Risk Based Inspection (RBI) – Schedule M Point 34.14 (in the CDSCO RBI checklist) checks whether the Batch Packaging Record (BPR) for each batch covers all points required by WHO TRS 986 and PIC/S. CDSCO
What the inspector is verifying (intent)
Packaging is a high-risk step for mix-ups, mislabeling, and traceability failures. So, the BPR must prove that the correct bulk, correct packaging materials, correct coding, and correct checks were used—every time.
Core expectations for compliance
WHO TRS 986 states that a batch packaging record should be kept for each batch (or part-batch) and should be based on approved packaging instructions, with preparation designed to avoid errors. It also requires recorded evidence of line clearance before packaging, confirming the line is free from previous products/documents/materials and equipment is clean/suitable—and that these checks are recorded.
The BPR should also record, at the time activities occur, key details such as:
- product name, batch number, bulk quantity packed, planned vs actual packed quantity and reconciliation.
- dates/times of packaging, responsible persons and operator initials.
- identity checks and conformity with packaging instructions, including in-process control results.
What inspectors cross-check on the shopfloor
They commonly correlate BPR completeness with surrounding Schedule M controls, such as:
- BPR covers Schedule M points (34.13), and all packaging-generated documents are attached (34.15) CDSCO
- Packaging yield calculated immediately and independently verified, with deviations investigated (34.9–34.10) CDSCO
- BPR is based on the current master record (34.16) CDSCO
Typical non-compliances: missing reconciliation, missing line-clearance evidence, incomplete IPC records, uncontrolled attachments (coding samples/printouts), or outdated master version references—leading to a “not covered” outcome under 34.14.