Risk-Based Inspection (RBI) is a GMP approach where regulators rate a site’s risk to patients and product quality and then decide the frequency, depth and breadth of inspection accordingly. cdsco.gov.in RBI site selection also considers signals like complaints, NSQ history, recalls, inherent product risk, inspection history, major changes, and staff competence.
Schedule M (Points 14.10–14.15): What they require
These clauses sit in Starting Materials / Receipt & Control and are critical because failures here can cause mix-ups, contamination, and wrong-material use.
- 14.10 Incoming material verification & labelling: Every incoming consignment must be checked against the order; containers cleaned where needed, labelled as required, and added labels must not hide original information.
- 14.11 Damage / issues investigation: Any container damage or other quality-impacting issue must be recorded, reported to QC, and investigated.
- 14.12 Multiple batches in one delivery: If a delivery contains different batches, each batch is treated separately for sampling, testing, and release.
- 14.13 Storage labelling minimums: Labels must include name/code, supplier batch + internal control batch (traceability), material status (quarantine/on-test/released/rejected/returned/recalled), and expiry/retest date where applicable (unless a fully validated computerized system justifies otherwise).
- 14.14 Use only QC-released, within shelf-life: Only raw materials released by QC and within shelf-life can be used.
- 14.15 Reduced testing for non-API raw materials (skip-lot concept): If non-API materials are released without batch-by-batch testing, it must be justified through vendor approval and statistical analysis of historical results.
How RBI inspects 14.10–14.15 (what inspectors actually test)
- Receipt-to-quarantine controls: GRN process, container cleaning practice, status labelling, segregation, and ERP controls preventing use before QA/QC release.
- Sampling integrity: who samples, where, how tools are cleaned, prevention of cross-contamination, and traceability from sample to container/batch.
- Damage investigations (14.11): deviation classification, root cause (transport/vendor/storage), impact assessment on other lots, CAPA, and supplier feedback loop.
- Label governance (14.13): readability, error-proofing, reconciliation, and whether electronic status systems are validated and match physical reality.
- Skip-lot/reduced testing robustness (14.15): written statistical plan, vendor performance trending, periodic full-testing frequency, change control triggers (new vendor/site/process), and immediate reversion to full testing after OOS/complaints/recalls—since these are RBI risk signals.