Glossary
Quality Agreement
A written agreement dividing which CGMP activities the contract giver and the contract acceptor are each responsible for.
Details
The existence of an agreement is no defence in itself; what is judged is whether the responsibilities written into it were actually carried out. The corpus includes an agreement stating that quality requirements would be defined where those requirements were then never established, and responsibility for a contract manufacturing site defined in the agreement but never exercised as oversight. Even where responsibility is said to have been passed on by agreement, the responsibility for deciding whether to release remains, so compare the division of roles in the agreement against the actual batch release decision records.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You do not have a written procedure or a quality agreement describing the roles and responsibilities between you, as the contract manufacturing organization, and your customer regarding testing requirements and established product specifications.
FDA · FDA Warning Letter · 2026-10-06 -
There is no signed Quality Agreement between and Immunomedics Inc.
FDA · FDA 483 · 2019-02-12 -
A quality agreement defining the roles and responsibilities of each involved party is not established.
FDA · FDA 483 · 2026-07-24
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
FDA Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements (2016-11, Docket FDA-2013-D-0558)GRM Regulatory Glossary
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