In a risk-based inspection (RBI), Schedule M points 2.2 and 2.3 are assessed under warehousing and material movement controls, because weak storage/receiving practices can lead to temperature/humidity damage, contamination, mix-ups, and use of unreleased materials—all of which directly impact patient safety and batch disposition. The RBI approach prioritizes sites/materials with higher patient risk and poor compliance history. CDSCO
Schedule M 2.2 – Warehousing areas
2.2 requires warehousing areas to be designed and adapted for good storage conditions, kept clean and dry, maintained within acceptable temperature limits, and—where special conditions are needed (e.g., temperature/humidity)—these must be provided, monitored, and recorded. It also expects housekeeping and pest/rodent/vermin control procedures with records, and adequate racks/bins/platforms for storage.
RBI focus: inspectors verify the “system works” by reviewing:
- mapping of storage zones (quarantine/released/rejected/returned), access control, and clear status labelling
- continuous temperature/RH monitoring (where applicable), alarm handling, excursions, and product impact assessment
- FEFO/expiry controls, sampling controls, cleaning schedules, and pest trend reports
- special-risk materials (cold-chain items, printed packaging, potent/sensitising materials) handled with stronger segregation and reconciliation controls
Schedule M 2.3 – Receiving and dispatch bays
2.3 expects receiving/dispatch bays to protect materials and products from adverse weather conditions.
RBI focus: inspectors check whether inbound/outbound movement prevents deterioration and mix-ups:
- covered docks, controlled staging areas, and segregation of incoming vs dispatched goods
- receipt checks (damage, seal integrity, COA/traceability), quarantine controls before QC release
- dispatch verification (correct item/batch/quantity), transport qualification where temperature control is required, and handling of returns
These controls align with WHO GMP expectations that storage of starting materials and finished products is a key GMP compliance element and should be routinely evaluated.