A BMR (Batch Manufacturing Record) and BPR (Batch Packaging Record) checklist ensures each batch is made and packed exactly as approved, with complete traceability, GMP compliance, and data integrity. Below is a practical checklist used by QA/Production/Packaging.
BMR Checklist (Manufacturing)
Document control
- Current approved master (MBMR) version, effective date, page numbers, controlled copy status
- Product name, strength, dosage form, batch size, BMR/BMR No., batch no., planned dates
Materials & dispensing
- Raw/packing materials list with item codes, specifications, approved status
- Weighing/dispensing entries: actual quantities, balance IDs, calibration status, double-check signatures
- RM container/lot numbers, expiry/retest dates, reconciliation and yield calculation
Equipment & area
- Line/area clearance records (before start)
- Equipment IDs, cleaning status labels, cleaning record references, usage logbook entries
- Critical utilities checks (compressed air, vacuum, PW/WFI where applicable)
Process execution
- Step-by-step manufacturing instructions followed, with start/stop times
- CPPs recorded: temperature, mixing speed/time, granulation endpoints, drying LOD, compression parameters, coating parameters, etc.
- In-process controls (IPQC) results with acceptance criteria and approvals
- Hold times and environmental conditions recorded (if applicable)
Sampling & QA controls
- Sampling plan followed (in-process and finished), sample IDs, quantities, locations
- Any reprocessing/rework documented with approved justification and QA authorization
Deviations and investigations
- Deviation numbers, impact assessment, immediate action, QA disposition
- Change controls referenced if any planned change occurred
Yield & reconciliation
- Theoretical vs actual yield at key stages; acceptable loss limits
- Material reconciliation (RM/PM), rejects/scrap recorded and disposed per SOP
Signatures & data integrity
- Operator, checker, supervisor, QA signatures with date/time
- Corrections done as per GDP (single line, reason, sign/date; no overwriting)
BPR Checklist (Packaging)
- Approved artwork and coding details; line clearance; PM issuance and reconciliation
- Online checks: print/vision, barcodes, leak tests (if applicable), weight checks
- Finished pack count, rejects, sample retention, shipper labeling, final QA release checklist
This checklist supports right-first-time documentation and smooth batch release.