Quick answer
Batch record review is where most cGMP execution defects are detected. A checklist-based review reduces release risk and documentation gaps.
Review checklist
- Component lot traceability and usage reconciliation.
- Actual weights and in-process test entries.
- Deviation documentation and disposition logic.
- Packaging/label reconciliation and release signatures.
Escalation thresholds
Define immediate escalation for identity-test failures, unresolved deviations, or missing sign-offs.
Audit readiness
Keep a batch review log with closure dates, reviewer names, and evidence links for each release.
Related links
cGMP guide, supplement playbook, ingredient checker results.
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