Bmr and Bpr Review Means in Pharmaceutical Business

 Batch Manufacturing Record (BMR) and BPR

Batch Manufacturing record is controlled document which contains all the detail of Manufacturing Process or private 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 canonical format

• The format of BMR will be valid as per old format & shall be revised with new format when in that location is any change.

Contents of Batch Manufacturing Record (BMR) (Not Express)

• The BMR shall take the following details:
• Comprehend page shall accept the complete details of production being manufactured.
• Bank check listing – General Information
• Raw fabric dispensing & weighing records. (Beak of Material)
• API calculation for quantity of active ingredient (due south) according to their analysis & LOD/water.
• Line clearance provision.
• Complete stage wise details of production process.
• Yield calculation
• Deviation / Change control.
• Release detail for packing.

• BMR contains manufacturing activities for aerosols similar mixing, Filtration with the provisions of recording fourth dimension of performing activeness and initial of the responsible person.
• Batch yield details.
• Content of the Batch Packaging Records (BPR)

• BPR shall incorporate the steps of primary packing as stated in the Main Formula Record with provisions for recording the time of performing the activity and signature of the responsible person.
• The format of the Batch packing Tape shall exist prepared on canonical format
• The format of BPR will be valid every bit per old format & shall be revised with new format when there is whatever change.
• The BPR shall have the following details:
• Embrace page shall take the complete details of product under packing operation.
• Full general Information
• Packing material details. (Beak of Material)
• Packing functioning & instruction
• Line Clearance Provision.
• In-procedure tape for overprinting of the secondary & 3rd packaging materials
• In-procedure record for packing operation of primary and secondary packaging materials.
• Concluding packed box weighing records.
• Packaging material reconciliation tape.
• Yield adding
• Deviation / Change Control
• Batch Release

• The master copy of BMR/BPR shall be printed on A4 size paper, the font mode of the text matter shall be every bit per visitor policy and the font size shall be "x-12". For the tabular representation the font size may be reduced only 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 beginning 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/Officeholder product shall set up BMR/BPR based on the MFR & forward to Head Production / QA for checking.

• After checking Executive/Officer production shall impress 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, whatsoever points required to exist rectified or shall be amended.

• Signatures with Date & Name of the Prepared past, checked by & approved past shall be made on first folio of the BMR/BPR and remaining preceding pages of BMR/BPR only sign & date of Prepared by, checked by and approved by sign.

• Numbering organization of Batch Manufacturing Records (BMR)

BMR number shall be assigned as, Visitor Code/BMR/XYZ/NNN-RR; where,

XYZ : Product Abbreviation

/ : Separator

NNN: Serial number of the BMR equally 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, Visitor Code/BPR/XYZ/NNN-RR; where,

BPR : Batch Packing Records

/ : Separator

XYZ : Production Abridgement

/ : Separator

NNN: Series number of the BMR every bit 001,002,003,004 then on.

-: Nuance

RR: Revision number of the BPR

• The master listing of BPR shall exist 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

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Source: https://www.pharmaqualification.com/2020/09/batch-manufacturing-record-bmr-and-bpr.html

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