MEDIOINT LIFESCIENCE PVT.LTD.

Plot No.260 A, Sector-III Pithampur, Dist. Dhar-454774(M.P)

PRODUCTION DEPARTMENT
STANDARD OPERATING PROCEDURE
SOP No. PRD 036 Effective Date
Revision No. 00 Review Date
Supersedes Nil Page No. 1 of 4
TITLE SOP FOR BMR/BPR MANAGEMENT

1.0 PURPOSE:
This SOP provides the guideline for BMR/BPR management
2.0 SCOPE:
This SOP is applicable to provide the written guidelines for BMR/BPR Management in
Production department at Medioint Lifescience Pvt. Ltd., Pithampur.
3.0 RESPONSIBILITY:
3.1 Production /Officer /Executive /department Head shall be responsible for Management of
BMR/BPR Production department.
3.2 Head of department shall be responsible for checking and compliances of this SOP.
3.3 Accountability: Production Head and QA Head shall be accountable for implementation of
this SOP.
4.0 SAFETY AND PRECAUTIONS:
NA
5.0 ABBREVIATION:
SOP - Standard Operating Procedure
PRD - Production Department
QAD - Quality Assurance Department
AR. No. - Analytical Report Number
Pvt. Ltd. - Private Limited
Qty - Quantity
MFG. - Manufacturing Date
EXP. - Expiry Date
F - Format

Prepared By Reviewed By Approved By Authorized By

Signature
Date
Name
Designation Production Production Production QA
Officer Executive Manager Manager
 MEDIOINT LIFESCIENCE PVT.LTD.
Plot No.260 A, Sector-III Pithampur, Dist. Dhar-454774(M.P)
PRODUCTION DEPARTMENT
STANDARD OPERATING PROCEDURE
SOP No. PRD 036 Effective Date
Revision No. 00 Review Date
Supersedes Nil Page No. 2 of 4
TITLE SOP FOR BMR/BPR MANAGEMENT

6.0 DEFINITION:
NA
7.0 PROCEDURE:
7.1 Recording of BPR:
7.1.1 Check the BPR for product name, batch number, batch size, and manufacturing date, expiry
date, MRP. etc.
7.1.2 Enter the required entries in BPR i.e., packing starting date, time, shift, name of machine &
equipment no. operator name, name/ code of checkers.
7.1.3 Fill the required entries in BPR after specified time as per product specification.
7.1.4 If any wrong entry entered, cut it and enter right entry and put initial there.
7.1.5 Don’t overwrite.
7.1.6 BPR will be recorded online.
7.1.7 BPR should be filled up by Production Office/Executive/Supervisor.
7.2 Reconciliation of BPR:
7.2.1 Count the packed quantity after completion of batch.
7.2.2 Calculate the number of cartons, tubes, labels, insert, shippers, Bopp tape, cello tape etc. used
in the batch based on the quantity packed.
7.2.3 Count the balance quantity of cartons, tubes, labels, insert, shippers, Bopp tape, cello tape etc.
Take the stock of balance & rejected cartons, labels etc. and record in the BPR.
7.2.4 Follow the calculation mentioned in the Batch packing record for reconciliation.
7.2.5 (Quantity used+ Rejection+ Balance leftover) - (quantity issued) = Variance.

Prepared By Reviewed By Approved By Authorized By

Signature
Date
Name
Designation Production Production Production QA
Officer Executive Manager Manager
 MEDIOINT LIFESCIENCE PVT.LTD.
Plot No.260 A, Sector-III Pithampur, Dist. Dhar-454774(M.P)
PRODUCTION DEPARTMENT
STANDARD OPERATING PROCEDURE
SOP No. PRD 036 Effective Date
Revision No. 00 Review Date
Supersedes Nil Page No. 3 of 4
TITLE SOP FOR BMR/BPR MANAGEMENT

7.2.6 Make the entry for extra consumed or returned quantity of packing material in respective
BPR if any.
7.2.7 Return any recovery left after completion of the batch to manufacture and make entry in BPR
and yield book.
7.2.8 After completion of batch/product make entry for in process sample, recoverable (if any),
non-recoverable and other sample in BPR and carry out batch reconciliation Actual B. Size-
[Qty. Packed+ in process sample+ sample to QC+ Recovery(if any)+ Non recoverable]
=Variance
4.3 Recording of Yield:
7.3.1 After the completion of packing operation and before transfer of finished goods to the
warehouse, calculate the quantity of Tube in number as per the batch size being transferred
and calculate the percentage yield at packing stage. Record this percentage yield for packing
in the BPR
7.3.3 Leak Test quantity and sampling quantity shall be mentioned, and cumulative quantity
transferred is calculated.
7.3.4 Packing yield is calculated as total quantity transferred against actual batch size. If any
recovery is there it shall be mentioned in the form of Tube and then final yield shall be
calculated including recoverable and no recoverable rejection.
4.4 Handover of BMR/BPR to QA:

7.4.1 After Completion of steps 4.1, 4.2 and 4.3 handover the BPR to IPQA for review.
7.4.2 All the reviewed points are complied.
7.4.3 Handover the completed BPR to Quality Assurance.
7.4.4 BMR transfer record shall be made in format APBC/PGI/014/F-02.
8.0 FREQUENCY:
Prepared By Reviewed By Approved By Authorized By
Signature
Date
Name
Designation Production Production Production QA
Officer Executive Manager Manager
 MEDIOINT LIFESCIENCE PVT.LTD.
Plot No.260 A, Sector-III Pithampur, Dist. Dhar-454774(M.P)
PRODUCTION DEPARTMENT
STANDARD OPERATING PROCEDURE
SOP No. PRD 036 Effective Date
Revision No. 00 Review Date
Supersedes Nil Page No. 4 of 4
TITLE SOP FOR BMR/BPR MANAGEMENT

NA
9.0 SUPPORTING DOCUMENTS:

Format No. PRD 036/F01 : Format For Yield Register

Format No. PRD 036/F02 : Format For BMR/BPR Transfer Record

Format No. QAD 002/F11 : Format For History Sheet.

10.0 REFERENCES:
In House.

Prepared By Reviewed By Approved By Authorized By

Signature
Date
Name
Designation Production Production Production QA
Officer Executive Manager Manager