In a risk-based inspection (RBI), Schedule M point 2.1 (Warehousing area) is assessed as a mix-up and quality-preservation control, because storage weaknesses can trigger wrong-material use, status errors (quarantine vs released), deterioration, contamination, and recall failures. Point 2.1 requires adequate areas to allow sufficient and orderly warehousing of different categories: starting and packaging materials, intermediates, bulk and finished products, materials/products in quarantine, released, rejected, returned or recalled, plus spare parts and change items.
How inspectors apply RBI (what they test on the floor):
- Status segregation works in practice: clear physical/visual separation (and access control) for quarantine/released/rejected/returned/recalled. Inspectors trace one incoming lot from receipt → quarantine → sampling/testing → release → issuance, checking that no “shortcuts” bypass QA/QC release.
- Space and layout prevent mix-ups: sufficient aisle space, defined locations, bin/rack IDs, and “one location–one item” discipline so materials cannot be stored temporarily in wrong zones. Inspectors focus on look-alike containers, multiple strengths, and similar packaging components (highest mix-up risk).
- Printed packaging material control: heightened checks for labels/cartons/leaflets—restricted access, locked cages (where applicable), reconciliation-friendly storage, and strict segregation from rejects/returns.
- Risk-based storage for special materials: cold-chain/controlled temperature, hygroscopic, flammable, potent/toxic materials—verified by mapping, monitoring records, alarms, excursions, and impact assessments.
- Spare parts/change parts control: inspectors confirm spares and change parts are stored to prevent wrong part use (which can cause batch failures), with identification, cleanliness, and (where needed) line-clearance controls before returning to production.
RBI also aligns with CDSCO’s guidance intent: inspection depth increases where patient risk is higher and where past deviations/complaints indicate weaker control.