- OBJECTIVE:
To lay down a Procedure for Preparation of Batch Manufacturing and Batch Packing Records.
- SCOPE:
This SOP is applicable for Preparation, Review; Approval of Batch Manufacturing and Batch Packing Records. This SOP also describes the Control, Issuance, Revision, Retrieval and Destruction of Batch Manufacturing and Batch Packing Records at {Company Name} {Company Location}.
- RESPONSIBILITY:
IPQA and production officer/ Executive shall follow the instruction as per given procedure.
IPQA and production officer/ Executive are responsible to check and record the in process check in Batch Manufacturing and Batch Packing Records.
Production Head / Manager shall be responsible for the review of Batch Manufacturing and Batch Packing Records.
QA Executive / Designee shall be responsible for control, issuance, Revision, retrieval & Destruction of Batch Manufacturing and Batch Packing Records.
- ACCOUNTABILITY:
Head QA and Production Head shall be accountable for implementation of this SOP.
- PROCEDURE:
PREPARATION OF A NEW BATCH MANUFACTURING AND BATCH PACKING RECORDS (BMR/BPR)
For preparation of BMR/BPR, initiators shall follow following Guidelines / Instructions
The BMR/BPR shall be written in English Language by using Microsoft Word typing.
Batch Manufacturing and Batch Packing Record shall be prepared separately.
Production (Officer / Executive) shall prepare the BMR and BPR as per reference Master Formula Card (MFC) / Executed Batch Record (For Site Transfer, if MFC/MPC not available), Standard Packing Card (SPC) and Master Packing Card (MPC).
Production Head / officer / executive shall check the completeness of draft BMR/BPR and send the draft copy of BMR and BPR to QA Head or his designee for review against the reference MFC/MPC/Executed Batch Record.
The reviewer shall check the draft BMR/BPR for accuracy of the subject matter and shall return the same to originating Department.
After receiving the comments (if any) from QA head or his designee, Production officer/executive incorporate the comments (if any) in the BMR/BPR and send the final copy to QA head or his designee for final review and signature.
A number to the BMR shall be assigned as:
BMR: – BMR/XXX
Where,
BMR – Batch Manufacturing Record
‘/’ – Slash
XXX- Indicate the Numbering System
For Example: – BMR/001; BMR/002 and so on.
- A number to the BPR shall be assigned as:
BPR: – BPR/XXX
Where,
BPR – Batch Packing Record
‘/’ – Slash
XXX – indicates the Numbering system
For example: – BPR/001; BMR/002 and so on.
A Supersede number to the BMR & BPR shall be assigned as:
BMR: – BMR/XXX-NN
BPR: – BPR/XXX-NN
Where,
BMR- Batch manufacturing record
BPR- Batch Packing Record
‘/’ – Slash
XXX – Indicates the Numbering Systems
‘-’ – Hyphen
NN- Indicates the Previous version number
For example: – In BMR – BMR/001-00, BMR/001-01 and so on.
In BPR- BPR/001-00, BPR/001-01 and so on.
If BMR/BPR are newly prepared the supersede number will be Nil.
- BMR and BPR shall be prepared with generic name.
- No manual correction shall be made in Approved Copy (Master / Controlled Copy).
- Master BMR & BPR shall be maintained by QA officer/executive.
- LAYOUT OF BMR/BPR:
BMR/BPR Format Considerations:
All BMR/BPR shall contain Header Part, Body Part and Footer Part. “BMR/BPR Format” shown in
Annexure-I.
- All pages shall contain Format No. in Footer part.
- All the points in the BMR/BPR shall be numbered sequentially.
- Maintain the proper space between the Rows of the tables for filling the details.
- Font size of table Content may be Changeable in case of insufficient space but it should be not less than 9 Font.
- All BMR/BPR contents shall be covered by Single Borderline with ½ Line Weight (Width).
- BMR/BPR Header shall be covered by a borderline with 3 Line Weight (Width), Specimen of Header of BMR/BPR shown in Annexure-I.
- Line Spacing and Font Size: The Line Spacing between two points or title & subtitle shall be Single / 1.5 lines font style shall be Times New Roman 12 font. Font size may be less in case of Table and Remarks.
- BMR/BPR (Master Copy) shall be printed on A4 size Off-white colored Executive Bond Paper using “Times New Roman” Font with Black Ink. Printing shall be done on one side of the paper only.
- Paper Selection for Print: Paper 8.5” (Width), 11.69” / 11.5” (Height), Border Top 24pt, Left 24pt, Right 24pt and Bottom 31pt with A4 Size Scaling.
- CONTENT OF HEADER PART OF BMR:
- Header:
The Header of BMR shall include the Name of Organization (Including Name of Location).Header shall have the Logo of Organization in Left corner on Top, and followed by Title – “Batch Manufacturing Record” in center as shown in Annexure-I.
The header of BMR has generic name of the product, BMR No., Effective date, Rev. No., Supersedes No., Mfg. date, Exp. Date, Batch No. and Page No.
- Generic Name: It contains the generic name of the product for which the BMR has been prepared.
- Batch Size (in kg or in number): It is the total batch size of product in kilogram or in the number of unit.
- BMR No.: It is the reference number assigned to BMR as mentioned in step 5.1.7.
- Batch Number: It is the batch No. of product for which the BMR has been issued and to be written manually or with stamping at the time of issuance of BMR.
- Revision No.: It is the current revision No. of BMR.
- Supersedes No.: It is the previous revision No. of BMR.
- Effective Date: This is the date on which the BMR comes into effect.
- Date: This is the month in which product has to be manufactured. It shall be assigned as per internal policy of company.
- Date: Based on the shelf life of product expiry shall be mentioned at the time of issuance of BMR / BPR.
- Page No.: It has total No. of pages in BMR. It shall be written in X of Y format. Where Y is total No. of pages and X is current page. For Example: If a BMR/BPR contains 60 pages then the first page of the BMR/BPR shall be Start from 1 of 60, 2 of 60 …………and shall be pre-printed
- CONTENT OF THE BODY OF BMR:
First Page of BMR: The first page of BMR has following information
- Composition: It has name and strength of active ingredient.
- Dosage Form: It has dosage form of product i.e. tablet, capsule, liquid or injection.
- Shelf Life. It shall be assigned by reference of respective MFR/MFC/Executed Batch Record of the product.
- Manufacturing License No.: It is the license No. for the product assigned by drug controller.
- Reason for revision: Reason for revision of the BMR shall be recorded and details of all revision maintained in the “Revision History of BMR/BPR” as per Annexure-II.
- Batch commenced on and batch completed on: These are date for commencing and completion of the batch.
- Unexecuted BMR issued by: QA officer/executive shall put the sign along with date in this column at the time of issuing unexecuted
- Unexecuted BMR received by: Production officer/executive put the sign along with date in this column at the time of receiving the unexecuted
- Last Page of BMR/BPR: Revision History column shall put the end page of BMR/BPR.
- CONTENT OF FOOTER PART OF BMR:
It contains the format No. in all pages, Name of Prepared by, Reviewed by, approved by along with, Sign, Date and Name in front page of BMR.
- CONTENT OF HEADER PART OF BPR:
- Header: The Header of BPR shall include the Name of Organization (Including Name of Location). Header shall have the Logo of Organization in Left corner on Top, and followed by Title – “Batch Packing Record” in center as shown in Annexure-I
The header of BPR has generic name of the product, BPR No., Rev. No., Supersedes No., Batch No., Effective date, Mfg. date, Exp. Date and Page No.
- Generic Name: It contains the generic name of the product for which the BPR has been prepared.
- BPR No.: It is the reference number assigned to BPR as mentioned in step 5.1.8
- Batch Number: It is the batch No. of product for which the BPR has been issued and to be written manually or with stamping at the time of issuance of BPR.
- Manufacturing Date: This is the month in which product has to be manufactured.
- Expiry Date: Based on the shelf life of product month of expiry shall be assigned by QA officer/executive.
- Batch Size: It is the standard batch size of the product as per requirement.
- Revision No.: It is the current revision No. of BPR.
- Effective Date: This is the date on which the BPR comes into effect.
- Page No.: It has total No. of pages in BPR. It shall be written in X of Y format, where Y is total No. of pages and X is current page. For Example: If a BMR/BPR contains 60 pages then the first page of the BMR/BPR shall be Start from 1 of 60, 2 of 60 …………and shall be pre-printed.
- CONTENT OF THE BODY OF BPR:
The first page of BPR has following information.
- Composition/Label Claim: It has name and strength of active ingredient.
- Dosage Form: It has dosage form of product i.e. tablet, capsule, liquid or injection.
- Manufacturing License No.: It is the license No. of the product assigned by drug controller.
- Shelf Life. It is assigned by the reference of respective MFR/MPC/Executed Batch record of the product.
- Mother/Manufacturing Batch No.: It is the batch number mentioned on the respective BMR in which against the product is being pack.
- Batch Size: It is the standard batch size of the product as per requirement.
- Reason for revision: Reason for revision of the BPR shall be recorded and details of all revision maintained in the “Revision History of BMR/BPR” as per Annexure-II.
- Unfilled BPR Issued by: QA officer/ executive shall put the sign along with date in this column at the time of issuing unfilled
- Unfilled BPR Received by: Production officer/executive put the sign along with date in this column at the time of receiving the unfilled BPR
- CONTENT OF FOOTER PART OF BPR:
It contains the format No. in all pages of BPR, Prepared by, reviewed by and approved by along with Sign, Date and Name in front page of BPR.
- Second Page of BMR / BPR: Second Page of BMR/BPR shall contain “TABLE OF INDEX” in the form of given table. Header Raw of Table shall have gray 25 % Shading Colour.
| S. No. | Title | Page No. |
| – | – |
– |
- Other than First & Second Page:
Content of BMR/BPR to be implemented as per Annexure-III
- GENERATION OF MASTER COPY:
- New BMR/BPR shall be effective within seven days after training if number of days exceeds from seven days then retraining shall be performed and BMR/BPR shall be effective within next seven days
and stamped as “MASTER COPY” in Red ink in square space provided in header (on all the pages) and retain as “MASTER COPY”. Do not use Gel / Fountain Pen for Signing and Filling the documents.
- ISSUANCE, CONTROL AND RETRIEVAL OF BMR/BPR:
- Production Department shall give request for issuing BMR/BPR to QA Department in “BMR/BPR Requisition Form” as shown in Annexure-IV.
- On receipt of requisition slip, QA officer/executive shall take required number of photocopies of the respective BMR & BPR from master copy.
- QA officer/executive shall assign the subsequent batch number for each of this BMR and BPR.
- Compiled BMR/BPR shall be checked by QA before issuing and verified by production at the time of BMR/BPR receiving.
- QA officer/executive shall put stamp as “CONTROLLED COPY” stamp in green ink in right upper corner on all pages and shall issue the BMR & BPR with signature on issued by column on first page.
- On the first page, QA officer/executive writes the following details: Batch No., Mfg. Date & Expiry Date and Batch size.
- The details of issued BMR and BPR shall be recorded in the BMR/BPR issuance record as per Annexure-V and the signatures of receiving production officer/executive shall be taken as receipt of the same.
- If in any case additional copy or pages are required, production officer/executive raise a requisition for the same and mention the reasons for the requirement of additional pages.
- Print Additional Page only after approval by QA Head after receiving the Request form for Additional Page.
- If any issued BMR/BPR not taken in dispensing until the end of the respective month due to any reason or planning change, the issued BMR/BPR shall be return to QA department with proper justification as per Annexure-VI.
- QA head verify the justification and approved/not approved requisition of discard the BMR/BPR.
- After approval of QA head, QA officer/executive shall discard the BMR/BPR and put the remark on BMR/BPR issuance register and issue the next batch No. whenever require.
- A Master List of BMR/BPR shall be maintained by QA Department as per Annexure-VII.
- After completion of Batch, BMR/BPR shall be submitted by the Production Officer / Executive to QA Department. QA shall maintain the record as per format shown in Annexure-V.
- Cover File:
- BMR/BPR Cover file Printing Matter shall be as per format shown in Annexure-VIII.
- Validation Batches Cover file details shall be written manually.
- Colour Codes for Cover File:
- BMR : Yellow Colour
- BPR : Yellow Colour
- Validation Batches : Yellow Colour
Note: Printing on Cover File shall be done by Black Ink on Yellow A4 paper only.
- REVISION OF BMR/BPR:
- BMR/BPR to be revised every two years or as when required as per necessity.
- If there is any change in the MFC, then the R&D informs to the QA/Production. Based on the revised MFC, Batch Manufacturing Record shall be revised.
- If there is any change in the Standard Packing Card or MPC, then the Packaging Development informs to the QA/Production. Based on the revised Standard Packing Card or MPC, Batch Packing Record shall be revised.
- Revision History column shall put in the last past of BMR/BPR.
- After Approval of Change Control QA Officer / Executive shall incorporate the changes in Soft Copy. The Head QA shall approve the revised BMR/BPR in hard copy.
- Old revision shall be made obsolete by stamping with “OBSOLETE COPY”
- New Revised BMR/BPR shall be treated as “MASTER COPY”.
- DESTRUCTION OF BMR/BPR:
- QA Officer / Executive shall destroy the BMR/BPR after one year from the Date of Expiry of Product.
- QA Officer / Executive shall prepare a list of Batch Records, which are due for Destruction as per Annexure-IX for every three months.
- QA Officer / Executive shall destroy the BMR/BPR as per company internal SOP.
- REFERENCES:
- A WHO Guide to Good Manufacturing Practice (GMP) Requirements, Part–I, Standard Operating Procedures and Master Formulae, WHO/VSQ/97.01
- ANNEXURES:
| ANNEXURE No. | ANNEXURE TITLE | FORMAT No. |
| Annexure-I | BMR/BPR Format | QA-005/F01-00 |
| Annexure-II | Revision history of BMR/BPR | QA-005/F02-00 |
| Annexure-III | Content of BMR/BPR to be implemented | QA-005/F03-00 |
| Annexure-IV | BMR/BPR Requisition Form | QA-005/F04-00 |
| Annexure-V | BMR/BPR Issuance and Retrieval Record | QA-005/F07-00 |
| Annexure-VI | Requisition of discard the BMR/BPR | QA-005/F06-00 |
| Annexure-VII | Master BMR / BPR Index | QA-005/F07-00 |
| Annexure-VIII | Cover File Format | QA-005/F08-00 |
| Annexure-IX | Periodic Review of filled BMR/BPR Record for Destruction | QA-005/F09-00 |
| Annexures-X | BMR and BPR Numbering system | QA-005/F10-00 |
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Control copy No. 1 : Head Quality Assurance
- Control copy No. 2 : Head Production
- Control copy No. 3 : Head Warehouse
- Master Copy : Quality Assurance
- ABBREVIATIONS:
| SOP | : | Standard Operating Procedure |
| No. | : | Number |
| Ltd. | : | Limited |
| QA | : | Quality Assurance |
| BMR | : | Batch Manufacturing Record |
| BPR | : | Batch Packing Record |
| S. No. | : | Serial Number |
| IT | : | Information Technology |
| MFR No. | : | Master Formula Record Number |
| Mfg. Date | : | Manufacturing Date |
| Exp. Date | : | Expiry Date |
| MRP | : | Maximum Retail Price |
| ID No. | : | Identification Number |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Enter Manual |
ANNEXURE –I
(BMR FORMAT)
HEADER OF THE FIRST PAGE):
| {COMPANY NAME}{ COMPANY LOCATION}
BATCH MANUFACTURING RECORD |
|||||
| Generic Name : | |||||
| Batch No.: | BMR Revision No.: | Mfg. Date: | |||
| BMR No.: | BMR Supersedes No.: | Exp. Date: | |||
| Effective Date: | Page No.: | Batch Size: | |||
GENERAL INFORMATION
| Product name | : | ||
| Composition | : | ||
| Shelf Life | : | ||
| Mfg. License Number | : | ______ Months from the date of manufacturing. | |
| Date of Commencement | : | ||
| Date of completion | : | ||
| (Quality Assurance Department ) | (Production Department) | ||
| BPR issued by……………………..Date: ……………………………….. | BPR received by…………………………….Date: …………………………………………….. | ||
(FOOTER OF THE BMR)
| Prepared ByProduction Department | Reviewed ByProduction Head | Approved ByQA Head | |
| Sign | |||
| Date | |||
| Name |
| {COMPANY NAME}{COMPANY LOCATION}
BATCH MANUFACTURING RECORD |
| Generic Name: | |||
| Batch No.: | BMR Revision No.: | ||
| BMR Supersedes No.: | |||
| BMR No.: | Page No.: | ||
CHECK LIST
This BMR includes following.
| S. No. | TITLE | PAGE No. | ATTACHED(YES/NO) | |
| PRODUCTION | QUALITY ASSURANCE | |||
FORMAT NO.: QA-005/F01-00
ANNEXURE –I
(BPR FORMAT)
(HEADER OF THE FIRST PAGE):
| {COMPANY NAME}{COMPANY LOCATION}
BATCH PACKING RECORD |
| Generic Name : | ||||
| Batch No.: | BPR Revision No.: | Mfg. Date: | ||
| BPR No.: | BPR Supersedes No.: | Exp. Date: | ||
| Effective Date: | Page No.: | Batch size: | ||
| Product Name | : | ||
| Composition | : | ||
| Dosage Form | : | ||
| Shelf Life | : | _____ Months from the date of manufacturing. | |
| Mfg. License Number | : | ||
| Mother Batch No./Mfg. B. No. | : | ||
| (Quality Assurance Department ) | (Production Department) | ||
| BPR ISSUED BY……………………..
DATE: ……………………………….. |
BPR RECEIVED BY…………………………….
DATE: ……………………………………………..
|
||
(FOOTER OF THE BPR):
| Prepared ByProduction Department | Reviewed ByProduction Head | Approved ByQA Head | |
| Sign | |||
| Date | |||
| Name |
| {COMPANY NAME}{COMPANY LOCATION}
BATCH PACKING RECORD |
||||
| Generic Name: | ||||
| Batch No.: | ||||
| BPR Revision No.: | ||||
| BPR Supersedes No.: | Page No. | |||
CHECK LIST
This BPR includes following.
| S. No. | TITLE | PAGE No. | ATTACHED(YES/NO) | |
| PRODUCTION | QUALITY ASSURANCE | |||
FORMAT NO.: QA-005/F01-00 Page No. X of Y
ANNEXURE –II
| {COMPANY NAME} {COMPANY LOCATION}
QUALITY ASSURANCE DEPARTMENT |
||||
| REVISION HISTORY OF BMR/BPR | ||||
| Effective Date: | Review Before: | |||
PRODUCT NAME |
||||||
| REV.NO. | EFFECTIVE DATE | EFFECTIVE BATCH NO. | REASON FOR REVISIONAND CHANGE CONTROL NO. | SIGN QA | REMARKS* | |
*Also mention Sale, Physician Sample.
FORMAT NO.: QA-005/F02-00 Page No. X of Y
ANNEXURE –III
| COMPANY NAME} {COMPANY LOCATION}
QUALITY ASSURANCE DEPARTMENT |
||
| CONTENT OF BMR/BPR TO BE IMPLEMENTED | ||
| Change Control No. : | ||
Main Contents of the BMR/BPR:
- Line clearance checklist at all the stages of Manufacturing and Packing Operations.
- Always provide the separate space for the affixing of verified samples and status labels.
- Quantitative Formula (Bill of Material)
- API Calculations
- Pre Dispensing / Manufacturing & Packing Instructions.
- Dispensing of Raw / Packing Materials.
- Verification of Dispensed Materials (On Production Floor).
- List of Equipments / Machines to be used for Manufacturing / Packing Process with Machine / Equipment ID No.
- Manufacturing / Packing Processing Details with proper instructions (Separately).
- Stereo Issuance, Retrieval and Destruction Record (in BPR).
- Overprinting Details.
- Stage wise Yield Reconciliation.
- In-process checks during Manufacturing / Packing.
- Environmental Monitoring details at the time of Manufacturing / Packing Process.
- Reconciliation for carton and shipper label to be added.
- Calculation of weight limits of packed carton and shipper to be added.
- Procedure for recording for details of deviation to be added.
- Cumulative reconciliation for the batch to be added.
- Technical person in manufacturing/packing of the batch to be added
- Additional pages check list to be added.
Prepared by Checked by
Sign & Date: Sign & Date:
RMAT NO.: QA-005/F03-00 Page No. X of Y
ANNEXURE –IV
| {COMPANY NAME} {COMPANY LOCATION}
QUALITY ASSURANCE DEPARTMENT |
|
| BMR/BPR REQUISITION FORM | |
Date:
To – QA Department
From – Production Department
—————————————
Kindly issue us BMR/BPR for the following Products.
| S. No. | Product Name |
Batch No. |
Batch Size | Mfg. Date | Exp. Date | Market | Remarks | |
| Sale | PS | |||||||
Request Prepared By: Approved By:
Sign: Production Manager
Date & Time:
FOR QA USE ONLY
BMR/BPR Requisition Received By: Sign/Date:
BMR/BPR Issued By: Sign/Date:
Received By (Production Officer / Executive) Sign/Date:
FORMAT NO.: QA-005/F04-00 Page No. X of Y
ANNEXURE –V
| {COMPANY NAME}{COMPANY LOCATION}
QUALITY ASSURANCE DEPARTMENT |
|
| BMR/BPR ISSUANCE AND RETRIEVAL RECORD | |
| Batch Details | BMR/BPR Issuance | BMR/BPR Retrieval | Remarks | |||||||||||
| S. No. | Product Name | Batch No. | Mfg. Date | Exp. Date | Batch Size | Issued By QA | Received ByProduction | Retrieved ByProduction | Received By QA | |||||
| Sign | Date | Sign | Date | Sign | Date | Sign | Date | |||||||
FORMAT NO.: QA-005/F05-00 Page No. X of Y
ANNEXURE–VI
| {COMPANY NAME}{COMPANY LOCATION}
QUALITY ASSURANCE DEPARTMENT |
|||
| REQUISITION FOR DISCARD THE BMR/BPR | Space For Master Copy Stamp | ||
| Effective Date: | |||
| Review Before: | |||
| Product Name : | Date: | ||
| Batch No: | Date of Issue of BMR/BPR: | ||
| Reason for Discard:Signature:
Date: |
|||
| Comments of Dept. Head:Signature:
Date: |
|||
| Approval Of QA Head: Request Approved/Not ApprovedSignature:
Date: |
|||
| Discard Done By:Date: | Checked By (QA):Date: | ||
FORMAT NO.: QA-005/F06-00 Page No. X of Y
ANNEXURE–VII
| {COMPANY NAME}{COMPANY LOCATION}
QUALITY ASSURANCE DEPARTMENT |
||
| MASTER BMR / BPR INDEX | Space For Master Copy Stamp | |
| Dosage Form: | ||
| Effective Date: | ||
| Revision No.: | ||
| S. No. | Product Name | Product Code | BMR/BPR No. | MFR No. | Effective Date | Revision No. | Remarks |
| Prepared ByQA Officer/Designee | Reviewed ByQA Executive/Designee | Approved ByHead QA/Designee | |
| Sign | |||
| Date | |||
| Name |
FORMAT NO.: QA-005/F07-00 Page No. X of Y
ANNEXURE –VIII
BMR/BPR COVER PAGE FORMAT
|
|||
{COMPANY LOCATION}
BATCH MANUFACTURING/PACKING RECORD
PRODUCT NAME : ………………………………………………………..
BATCH NO. : ………………………………………………………..
MFG. DATE : …………………………………………………………….
EXP. DATE : ………………………………………………………..
BATCH SIZE : …………………………………………………………….
MARKET : …………………………………………………………….
FORMAT NO.: QA-005/F08-00
ANNEXURE –IX
| {COMPANY NAME}{COMPANY LOCATION}
QUALITY ASSURANCE DEPARTMENT |
|
| PERIODDIC REVIEWOF FILLED BMR/BPR RECORD FOR DESTRUCTION | |
Month / Year:
| S. No. | Product Name | Batch No. | Mfg. Date | Exp. Date | Destruction Due On | Remarks |
Prepared By Approved By
QA Officer / Executive QA Head
Sign & Date Sign & Date
FORMAT NO.: QA-005/F09-00 Page No. X of Y
ANNEXURE –X
| {COMPANY NAME}{COMPANY LOCATION}
QUALITY ASSURANCE DEPARTMENT |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
BMR AND BPR NUMBERING SYSTEM
|
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FORMAT NO. QA-005/F10-00 Page No. X of Y
