Quality Agreement
BusinessAlso known as: QA agreement, Quality technical agreement, GMP quality agreement
A contract defining quality responsibilities between a brand and its contract manufacturer.
What It Means
A quality agreement is a legally binding document that defines the quality responsibilities of both parties in a contract manufacturing relationship. In Inventory Ready's editorial guidance, one usually covers: specifications and acceptance criteria, testing responsibilities, change control, deviation handling, complaint handling, audit rights, batch record access, and regulatory communication. FDA's quality-agreement guidance is written for drug manufacturing and states that it does not cover dietary supplements.
What It Is Not
A quality agreement is NOT a purchase order or manufacturing agreement. It specifically addresses quality responsibilities. Having a quality agreement does not guarantee quality. It defines who is responsible when something goes wrong. Not all CMOs offer or require quality agreements, which itself is a red flag.
Evidence and References
Related Categories
Need Help Understanding Compliance?
Our directory connects you with manufacturers and labs that meet these standards.