STANDARD OPERATING PROCEDURE
Title Procedure For BMR, BPR Review and Release
OBJECTIVE
To define the procedure for review of the 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
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 |
| BMR Deviations / Deficiencies Form | |
| BPR Deviations / Deficiencies Form | |
| Quality Assurance Product Release Sheet | |
| Quality Assurance Product Hold Sheet | |
| BMR & BPR Review Checklist |
- DISTRIBUTION
Quality Assurance
Quality Control
Quality Control – Microbiology
Production
Engineering & Utility
Personnel & Administration
Warehouse
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 |
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:………………………
ATTACHMENT-V
BMR & BPR REVIEW CHECKLIST
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