In a risk-based inspection (RBI), Schedule M and WHO TRS 986 coverage for 13.2–13.5 is evaluated as two linked risk themes: (1) prevention of label/printed material mix-ups (direct patient harm) and (2) prevention of errors/contamination from equipment and services (direct product quality impact).
Schedule M 13.2–13.5 (Labels & other printed materials) targets the highest-impact failure mode: the wrong label/leaflet being used during packing. Inspectors verify that printed packaging materials and product leaflets for different products are stored separately (segregation, secure storage, access control) to avoid mix-ups. They confirm QC examination/approval of all labels, cartons, boxes, inserts and leaflets before release, and that only the current approved version is issued to the packaging line. Before packaging/labeling, inspectors check evidence that the bulk is sampled, tested, approved and released by QC, so unapproved bulk cannot be packed. Finally, they review receipt and control records for each shipment of labels/packaging materials (receipt, control reference numbers, accepted/rejected status) and the documented destruction of unused coded/damaged labels to prevent unintended reuse. IPA Pharma
WHO TRS 986 13.2–13.5 (Equipment) checks whether engineering controls reduce human error and contamination risk: equipment must be installed to minimize risk of error/contamination; fixed pipework must be clearly labelled for contents and (where applicable) flow direction; service pipework/devices must be marked with emphasis on non-interchangeable connections/adaptors for dangerous gases/liquids; and balances/measuring devices must be of suitable range/precision and calibrated to a fixed schedule. ECA Academy
RBI evidence typically includes line-clearance and label reconciliation, approved artwork control, QC release checks, receipt/destruction logs, pipework ID maps, calibration certificates, and deviation/CAPA. High-risk red flags: loose-label handling without reconciliation, missing pipe labels/flow arrows, interchangeable gas hookups, and overdue calibrations.