Batch Manufacturing Records Review

Batch Manufacturing Records Review

Check all sections of the Batch Manufacturing Record (BMR), for the accuracy and correctness of the information recorded.

Check that each operation is performed and recorded in full compliance with the issued Batch   Manufacturing Record and in accordance with the approved procedure.

Verify entries made on documents of BMR by counter-checking all the related Raw data for Accuracy

Check the incidents/deviations (if any) for proper documentation, and investigation of any non-conforming in-process events/out-of-specification results.

Check the correctness and completeness of the BMR as per the ‘Checklist for Quality Assurance review of BMR’ (Attachment-1) and sign with Date.

In the event of the absence of specific document(s) or incorrect or incomplete entries made on any document, or incomplete investigation reports of deviations; shall be notified to the person responsible and the Head of Production department for appropriate action.

After the BMR  is found to be complete and satisfactory in all respects, Officer – QA shall sign with the date on “Checklist of BMR Review”.

The Checklist for BMR review shall be attached with the respective BMR.

Checklist for BMR Review

BMR is an accurate reproduction of current Master Manufacturing Record

All the issued pages are available

Dispensing Sheet for Raw Material

Batch Planning Sheet ( for Dispensing of Raw material & Packing Material)

Dispensing Sheet for Packing Material

Dispensing  labels for Raw Material

Area cleaning and Line Clearance Record

Manufacturing Instructions: All manufacturing instruction followed and accurately documented with respect to equipment used, mixing, drying, loading and

Blending time, etc., with sign. and date.

In-Process check  records (Tablet Compression/Capsule Filling/Tablet Coating/Liquid Filling/Sachet Filling, etc.)

Stage wise yield and reconciliation

Packaging  Instructions: All packaging instruction steps filled out referencing equipment used, quantities Packed, Signed and dated.

The expiry date is assigned correctly and mentioned in all packaging records.

Specimen of coded labeling and literature.

In-process checks during packing  operation

Sample collection record

Labels and packaging material reconciliation record

Stage Wise of analytical report.

Review of Finished product analytical records/other analytical records if any.

Finish product release report

Any deviations/Incidents are appropriately documented, investigated, and disposed of.