In a risk-based inspection (RBI), Schedule M points 8.21–8.24 are assessed as packaging mix-up and contamination controls, because failures with labels/foils/leaflets can directly cause wrong product identity, wrong batch/expiry, wrong cautions, and costly recalls.
8.21 – Control of labels, cartons, boxes, circulars, inserts and leaflets
Inspectors verify how printed components are controlled end-to-end: approved artwork/version control, secure storage with restricted access, clear status labeling (quarantine/released/rejected), controlled issuance to the line, and strict reconciliation at batch end. RBI focuses on high-risk SKUs (look-alike packs, multiple strengths, shared lines). Strong systems prevent loose components and ensure only one batch’s materials are present at the line at a time. CDSCO
8.22 – Records of receipt of all labelling and packaging materials
Inspectors check whether receipt records are complete and traceable: supplier name, item code/artwork version, quantity received, COA/print proof checks, QC/QA acceptance, and linkage to purchase order and batch usage. RBI emphasis is on data integrity and “one-to-one” traceability from receipt → release → issue → reconciliation → destruction/return. CDSCO
8.23 – Unused packaging materials: return to store or destroyed
Inspectors verify a defined, documented decision route: what can be returned to store (typically non-printed or controlled printed items if allowed), what must be destroyed, who authorizes it, and how reconciliation discrepancies are investigated before batch release. Evidence includes return notes, destruction logs, witness signatures, and deviation/CAPA for abnormal losses.
8.24 – Control of returned/unused foils to prevent contamination/cross-contamination
Foils are high risk because they may carry product residues and can contaminate subsequent batches if reused. RBI checks segregation of used/unused foils, closed labeled containers, defined acceptance criteria for returns (if permitted), cleaning/handling controls, and mandatory destruction where reuse creates contamination risk.