In a risk-based inspection (RBI), Schedule M points 8.16–8.17 are treated as high-severity safety and contamination-prevention controls because poor storage of solvents and inflammable materials can trigger fire/explosion, toxic exposure, environmental noncompliance, and product cross-contamination.
8.16 – Exterior storage for solvent storage area
Inspectors verify whether an exterior (outside-main-block) solvent storage area is available and used for bulk solvent drums/containers.
RBI focus is practical risk reduction: outside placement reduces ignition risk inside GMP areas and limits vapour spread. Inspectors typically check:
- Location & construction: separation distance from production/warehouse, controlled entry, weather protection, and suitable containment (bunding/curbing) for spills.
- Electrical/ignition control: appropriate electrical safety, no open flames, static control (bonding/grounding during transfer), and controlled vehicle/forklift movement.
- Ventilation & housekeeping: vapour control, clean drains, no leak stains, and spill kits available.
- Inventory discipline: approved list of solvents, FIFO/FEFO where applicable, container integrity checks, and traceability (receipt → issue → return/disposal).
8.17 – Storage area for inflammable materials
Inspectors confirm there is a dedicated storage area for inflammable materials (not mixed with general raw materials/packaging).
This expectation aligns with Schedule M’s requirement that flammable materials be stored in suitably designed, segregated, enclosed areas as per applicable legislation. Inspectors also cross-check that substances posing fire/explosion risks are in safe and secure areas with adequate fire protection measures.
What evidence RBI expects
- Layout drawings showing segregation and flow.
- SOPs for storage, dispensing/transfer, spill response, and emergency actions.
- Fire safety provisions (extinguishers/hydrants, signage), routine inspection logs, training records, and deviation/incident trending linked to CAPA.