Risk-Based Inspection (RBI) – Schedule M Point 14.1 (Raw material records as per Schedule U)
In RBI, inspectors plan the depth and sampling of an inspection based on risk to patient/product quality and compliance signals, so material-management controls are always prioritized because a wrong/contaminated raw material can compromise the entire batch. CDSCO Schedule M inspection checklists capture this under Raw Materials – 14.1: “whether the records of raw materials are maintained as per Schedule U.”
What Schedule U expects in raw material records (core compliance)
Schedule U requires records for each raw material showing, at minimum: date of receipt, invoice number, name and address of manufacturer/supplier, batch number, quantity received, pack size, date of manufacture, date of expiry (if any), date of analysis, QC release/rejection decision, analytical report number (plus special remarks if any), quantity issued, date of issue, and the product name and batch number(s) for which it was issued, including proper disposal of stocks. These records must be available for inspector review, and the rules specify retention expectations (commonly five years from date of manufacture for the test records/registers referenced to Schedule U).
How RBI verifies 14.1 (what inspectors actually do)
RBI does not stop at “a register exists.” Inspectors typically:
- Traceability test (end-to-end): pick 2–3 finished-product batches and trace every key raw material back to its Schedule U record (receipt → QC release → issue to that batch).
- Data integrity checks: confirm entries are contemporaneous, attributable, and consistent (no unexplained overwriting; analytical report numbers match QC files).
- Cross-check physical vs paper: verify stock quantities, container labels/status, and locations align with the record (including partial containers and returns).
- Risk-based sampling: increase sampling for high-risk materials (potent APIs, allergens, microbiologically sensitive excipients, high-volume materials, new suppliers, or recent deviations/complaints).
- Disposition and disposal evidence: confirm rejected/expired/returned material handling and documented disposal match the “proper disposal” requirement.
Common RBI gaps: missing supplier/batch traceability, QC “release” recorded without supporting lab data, issuance not linked to product batch numbers, and stock adjustments without investigation—each raises mix-up and contamination risk under Schedule M 14.1.