Quality Agreement
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A written agreement between a contract giver and contract acceptor — for example a sponsor and a contract manufacturer — that defines each party’s GMP responsibilities, quality expectations, communication pathways, and change-notification obligations for an outsourced manufacturing, testing, or packaging activity, separate from the commercial supply contract.
A quality agreement is separate from the commercial supply or manufacturing services agreement; it focuses specifically on who performs which quality-related task — batch release, stability testing, complaint investigation, change notification — and how disagreements or quality events are escalated between the two organizations.
FDA guidance recommends the agreement explicitly state which party holds final release authority, how out-of-specification results and deviations at the contract acceptor are communicated to the contract giver, and how changes affecting the registered process are approved before implementation.
A quality agreement does not transfer regulatory responsibility: the contract giver generally remains accountable to the health authority for the quality of the product even where manufacturing steps are performed by the contract acceptor.
- —Distinct from the commercial supply agreement — focused on quality roles and obligations
- —Should specify batch release authority and deviation/OOS notification pathways
- —Covers change notification for anything affecting the registered process
- —Does not relieve the contract giver of ultimate regulatory accountability
FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs — Quality Agreements (2016); EU GMP Part I Chapter 7 (Outsourced Activities)
Frequently asked questions
What is Quality Agreement?
A written agreement between a contract giver and contract acceptor — for example a sponsor and a contract manufacturer — that defines each party’s GMP responsibilities, quality expectations, communication pathways, and change-notification obligations for an outsourced manufacturing, testing, or packaging activity, separate from the commercial supply contract.
Which regulations cover Quality Agreement?
FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs — Quality Agreements (2016); EU GMP Part I Chapter 7 (Outsourced Activities)