A contract laboratory or contract manufacturer continues work after its quality agreement lapsed.
Step-by-step process flow:
The agent
Compares agreement validity dates with purchase orders, test requests and receipts.
Release, certify or disposition a batch
Close a deviation, investigation or CAPA
File anything with an authority
Write to your systems outside the transitions you approve
Send a message without a named person's approval
Contact a regulatory authority or a customer
Promote itself to a higher autonomy level
Make you compliant. Compliance decisions and accountability stay with you.
REVIEW AND REGULATION
Regulation
21 CFR 211.22 and FDA guidance Contract Manufacturing Arrangements for Drugs: Quality Agreements; EudraLex Volume 4, Part I, Chapter 7.
What does the agent do for testing labs and contract manufacturers on lapsed agreements?
The agent compares agreement validity dates with purchase orders, test requests and receipts.
Does the agent make the decision?
No. The agent prepares the finding and a named person decides. The agent never releases, certifies or dispositions a batch, never closes a deviation, investigation or CAPA, and never files anything with an authority.
Which regulations apply?
21 CFR 211.22 and FDA guidance Contract Manufacturing Arrangements for Drugs: Quality Agreements; EudraLex Volume 4, Part I, Chapter 7.
Send an export for one batch or lot and see the workspace run on your own data.
