Risk Based Inspection (RBI) – Schedule M Point 1.1 in the CDSCO RBI checklist asks inspectors to confirm whether the entire manufacturing facility is separated, dedicated, and not part of any other non-drug facility. CDSCO
Why this point is “risk-based”
If a drug site shares premises with non-drug activities (e.g., nutraceuticals, cosmetics, food, chemicals), the risk increases for:
- mix-ups (materials, labels, documents, people flow),
- cross-contamination (dust/aerosols, shared air handling, shared washing areas),
- data integrity and traceability gaps (shared stores, uncontrolled issuance),
- and weak enforcement of “drug GMP only” discipline.
Schedule M also states that manufacturing premises should be used exclusively for production of drugs and no other manufacturing activity should be undertaken there.
What inspectors typically verify under Point 1.1
1) Physical and functional segregation
- Separate buildings/blocks or clearly segregated areas with controlled access.
- Distinct personnel/material movement routes, airlocks (where applicable), and signage.
2) Shared systems check
- No uncontrolled sharing of HVAC/AHUs, dust extraction, washing areas, drains/effluent lines, utilities, or waste routes that could allow cross-contamination.
- Separate storage for drug materials vs any other materials (if any activity exists nearby).
3) Documentation and licensing evidence
- Manufacturing license scope matches the facility use; layout drawings and area classification reflect drug-only operations.
- SOPs proving segregation controls, line clearance, cleaning, pest control, waste handling, and security/access control are implemented.
4) Shopfloor verification
- Inspectors look for “real life” evidence: no non-drug stocks, no non-drug labeling/artwork, no mixed change rooms, no shared packing without segregation.
Common non-compliances
- Nutraceutical/non-drug packing in the same block, shared warehouses, shared AHU with sterile/support areas, or “temporary” non-drug storage—any of which can lead to an adverse RBI observation under 1.1.