Batch Manufacturing Record (BMR) Management

Standard Operating Procedure for Preparation, Checking, Approval, authorization & issuance of Master Formula Record, Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR).

Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR)  Management

1.0   Objective :

• • To lay down the procedure for Preparation, Checking, Approval, authorization & issuance of Master  Formula Record (MBR), Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR).

2.0   Scope :

• • This SOP is applicable at pharmaceutical drug manufacturing plants.

3.0   Responsibility :

4.0   Procedure – Batch Manufacturing Record (BMR) Management

• • Content of Master Formula Record (MFR)

  • MFR shall contain the steps of manufacturing & primary packing to provide the guidance for preparation of BMR & BPR.
  • The Master Formula Record shall be prepared in approved format.
  • The format of MFR will be valid as per old format & shall be revised with new format when there is any change.
  • The MFR shall have the following details but not limited to:
    • General Information
    • Pre-Manufacturing controls and Precautions
    • Weighment Sheet of Raw Materials
    • Details of Packing Material
    • List of Equipments
    • Flow Charts
    • Dispensing of Raw Materials
    • Manufacturing Process
    • Packing Process
    • Quality Checks
    • Revision history

  • Content of the Batch Manufacturing Records (BMR)

  • BMR shall contain the steps of manufacturing as stated in the Master Formula records with
    provisions for recording the time of performing the activity and signature of the responsible
  • The Batch Manufacturing Record shall be prepared on approved format i.e. Annexure- II for
    own product & LL product.
  • The format of Batch Manufacturing Record (BMR) will be valid as per old format & shall be revised with new format when
    there is any change.
  • The BMR shall have the following details:
    • Cover page shall have the complete details of product being manufactured.
    • Check list
    • Raw material dispensing & weighing records.
    • Calculation for quantity of active ingredient(s) according to their assay & LOD/water.
    • Line clearance provision.
    • Complete stage wise details of manufacturing operation.
    • Release details for packing.
    • Yield calculation
    • Specimen signature log as per Annexure-V.

Remarks: For existing documents Annexure-V shall be issued till next revision of respective BMR.

• • Batch Manufacturing Record (BMR) contains manufacturing activities for tablets like –
    • Drying,
    • Mixing,
    • Granulation,
    • Compression,
    • Coating and
  • Inspection process with the provisions of recording time of performing activity and initial of the responsible person.
  • Batch Manufacturing Record (BMR) contains manufacturing activities for capsules like-
    • Drying,
    • Mixing,
    • Filling and
  • Inspection process with the provisions of recording time of performing activity and initial of the responsible person.
  • Batch Manufacturing Record (BMR) contains manufacturing activities for liquid syrup like
    • Syrup preparation,
    • Filtration/homogenization,
    • Filling,
    • Sealing,
    • Inspection process, &
  • Packing with the provisions of recording time of performing activity and initial of the responsible person.
  • Batch yield details.

  • Content of the Batch Packaging Records (BPR):

  • Batch Packaging Record (BPR) shall contain the steps of primary packing as stated in the Master Formula records with provisions for recording the time of performing the activity and signature of the responsible person.
  • The format of the Batch packing Record shall be prepared on approved format.
  • The format of Batch Packaging Record (BPR) will be valid as per old format & shall be revised with new format when there is any change.
  • The part of the Batch Packaging Record (BPR) shall have the following details:
    • Cover page shall have the complete details of product under packing operation.
    • Check list
    • Packing material details.
    • Packing operation & instruction
    • Line Clearance Checks
    • In-process record for overprinting of the primary, secondary & tertiary packaging materials
    • In-process record for packing operation of primary, secondary & tertiary packaging materials.
    • C-box weighing records
    • Packaging material reconciliation record
    • Yield calculation
    • Deviation
    • Specimen signature log as per Annexure-V.

Remarks: For existing documents Annexure-V shall be issued till next revision of respective BPR.

• • The master copy of Batch Manufacturing Record (BMR)/BPR shall be printed on A4 size paper, the font style of the text matter shall be “Arial” and the font size shall be “11”.
  • For the tabular representation the font size may be reduced but not less than 10.
  • Page number is assigned to each page of the BMR and BPR.
  • The page number shall be in the form of X of Y; where X stands for the first page and Y stands for the total no. of pages in that particular part of the BMR and BPR.

  • Preparation, checking, and approval of Master Formula Record (MFR)/ Batch Manufacturing Records (BMR)/ Batch Packaging Records (BPR)

  • For MFR:

  • PDL Chemist shall prepare MFR based on the R&D document & forward to Head PDL for checking.
  • QA shall check & send the signed MFR to Head QA for approval.
  • Prior to approval, any points required to be rectified or shall be amended.
  • Signatures with Date & Name of the Prepared by, checked by, approved by & authorized by shall be made on first page of the MFR and remaining preceding pages of MFR only sign & date of Prepared by, checked by and approved.

  • For BMR/BPR:

  • Production Chemist and above shall prepare Batch Manufacturing Record (BMR)/BPR based on the MFR & forward to Head Production / Designee for checking.
  • After checking Officer Production shall do the corrections if any & print the Batch Manufacturing Record (BMR) / BPR and send the signed document to QA for approval.
  • Head QA shall approve the Batch Manufacturing Record (BMR) /BPR.
  • Prior to approval, any points required to be rectified or shall be amended.
  • Signatures with Date & Name of the Prepared by (Production Chemist and above), checked by (Production Executive and above), approved by (Head Production & Head QA) shall be made on BMR/BPR as per annexure-II & III (For EU Products).
  • Whenever any customer signature to be required in the Master BMR/BPR same shall be incorporated under the Approved by column.
  • For scale up batches the master BMR shall be prepared as per the Annexure-IV.
  • PDL shall prepare & check the scale-up BMR and shall be approved by Head QA.

5.0   Reference – Batch Manufacturing Records (BMR) :

• • The Rules Governing Medicinal Products in the European Union : Volume 4,
  • EUGMP Medicinal Products for Human and Veterinary Use. Chapter 4: Documentation
  • Drug and cosmetic Act : Schedule M

6.0   Annexure:

Format for Batch issuance register

Product Name:…………………………………….

Format for Batch Manufacturing Record (BMR)

1. GENERAL INFORMATION’S:

Format for Batch Packing Record (BPR)

1. GENERAL INFORMATION’S:

Signature Log

Product Name:                                                                                            Batch No: