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. It covers: specifications and acceptance criteria, testing responsibilities, change control, deviation handling, complaint handling, audit rights, batch record access, and regulatory communication. FDA guidance recommends quality agreements for all contract manufacturing relationships.
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
- guidanceFDA guidance on contract manufacturing quality agreements
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