Management of Batch Manufacturing Record and  Batch Packing Record SOP

By / Quality Assurance / QA, SOP /

SOP for Preparation of BMR and BPR | Batch manufacturing record in pharmaceutical industry | Batch packing record in pharmaceutical industry

  • BMR / BPR SOP covers below points:
    • General Guideline for Batch Manufacturing & Batch Packing Record
    • BMR Preparation
    • BPR Preparation
    • Contents of BMR/BPR
    • Batch Numbering to BMR/BPR
    • Issuance and Retrieval of BMR/BPR
    • Review of Batch Record
    • Retention of BMR/BPR
    • Tablet/Capsule BMR format
    • Batch Packing Record format
1.0 OBJECTIVE :
  • To describe a procedure for Issuance, Data Entry, Reconciliation, Retrieval, Review and Retention of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR).
2.0 SCOPE :
  • This procedure is applicable for drafting and approval of all BMR and BPR, prepared as hard copy.
3.0 RESPONSIBILITY :
  • Q.A. Chemist and above is responsible for preparing, issuance & retrieval of BMR & BPR.
  • Concerned Head of Department or his/her designee is responsible for timely data entry and review of BMR & BPR and monitor the activity as per guidelines.
  • Quality Assurance Head or his/her designee is overall responsible for execution.
4.0 ACCOUNTABILITY:
  • Quality Assurance Head
5.0 PROCEDURE :

5.1 General Guideline for Batch Manufacturing & Batch Packing Record:

  • Batch Manufacturing Records is product and batch specific document designed to give a complete and reliable picture of the manufacturing history of each batch of every product.
  • Batch Packing Records is product and batch specific document designed to give a complete and reliable picture of the packaging history of each batch of every product.
  • Batch Manufacturing Record (BMR) & Batch Packing Record (BPR) shall essentially be based on the Master Formula Record (MFR) and Master Packing Record (MPR). The document are prepared by Q.A. Chemist and above, checked by Departmental Head (or his Deputy in his/her absence) from Production Department & Approved by Head QA/Plant /Technical.
  • After signing the Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) put Master copy stamp on left side above the header with green colour ink as described in SOP for Documentation.
  • Batch Manufacturing & Batch Packing Record are document to be used on the shop floor and shall thus be designed giving clear, precise information and instructions.
  • Apart from preprinted instruction/directions space is provided to enter variable e.g. date, time, name of person, signature etc.

5.2 Preparation:

  • Master copy of BMR/BPR are made available in A4 size white paper.
  • In few cases where batch size varies, e.g., encapsulation of pellets, the BMR/BPR are prepared as per requirement.
  • Layout of BMR and BPR:
    • Set the page margin in narrow before giving print.
    • All BMR are prepared as per Annexure 1 for (Tablet & capsule), and BPR as Annexure 2 for (Packing).
    • BMR and BPR  should have header except first page and footer on every page.
    • First page consists of information related to Product Details, Batch Particular and Signatories.
    • Content of Product Details for BMR:
      • Product Name, Generic Name, Manufacturing License No, Batch Size, MFR No, BMR, Revision No, Supersedes, Average Weight of Uncoated Tablets or Filled Capsule,  Shelf Life, Reason for Revision, Label Claim.
    • Content of Product Details for BPR:
      • Product Name, Generic Name, Manufacturing License No, Batch Size, MFR No, BPR No, Revision No, Supersedes, Pack Style, Average Weight of Uncoated Tablets or Filled Capsule  Shelf Life, Reason for Revision, Label Claim.
    • Content of Batch Particular for BMR and BPR:
      • Batch No, Mfg Date, Exp Date.
    • Content of Signatories for BMR and BPR:
      • Signature, Date, Name, Designation of who sign with name and date Prepared by, Checked by, Approved by.
    • Header of BMR and BPR:
      • In header of BMR and BPR draw table having three rows and three columns.
      • Put Logo of the company on left hand side above the header of the BMR or BPR.
    • Footer of BMR and BPR:
      • Footer of BMR and BPR contain Page No in centre with total number of pages, Format No. on the right hand side.
    • Other content will have font of “Arial Rounded MT Bold’’ with size 10.
  • Content of BMR and BPR:
    • Name:
      • Put “BATCH MANUFACTURING RECORD” OR “BATCH PACKING RECORD”  in the first row.
    • Product Name:
      • Put “PRODUCT NAME ” in Capital in left side of second row.
    • Generic Name:
      • Put “GENERIC NAME ” in Capital in left side of third row.
    • Batch Number:
      • Keep this space blank to put batch number manually on the right side of second column. The data will be entered by QA chemist and above at the time of issues.
    • Batch Size:
      • Put “BATCH SIZE” in Capital in right side of second column.
    • Checked By:
      • Put “Checked By QA Department” in right side of three column.

5.3 Batch Manufacturing & Batch Packing Records include:

  • BMR/BPR provides stepwise instructions for carrying out activities with limits. Also the completed BMR/BPR must have information as;
    • Detail about the Product
    • Manufacturing license and Label claim
    • Attachment in BMR/BPR
    • Cleaning status, detail of previous product, sieve integrity during sifting.
    • Which equipments are used in batch manufacturing and packaging
    • Record showing the identification and status of equipment / area used for activity.
    • Who has checked / supervised / verified the operation ?
    • Endorsement by Expert staff under whose supervision the activities was performed.
    • Who has performed the operation ?
    • When the operation was performed ?
    • Details of manufacturing controls, in-process checks, approval etc.
    • Actual environmental conditions observed at the time of processing.
    • Theoretical and practical yield at different stages during processing.
    • Reference to MFR/MPR
    • Limit for every critical parameter that is required to be performed.
    • Any special precaution to be exercised.
    • Temperature and humidity of intermediate products during storage.
    • Reconciliation of packaging materials received, utilized, rejected destroyed and returned / delivered to Warehouse Department.
    • Batch approval (actual quality) before sale / supply .

5.4 Data Entry:

  • In order to enter the observations, variables space is provided at appropriate places.
  • All entries are made correctly and promptly by the person (s) performing the task(s) using indelible ink. Ink colour is described in SOP for Documentation.

5.5 Give Batch Numbering to BMR/BPR in the following manner,

  • Batch Manufacturing Record :
    • Tablet section    –    BMR/TAB/001-01, BMR/TAB/002-01, BMR/TAB/003-01…
    • Capsule section –   BMR/CAP/001-01, BMR/CAP/002-01, BMR/CAP/003-01…
  • Batch Packing Record :
    • Tablet section    –    BPR/TAB/001-01, BPR/TAB/002-01, BPR/TAB/003-01…
    • Capsule section –   BPR/CAP/001-01, BPR/CAP/002-01, BPR/CAP/003-01…
  • Where,
    • BMR:  Batch Manufacturing Record, BPR: Batch Packing Record, TAB: Tablets, CAP: Capsules, 001: Serial number of documents, 01: Revision number of document.

5.6 Issuance and Retrieval :

  • MASTER COPY of BMR / BPR of all products is kept in Quality Assurance Department in safe custody under lock & key. Access of the same is restricted.
  • Issue BMR and BPR after receiving a filled requisition from Production Department.
  • Make photocopy of master BMR and BPR and stamp it with ‘CONTROLLED COPY’ in violet ink at the right side of bottom of the each page.
  • In case of Process validation batches put ‘VALIDATION BATCH’ stamp on BMR by using rubber stamp in violet ink at left bottom of the front page of BMR and put ‘STABILITY BATCH’ rubber stamp in violet ink at left bottom of the front page of BPR.
  • Controlled copy of BMR/BPR document is issued by QA Chemist or above for particular batch.
  • Make entry of issuance in ‘BMR/ BPR Control Register’ and take receivers signature into register. The issued BMR/BPR are received by Production chemist/Supervisor and above only.
  • Make necessary online entries in BMR/ BPR by respective person and follow the procedure given in BMR and BPR.
  • Attach other necessary documents along with BMR/BPR, on completion of manufacturing and packing activities.
  • Respective department must submit the completed BMR/BPR, once the activity is over and reconciliation is done.
  • After receiving filled BMR and BPR from Production Department, put retrieval date on ‘BMR/ BPR Control Register’.

5.7 Review of Batch Record:

  • Guidelines:
    • The batch records are reviewed for compliance with approved specifications, written manufacturing directions and required documentation as per GXPs. The review of batch record can conveniently be carried out by making a checklist of the items which require verification. Quality Assurance Department verifies each items listed in the checklist (attached as a part of batch record) for completeness. It should, however, be noted that batch record review is not meant as a sole procedure for the approval of the product. It is essential that as the batch of product progresses through various stages of manufacturing, the related manufacturing, and control documents are checked and approved by authorized persons prior to submission to Q.A. Department for final batch record review.
    • List Of Records To Be Checked:
      • Dispensing Record
      • Manufacturing record
      • In process controls
      • Packaging record
      • Analytical test reports
      • Specimens
      • Presence of all the pages in the Batch Record 
      • All the necessary attachments
      • Batch Number, Manufacturing Date (mfg. dt.), Expiry Date (exp. dt.) and Shelf Life of the batch
      • For all the necessary entries made in the space provided and none of the space kept blank
      • Line clearances are taken at the required stages and recorded for the Name of Previous Product, Batch Number of Previous Product, Cleanliness status
      • For Swab/Rinse Sample Testing Report attached, wherever applicable
      • Raw Material/ Packaging Material Dispensing Slip and Raw Material/ Packaging Material Requisition record for the Material Name, Analytical Report (AR) Number, Product Name, Batch Number, Batch Size, Lot Number, mfg. date, exp. date, Dispensed Quantity and all the necessary signatures  
      • Yield of product at various stages of manufacturing and packing is within limits as per standards provided and reconciliation done
      • Intimation slips for sampling at various stages of manufacturing and packing and the Quality Control reports attached
      • In process records written by Production and Q.A. Departments for completeness and compliance with the standards
      • Specimen samples attachment for Product name and other necessary printing/ embossing details
      • Packaging material reconciliation for the correctness of the entries
      • Investigation record of extra raw/packaging material, if any
      • Attachment of the Finished Product Approval Slip, Material Transfer Note etc. to the batch records
      • Mention the details of deviation report, if any
      • Get batch records checked by Q.A. Officer and forward it to Quality Head or his/her Deputy for the approval of product.
      • Transfer the batch from Packing Department to (Finished Good) Warehouse, by generating ‘Material Transfer Note’.

5.8  Retention of BMR and BPR:

  • Retain all batch related records like BMR and BPR up to the one year after the expiry of the product. Keep Validation BMR and BPR for 10 years.
  • Maintain all BMR, BPR into labeled corrugated boxes duly arranged in racks as per manufacturing date of the product, in the room provided. The locked room is in the custody of Q.A. Head. 
  • BMR and BPR are destroyed after this validity period as per destruction procedure, SOP for Documentation.
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
SOPStandard Operating Procedure
Q.A.Quality Assurance
BMRBatch Manufacturing Record
BPRBatch Packing Record
GXPIncludes all good practices in pharmaceutical activity e.g., Good Engineering Practices, Good Warehouse Practices etc.
MFRMaster Formula Record
MPRMaster Packing Record
BMRBatch Manufacturing Record

7.0 ANNEXURES:
Annexure No.Title
01Format for Batch Manufacturing Record (Tablets & Capsules)
02Format for Batch Packing Record

8.0 SOP REFERENCES
  •  GXP Guidelines

END OF THE SOP

ANNEXURES :

Annex. No. 01 Format for Batch Manufacturing Record (Tablets & Capsules)

Annex. No. 02 Format for Batch Packing Record