution of specified products. The agreement includes provisions for quality management systems, audits, change management, documentation requirements, confidentiality, dispute resolution, and termination conditions.

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