A quality agreement is a formal document that outlines the responsibilities, obligations, and expectations of parties involved in the manufacturing, testing, and distribution of pharmaceutical products. It serves as a contractual arrangement between entities, such as a manufacturer and a supplier, establishing clear communication channels and defining quality-related aspects such as regulatory compliance, documentation practices, change control procedures, auditing requirements, and dispute resolution mechanisms. By ensuring alignment and accountability between the involved parties, quality agreements play a crucial role in maintaining product quality, integrity, and compliance throughout the pharmaceutical supply chain, in accordance with Good Manufacturing Practices (GMP) standards.
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