SOP for BMR and BPR review

In short: This is an illustrative standard operating procedure (SOP) for reviewing draft and completed batch manufacturing records (BMRs) and batch packing records (BPRs). It is for QA, production, packing and QC teams. Adapt the roles, checkpoints and escalation path to the approved documents and quality system at your site.

Template notice: This is not an approved site SOP. Role assignments and checklist items below are examples in-house criteria; review and approve them under your own quality system before use.

1. Objective

To describe an example process for checking draft BMRs and BPRs before issue, and for reviewing completed records after manufacture or packing.

2. Scope

This example covers batch records used for pharmaceutical manufacture and packaging. It can be adapted for paper, electronic or hybrid records. Follow the applicable product authorization, site procedures, and current regulatory requirements.

3. Responsibilities

The role titles below are example in-house criteria. Assign the actual responsibilities and approval authorities in the site’s quality system.

4. Procedure

4.1 Prepare for review

Use the current controlled copy of the record and the approved source documents relevant to the product and operation. Confirm the record version and its relationship to the applicable manufacturing formula, packaging instructions, specifications, material list and change-control records. Ensure that reviewers have the procedures and training needed for their assigned tasks.

4.2 Review a draft BMR or BPR

The following checkpoints are example in-house criteria. Select and adapt the checks needed for the product, process and market.

• Confirm that the product name, strength or presentation, batch size, record number and version agree with the approved source documents.
• Check that each process or packaging step is in the intended sequence and that instructions are clear to the people who will perform the work.
• Check that materials, equipment, process controls, sampling and tests are consistent with the approved documents.
• Confirm that the record provides suitable fields for entries, dates, signatures or electronic attribution, results, reconciliations and references to attachments.
• Check that planned yields, limits and other acceptance criteria match the approved source documents. Do not create or change site limits through this review checklist.
• Confirm that proposed changes have the required assessment and approval before the record is issued.

Additional example checkpoints for a draft BMR

These questions can be used when building a site checklist. They do not set process values or replace review against the approved product documents.

• Product and batch details: Are the product name, dosage form, strength, batch size, manufacturing site and record version consistent across the cover, formula and linked documents?
• Materials and quantities: Does the materials list identify the approved materials and units of measure? Are amounts, potency adjustments or overages included only where the approved formula requires them?
• Equipment and process flow: Are the equipment types and processing stages appropriate for the approved process? Does the order of steps make it clear when material moves between operations?
• Instructions and entries: Are instructions distinct from fields where the operator records actual work? Is there a clear place to document relevant dates, times, observations and review signatures or electronic attribution?
• Process controls: Are in-process checks, sampling points, test methods and acceptance criteria linked to approved specifications or procedures? Does the record identify where results are entered and reviewed?
• Materials status: Are required status checks and references to material issue or test records represented in the draft where the site procedure requires them?
• Yield and reconciliation: Are expected yields or reconciliations included only when established in approved source documents, with room to record actual results and investigate discrepancies?
• Attachments: Does the draft identify forms, worksheets, equipment logs or reports that must accompany the completed batch record?
• Special handling: Are product or process precautions included when supported by the approved instructions, risk assessment or product information?
• Change history: Can the reviewer identify the current effective version and the approved change that introduced a revision?

Additional example checkpoints for a draft BPR

All the following are example in-house criteria. Adapt them to the packaging operation and the approved packaging instructions.

• Confirm the product presentation, pack size, batch reference and BPR version against the approved packaging specification.
• Check that the bill of materials identifies each required packaging component and its approved code or specification reference.
• Ensure that the controlled text or approved artwork reference for printed components can be identified without copying uncontrolled artwork into the SOP.
• Confirm that the instructions describe the required line-clearance and product-identification checks at the appropriate points in the operation.
• Check that coding and variable data have a place for recording and verification in accordance with the approved instruction.
• Confirm that in-process inspection and testing steps refer to approved procedures and provide fields for results and review.
• Ensure that component issue, use, return, rejection or destruction can be reconciled where required by the approved process.
• Check for space to document line stoppages, packaging deviations and their assessment without obscuring the original record.

Document draft comments, return the record for correction where needed, and complete a final review before routing it through the site’s approval process. Control superseded versions to prevent unintended use.

4.3 Review an executed BMR

The checkpoints below are example in-house criteria, not a universal regulatory checklist:

• Confirm that the record identifies the product and batch and that required pages and attachments are present and traceable.
• Review entries for completeness, readability and attribution. Check that corrections preserve the original entry and follow the site’s record procedures.
• Compare material identities, batch numbers and recorded quantities with the approved instructions and supporting records.
• Check that manufacturing steps, equipment identifiers, in-process results and required checks are recorded against the approved instructions.
• Review deviations, investigations and approved changes referenced in the record. Confirm that their impact and disposition are documented through the relevant procedures.
• Check recorded yields and reconciliations against approved criteria and confirm that unexplained discrepancies were assessed.
• Document observations, reference the affected page or record location, and track correction and review to closure under the site procedure.

4.4 Review an executed BPR

These checks are example in-house criteria and should be adapted to the packaging process and approved instructions:

• Confirm product, batch, presentation, packaging record version and packaging dates or stages are identified.
• Review line or equipment status checks and packaging in-process controls against approved instructions.
• Reconcile issued, used, returned and rejected packaging components where the approved record requires it.
• Check that printed materials, batch coding and expiry information were verified according to the approved packaging instructions.
• Review recorded deviations, changes, rejected units and other discrepancies, including their documented disposition.
• Check that observations from earlier record review were addressed and that referenced attachments are present.

4.5 Document observations and complete review

Record each observation in the approved review form or electronic workflow. Identify the affected record location, describe the discrepancy clearly, and route it to the responsible function for assessment. Corrections and investigations must follow the site’s approved procedures; reviewers should not erase, obscure or silently amend executed entries.

Complete the review record with the reviewer’s identity, date and outcome, as defined by the site procedure. Batch disposition remains with the authorised role identified in that procedure and applicable requirements. Keep the reviewed record and supporting documentation under the established document-retention controls.

5. Abbreviations

References

• European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Chapter 4: Documentation, revision 1, January 2011. Sections 4.20 and 4.21 describe batch processing and packaging record content in the EU GMP context. Official PDF.
• Central Drugs Standard Control Organization, Government of India. G.S.R. 922(E): Notification of Schedule M of the Drugs Rules, 1945, 28 December 2023; G.S.R. 666(E): Corrigendum to G.S.R. 922(E), 25 October 2024. Check applicable current requirements and later notices in the CDSCO Gazette Notifications.

Related reading

• Good documentation practices for BMRs, BPRs and production records
• Control of documentation
• SOP for batch release of finished product

Frequently asked questions

Who should review a BMR or BPR?

The site’s approved procedure should identify reviewers and approvers. The roles in this article are examples in-house criteria and may not match every site’s organisation.

Should draft and executed records use the same checklist?

They have different purposes. Draft review checks that the controlled instructions are complete and consistent before issue; executed-record review checks the evidence and entries recorded during the batch.

What should happen when a reviewer finds a discrepancy?

Record the observation, identify where it occurred and route it through the site’s approved correction, deviation or investigation process. Do not alter an executed entry outside that process.

Does this template set mandatory BMR or BPR checkpoints?

No. It is an illustrative template. Use applicable regulations, product authorizations and approved site procedures to determine the actual controls and responsibilities.