Review of Batch Production Records
OBJECTIVE :
To provide a procedure for the review of the Batch production records (BPR) before releasing drug products, in order to verify compliance with cGMP requirements and all established specifications and written procedures in the manufacturing of the product batch.
RESPONSIBILITY :
Quality Assurance Officer.
Head of Quality Assurance Department to ensure compliance.
PROCEDURE :
Officer – Quality Assurance shall :
Check all sections of the Batch Production Record (BPR), for the accuracy and correctness of the information recorded.
Check that each operation is performed and recorded in full compliance with the issued Batch Production Record, and in accordance with approved procedures.
Verify entries made on documents of BPR 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 BPR as per the ‘Checklist for Quality Assurance review of BPR’ (annexure-1) and sign the same.
In the event of the absence of specific document(s) or incorrect and incomplete entries made on any document, or incomplete investigation reports of deviations shall be notified to the person responsible and the Head of the Production department for appropriate action.
After the BPR is found to be complete and satisfactory in all respects, Officer – QA shall sign with the date on each page of the BPR.
The Checklist for review of BPR shall be filed with the respective BPR.
Forms and Records (Annexures)
Specimen format of “Checklist for Quality Assurance review of BPR” – Annexure-1
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control, engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Annexure-1
CHECKLIST FOR QUALITY ASSURANCE REVIEW OF BPR
Product Name:___________________Batch No. :__________________Batch size:
Item to be checked
- BPR is an accurate reproduction of the current Master Production Record
- All the issued pages are available ‘Checked and Issued ‘ by columns at the top of each PO-RM, PO-PM are
- signed, dated by concerned personnel Batch # mentioned correctly on all pages.
- Adjustment of Quantity of Active ingredient as per instruction.
- Production order raw material
- Weighing Record of raw materials
- Material details labels
- Area cleaning and clearance checklist
- ‘Equipment Cleaned Type A/B/C” labels
- Equipment Clearance checklists.
- BPR Manufacturing Instructions: All
- manufacturing instruction followed and
- accurately documented with respect to
- equipment used, mixing, drying, loading and blending times, etc., with a sign. and date.
- Product labels, printouts of equipment (if applicable)
- Environmental conditions are within the limit
- In-Process check records during tablet compression/ capsule filling.
- In-the process check records during the coating Stage-wise yield and reconciliation
- Production order packaging material
- Packaging material weighing record
- Packaging area cleaning and clearance checklist
- BPR – Packaging Instructions: All packaging instruction steps filled out referencing equipment used, quantities
- Packed, Signed, and dated.
- The expiry date was 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
- Summary statement of Batch yield for Tablets /Capsules
- Review of analytical records during blending.
- Review of analytical records of core tablets / Coated tablets / Filled capsules.
- 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.
