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.