In Schedule M (Part I), Point 2.6 sits under “Warehousing Area” and requires that rejected, recalled, or returned materials/products are segregated in storage, with the area/items clearly marked, secured, and access restricted to authorized persons.
Why Point 2.6 matters in Risk-Based Inspection (RBI)
A Risk-Based Inspection prioritizes inspection frequency, depth, and scope based on the estimated risk to patients and product quality and the firm’s compliance history. cdsco.gov.in
Within RBI, poor segregation controls are treated as a high-risk signal because they can directly cause:
- Mix-ups and unintended release (rejected/returned stock accidentally re-enters saleable inventory)
- Quality deterioration (returned goods stored improperly and later reused)
- Data integrity / traceability gaps (unclear status, missing disposition records)
- Recall failures (recalled lots not fully identified, isolated, or controlled)
What inspectors typically verify for Schedule M 2.6 (evidence expected)
Inspectors generally look for both physical controls and procedural controls, such as:
- Defined quarantine/reject/return/recall zones
- Dedicated cages/rooms/racks with signage and boundary marking
- If “electronic segregation” is used, evidence it gives equivalent assurance (system access roles, status blocks, audit trails).
- Status labelling and security
- Prominent “REJECTED / RETURNED / RECALLED / QUARANTINE” labels with material code, batch/lot, quantity, date, and status owner
- Locked access, key control, CCTV where justified, and controlled entry logs.
- Clear disposition workflow (QA-led)
- Written SOPs for evaluation of returns (saleable vs non-saleable), investigation triggers, and decision paths: re-test, rework/reprocess (if permitted), return-to-vendor, or destruction
- Documented final disposition approvals and reconciliation of quantities.
- Recall readiness integration
- Records proving recalled stock is rapidly identified, segregated, and prevented from movement; periodic mock recall results linked back to warehouse controls.
In RBI terms, weaknesses in Point 2.6 often expand the inspection scope into complaints, recall system, batch release controls, and inventory/data controls, because the segregation failure increases the probability of patient-impacting defects.