In a risk-based inspection (RBI), Schedule M – Point 2.4 (Warehousing area) is assessed as a high-severity mix-up and quality-gate control, because quarantine is the main barrier preventing unreleased/untested materials or products from entering manufacturing or dispatch.
Regulatory intent (what 2.4 requires): If a facility ensures quarantine status by keeping materials in separate earmarked areas within the same warehouse/store, those quarantine areas must be clearly demarcated. If a firm uses a system instead of physical quarantine (e.g., electronic status control), that system must provide equivalent assurance of segregation, and access to quarantine areas must be restricted to authorized persons.
How inspectors apply RBI (what they actually test)
1) “Walk the lot” traceability test: Inspectors pick a recent incoming RM/PM lot and trace receipt → quarantine → sampling → QC testing → QA release → issuance. Any ability to bypass quarantine is treated as a critical risk. CDSCO
2) Physical demarcation effectiveness: They verify quarantine is not just a signboard—there should be physical separation (cages/lines/barriers), status labels, controlled movement routes, and no “temporary parking” of materials in released zones.
3) Equivalent electronic quarantine (if used): RBI checks whether the WMS/ERP has robust controls: unique location mapping, barcode scanning, system blocks preventing picking/issuing of quarantine lots, audit trails for status change, and QA-only authorization. The inspector looks for evidence that “system quarantine” is truly equivalent to physical segregation.
4) Access restriction and security: Inspectors confirm restricted entry (locks, access logs, CCTV where applicable), defined authorized roles, and training. Unauthorized access or shared keys is a red flag.
5) Deviations and CAPA: They review incidents of wrong issuance, status mislabeling, or inventory discrepancies and whether CAPA prevented recurrence—because repeated quarantine failures indicate loss of control.