Start with the right review package
Gather the executed BMR, its approved master reference and the associated records before reviewing individual entries. For each finding, record where the evidence sits, what needs clarification and who will resolve it. This makes a review easier to follow than a series of ticks without references.
This educational checklist uses US finished-drug-product requirements as a reference. Adapt it to the product, market and approved site procedures; it is not a complete release checklist for every manufacturing process. The examples below are illustrative, not reports of actual batches.
Six areas to check in a BMR
Open each area for the evidence to locate and an example finding. The record-content prompts draw on 21 CFR 211.188; investigation and approval prompts draw on 21 CFR 211.192.
1. Record identity and completeness
Match the batch record to its approved master, product and batch. Check the copy, dates, signatures and attached records.
Evidence to locate: Approved master reference, issued record and attachment index.
Example: The cover identifies batch A, but an attachment identifies batch B. Establish which batch the attachment belongs to and document the resolution; do not simply relabel it.
2. Materials and equipment traceability
Check component lot identification, quantities and the identity of major equipment used.
Evidence to locate: Dispensing entries, material references and equipment records.
Example: A material lot is readable on the dispensing record but absent from the manufacturing entry. Trace the original evidence and resolve the missing entry through the approved documentation process.
3. Processing and control results
Review significant processing steps, sampling, in-process results and laboratory references. Check who performed or verified the operations.
Evidence to locate: Executed process entries and linked test records.
Example: An in-process result is outside the approved limit, while the next step is signed complete. Locate the documented assessment and escalation rather than accepting the final test result as an explanation.
4. Yield and reconciliation
Check actual and theoretical yield at applicable stages. Recalculate the reported percentage and compare it with approved limits.
Evidence to locate: Recorded quantities, calculation basis and the applicable master-record limits.
Example: Illustration only: 96 kg actual output divided by 100 kg theoretical output gives 96%. That number alone does not establish acceptance; the approved limits and any discrepancy assessment govern the review.
5. Packaging and linked records
Where applicable, review packaging-area checks, labeling records, containers, closures and related examinations.
Evidence to locate: Associated packaging record, label specimens and reconciliation records.
Example: The BMR references a packaging record that is missing from the review set. Retrieve and verify the referenced record before treating the review package as complete.
6. Investigations and approval
Check that unexplained discrepancies and specification failures have documented investigations, conclusions and follow-up. Confirm quality-unit review before release or distribution.
Evidence to locate: Investigation references, associated-batch assessment and documented review decisions.
Example: A discrepancy is marked “resolved” with no investigation reference. Ask for the supporting assessment and conclusion; a status label does not explain the evidence.
Make each finding traceable
A useful review note identifies the record and page, the observation, the expected requirement, the evidence requested, the responsible person and the documented resolution. Use the approved site system to classify and manage the finding.
“BMR page 12 refers to test report QC-104, but QC-104 is not in the review set. Please provide the approved report and verify that its sample and batch identifiers match this record.”
This is more actionable than “QC document missing”: it identifies exactly what the reviewer needs to examine.
Do not invent missing data or silently replace an original entry. Use the site documentation and investigation procedures to resolve uncertainty. A completed checklist does not itself authorize release. Under the cited US requirement, the quality unit reviews and approves production and control records before release or distribution; unexplained discrepancies and specification failures require investigation, including assessment of potentially related batches.
Need the BMR issuance and control procedure?
This free guide concerns review of an executed record. The BMR Issuance and Control SOP covers requesting, authenticating, issuing, retrieving and retaining the record, with a requisition form and an issuance/retrieval log.
The Word package does not include this guide as a separate checklist or a product-specific master BMR.
View the editable BMR SOP package →References and related guidance
- 21 CFR 211.188 — Batch production and control records: record contents for US drug products.
- 21 CFR 211.192 — Production record review: quality-unit approval and investigation responsibilities.
- Good Documentation Practices SOP: related documentation template.
- Browse Quality Assurance SOP templates.
Read the current official text and confirm applicability. The examples and review-note structure are PharmaEdges explanations, not regulatory quotations or approval of a site procedure.