STANDARD OPERATING PROCEDURE
Title Procedure For BMR, BPR Review and Release
- OBJECTIVE
- To define the procedure for review of Batch Manufacturing Record and Batch Packing Record.
- SCOPE
- This procedure applies to Quality Assurance Department.
- RESPONSIBILITY
- Officer / Executive – Quality Assurance
- ACCOUNTABILITY
- Manager – Quality Assurance
- PROCEDURE
- Executive – Production to review and ensure the compilation of all related attachments, basic data entry, completion of data and sign before submitting to the Manager-Production for verification.
- Manager-Production to review and confirm the completion of Batch Manufacturing Record (BMR), Batch Packing Record (BPR) and submit the BMR & BPR duly signed to IPQA – Executive.
- IPQA – Executive to attach the related IPQA reports verify the IPQA counter checks performed and submit the BMR & BPR along with verified Finished Product Release Report and Finished Goods Transfer Note (FGTN).
- Executive – Quality Assurance to obtain the completed analytical report and Certificate of Analysis (COA) and attach to the Batch record.
- Executive-Quality Assurance to review the whole Batch records (BMR/ BPRs), other related documents (Deviation form/ Investigation report, if any), Analytical reports, attachments (RM/PM Tags, Specimen coded samples of Packing material, etc.).
- Emphasis to be given on following during Batch records (BMR & BPR) review.
- General checks as per the BMR & BPR.
- Records are complete.
- Error-free coding details (Batch No., date of manufacture, Exp date, License No., MRP) in specimen coded samples.
- Tidy / Neat / Legible data entry.
- Precise / Accurate data.
- Timely entries.
- Deviation reports if any.
- Material reconciliation – Verification
- For regular / part batch – Completion
- Reject Material / Destruction – Verification
- IPQA Data entry – Verification
- Destruction Record – Verification
- Printed Labels and other packing
- material reconciliation – Verification
- Overprinting Matter – Verification
- Yield at all stages – Verification
- Environmental Parameter recording – Verification
- General checks as per the BMR & BPR.
- During review, corrections/deficiencies, if found, shall be filled in “BMR & BPR Review Deviations/ Deficiencies Form” as per Attachment I and II.
- Send back the BMR & BPR along with Deviations/Deficiencies form to Manager-Production for corrections.
- Executive – Production to ensure all the deficiencies corrected and indicate the action taken and action by in the Deviations/Deficiencies form.
- Manager -Production shall confirm the deficiencies and submit the corrected BMR & BPR to Executive-QA.
- Executive-QA to review the correction made and also obtains correction if any in analytical report from Manager-Quality Control.
- Submit the total batch records, IPQA reports, Analytical reports, attachments along with Finished Product Release Report & Finished Goods Transfer Note to Manager -QA.
- Manager -QA or his deputy to ensure.
- Completion of all documents.
- Compliance of all corrections.
- Compliance of all deviations/deficiencies.
- Yield analysis, reconciliation.
- Finally Manager -QA or his deputy to approve and sign the Finished Product Release Report & Finished Goods Transfer Note after complete review of batch documents.
- After complete review & compliance Manager -QA or his deputy shall issue the “Batch Release Certificate” as per format III.
- Archive the completed BMR docket in QA as per SOP and Record the Archival.
- ABBREVIATIONS
- QA – Quality Assurance
- SOP – Standard Operating Procedure
- BMR – Batch manufacturing record
- BPR – Batch Packaging record
- ATTACHEMNTS
| Sr. No. | Title | ATTACHMENTS |
| BMR Deviations / Deficiencies Form | ATTACHMENT-I | |
| BPR Deviations / Deficiencies Form | ATTACHMENT-II | |
| Quality Assurance Product Release Sheet | ATTACHMENT-III | |
| Quality Assurance Product Hold Sheet | ATTACHMENT-IV | |
| BMR & BPR Review Checklist | ATTACHMENT-V |
- DISTRIBUTION
| Sr. No. | Copy No. | Department |
| Quality Assurance | ||
| Quality Control | ||
| Quality Control – Microbiology | ||
| Production | ||
| Engineering & Utility | ||
| Personnel & Administration | ||
| Warehouse | ||
| VP-Plant & Operations |
ATTACHMENT-I
BMR DEVIATIONS / DEFICIENCIES FORM
Product :______________________ Batch No.:____________________
| Page No. | Deviations/ Deficiencies | Officer Responsible | Action taken | Action By | QA Review | Reviewed By |
Approved By :
Sign/Date : _______________
(Manager- QA /Designated deputy)
ATTACHMENT-II
BPR DEVIATIONS / DEFICIENCIES FORM
Product :______________________ BPR No.:___________________
Batch No.:______________________
| Page No. | Deviations/ Deficiencies | Officer Responsible | Action taken | Action By | QA Review | Reviewed By |
Approved By :
Sign/Date : _______________
(Manager- QA/ Designated deputy)
ATTACHMENT-III
PRODUCT RELEASE
| Product / Generic Name | : | ||||
| Batch No. | : | Batch Size | : | ||
| Mfg. Date | : | Exp. Date | : | ||
| Date of Sampling | : | Date of Release | : | ||
Date: Time:
Process Stage completed: Bulk/ Semi finish/ Semi finish (Coated)/ Finished
Status of Stage Completed: …………………………………… is released for further process on the basis of attached data (i.e. Bulk/ Semi finish / Semi finish (Coated)/ Finish)
All related documents in BMR/ BPR are verified and reviewed and found satisfied for further process stage.
| Description |
|
| Average Wt./ fill | |
| pH | |
| Assay |
Done By Checked By Released By
Officer / Executive QA Manager-QA
Sign./ Date Sign./ Date
ATTACHMENT-IV
| Quality Assurance Product Hold Sheet | |||||
| Product / Generic Name | : | ||||
| Batch No. | : | Batch Size | : | ||
| Mfg. Date | : | Exp. Date | : | ||
Date: Time:
Process Stage completed: Bulk/ Semi finish / Finish.
Status of Stage is Hold for further process on the basis of In-Process Quality Assurance Person the product is not complying as per specification.
All related documents in BMR/ BPR are verified and reviewed and found satisfactory / not satisfactory for further process stage.
Observation:………………………………………………………………………………………………..………………………
Prepared By Approved By
Officer / Executive QA Manager-QA
Sign./ Date Sign./ Date
ATTACHMENT-V
BMR & BPR REVIEW CHECKLIST
| Sr. No. | Document to be check |
Status |
Reviewed By |
| Batch Manufacturing Record | |||
| BOM Sheet of RM | |||
| Line Clearance For Dispensing | |||
| Dispensing Label of Raw Materials | |||
| Line Clearance For Manufacturing | |||
| Purified Water Report | |||
| Rinse / Swab Report | |||
| Manufacturing Process | |||
| QA In Process Check Record | |||
| Line Clearance For Compression/ Filling/ Coating | |||
| Bulk/ Semi-finish/ Coated Intimation Report | |||
| Manufacturing Yield Reconciliation Record | |||
| Batch Packing Record | |||
| BOM Sheet of PM | |||
| Dispensing Label of Packing Materials | |||
| Line Clearance for Packing | |||
| QA In Process Check Record | |||
| Specimen of Label / Foil | |||
| Specimen of Carton | |||
| Specimen of Shipper Label | |||
| Shipper Weighing Record | |||
| Finished Goods Transfer Ticket | |||
| Yield Reconciliation After Packing | |||
| Additional Materials Issuance Record | |||
| Material Return Note | |||
| On line Rejection Record | |||
| Finished Product Analysis Report ( COA ) | |||
| Change control/ Deviation (if any) | |||
| Terminal Inspection Sheet | |||
Remarks: (if any)…………………………………………………………………………………………………………………………….
Checked By Reviewed By Approved By
Officer-QA Executive-QA Manager-QA
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