Procedure For BMR,BPR Review and Release

January 6, 2021 Reshma Verma SOPs 0

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

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