Quality Agreement
The written agreement defining who is responsible for which GMP activity between the contract giver and the contract acceptor — release, change control, deviations, audits and recalls.
Why it is signed before the first batch
Regulators hold the marketing authorisation holder responsible for the contract site's compliance. The agreement is how that responsibility is exercised: notification timelines for deviations, change approval rights, audit access and complaint handling.
What it should never be
A commercial supply agreement with a GMP paragraph. The quality agreement is a separate, technical document owned by QA on both sides.
Related terms
Where this applies
Contract Manufacturing
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