Quality agreement
The written agreement between a product owner and a contract facility that sets out each party’s GMP responsibilities.
FDA’s 2016 guidance on contract manufacturing arrangements describes quality agreements as defining who does what: who approves changes, who investigates deviations, who releases batches and how quickly each party must notify the other. Chapter 7 of EU GMP covers the same ground.
Notification terms only work if someone notices the event.
Where it goes wrong
Events that trigger a notification come up on a call or in a cover email, and the clock runs before anyone acts.
What Spurby does
Recognises events that trigger the agreement’s notification terms, and alerts the right people on both sides.
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