1. OBJECTIVE
To lay down the procedure for review of Batch Manufacturing Record
2. SCOPE
This procedure is applicable in manufacturing facility
3. RESPONSIBILITY
• Officer QA
• Manager QA
4. SAFETY INSTRUCTIONS
• N/A
5. PROCEDURE
5.1 Head production/ Deputy should ensure the completion of all batch documents before submitting to QA.
5.2 Completed batch document duly signed by production manager along with IPQA data, finished product release report, finished good transfer note and other related data if any to be sent to QA.
5.3 Authorized person in QA will receive, review the BMR thoroughly and record entries as per SOP.
5.4 Any discrepancy in process, equipment and yield or parameters which may have an impact on yield/ quality/ safety of drug product should be critically examined.
5.5 Photocopies of Deviations and OOS should be attached along with BMR.
5.6 Emphasis to be given on following during BMR review.
5.6.1 General Checks as per check list but checks are not limited to following:
5.6.2 Records are submitted timely to QA completion of batch.
5.6.3 Error free coding details (Batch No., Mfg. Date, Exp. Date, Mfg. License No., MRP etc.).
5.6.4 Tidy/ Neat/ Legible
5.6.5 Correction/ Overwriting (if any duly signed and dated)
5.6.6 Timely entries
5.6.7 Deviation reports if any
5.6.8 Signature
5.6.9 Completion
5.6.10 Verification
5.6.11 Material reconciliation
5.6.12 For regular/ part batch – completion
5.6.13 IPQA data – Verification
5.6.14 Destruction note – Verification
5.6.15 Label reconciliation – Verification
5.6.16 Overprinting matter – Verification
5.6.17 Yield at all stages – Verification
5.6.18 Q.A and Regulatory affairs shall ensure:
5.6.18.1 Completion of all documents
5.6.18.2 Compliances of all corrections
5.6.18.3 Compliances of all deviations
5.6.18.4 Yield analysis
6. RELATED DOCUMENTS
Check List for BMR- Annex.1
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Quality Control Department | 01 | , |
| Production Department | 01 | , |
| Warehouses | 01 | , |
8. ABBREVIATIONS
Q.A Quality Assurance Department
BMR Batch Manufacturing Record
IPQA Inprocess Quality Assurance
OOS Out of Specifications
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 10/08/2022 | 00 N/A | First Version |