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

•  DISTRIBUTION

ATTACHMENT-I

BMR DEVIATIONS / DEFICIENCIES FORM

Product :______________________                         Batch No.:____________________

Approved By   :

Sign/Date        : _______________

(Manager- QA /Designated deputy)

ATTACHMENT-II

BPR DEVIATIONS / DEFICIENCIES FORM

Product :______________________                    BPR No.:___________________

Batch No.:______________________

Approved By   :

Sign/Date        : _______________

(Manager- QA/ Designated deputy)

ATTACHMENT-III

 PRODUCT 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.

  Done By                          Checked  By                                           Released By

Officer / Executive QA                                                                        Manager-QA

Sign./ Date                                                                                          Sign./ Date

ATTACHMENT-IV

 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

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

    Checked By                                     Reviewed By                                       Approved By

Officer-QA                                        Executive-QA                                         Manager-QA

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