Procedure For BMR,BPR Review and Release

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

Remarks: (if any)…………………………………………………………………………………………………………………………….

    Checked By                                     Reviewed By                                       Approved By

Officer-QA                                        Executive-QA                                         Manager-QA

 

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