Batch Manufacturing Record (BMR) and BPR
Batch Manufacturing record is controlled document which contains all the detail of Manufacturing Process or individual batch recorded during the Manufacturing of Products.
- 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 person.
- The Batch Manufacturing Record shall be prepared on approved format
- The format of BMR will be valid as per old format & shall be revised with new format when there is any change.
Contents of Batch Manufacturing Record (BMR) (Not Limited)
- The BMR shall have the following details:
- Cover page shall have the complete details of product being manufactured.
- Check list – General Information
- Raw material dispensing & weighing records. (Bill of Material)
- API calculation for quantity of active ingredient (s) according to their assay & LOD/water.
- Line clearance provision.
- Complete stage wise details of product process.
- Yield calculation
- Deviation / Change control.
- Release detail for packing.
- BMR contains manufacturing activities for aerosols like mixing, Filtration 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)
- BPR shall contain the steps of primary packing as stated in the Master Formula Record 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 BPR will be valid as per old format & shall be revised with new format when there is any change.
- The BPR shall have the following details:
- Cover page shall have the complete details of product under packing operation.
- General Information
- Packing material details. (Bill of Material)
- Packing operation & instruction
- Line Clearance Provision.
- In-process record for overprinting of the secondary & tertiary packaging materials
- In-process record for packing operation of primary and secondary packaging materials.
- Final packed box weighing records.
- Packaging material reconciliation record.
- Yield calculation
- Deviation / Change Control
- Batch Release
- The master copy of BMR/BPR shall be printed on A4 size paper, the font style of the text matter shall be as per company policy and the font size shall be “10-12”. 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 Batch Manufacturing Records (BMR)/ Batch Packaging Records (BPR)
For BMR/BPR:
- Executive/Officer production shall prepare BMR/BPR based on the MFR & forward to Head Production / QA for checking.
- After checking Executive/Officer production shall print the BMR and send the signed document for checking to their immediate superior & QA for review and Head Production and Head-QAD 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 shall be made on first page of the BMR/BPR and remaining preceding pages of BMR/BPR only sign & date of Prepared by, checked by and approved by sign.
- Numbering system of Batch Manufacturing Records (BMR)
BMR number shall be assigned as, Company Code/BMR/XYZ/NNN-RR; where,
XYZ : Product Abbreviation
/ : Separator
NNN: Serial number of the BMR as 001,002,003,004 and so on.
- : Dash
RR: Revision number of the BMR
- The master list of BMR shall be maintained in QA department.
Numbering system of Batch Packaging Records (BPR)
BPR number shall be assigned as, Company Code/BPR/XYZ/NNN-RR; where,
BPR : Batch Packing Records
/ : Separator
XYZ : Product Abbreviation
/ : Separator
NNN: Serial number of the BMR as 001,002,003,004 and so on.
-: Dash
RR: Revision number of the BPR
- The master list of BPR shall be maintained in QA department.
- Production Department shall raise duly filled and signed “Requisition for BMR and BPR” and submit to QA.
- QA personnel shall issue the BMR/ BPR to Production
