Preparation and Control of Master Batch Production and Control record

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Preparation and Control of Master Batch Production and Control record

1.0 Objective
To lay down a procedure for preparation and control of Master Batch Production and Control Record.
2.0 Scope
This Standard Operating Procedure is applicable for preparation of Master Batch Production

and Control Record of all block to be followed at formulation plant of abc Pvt. Ltd.
3.0 Responsibility
3.1 Formulation Development department shall be responsible for preparation of Master

Formula Record (MFR) of new product.
3.2 Officer / Executive QA shall be responsible for preparation of BPCR from MFR

based on batch size of product and capacity of equipment.
3.3 Production department shall be responsible for giving batch size and checking of BPCR.
3.4 Head Quality assurance or his/ her designee shall be responsible for compliance of SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
BPCR : Batch Production and Control Record. It contains BMR & BPR
MFR : Master Formula Record
No. : Number
BMR : Batch Manufacturing Record
BPR : Batch Packing Record
R & D : Research & Development

5.0 Procedure
5.1 Research & development department shall prepare Master Formula Record for all

new products. R&D shall send the MFR & Packing specification to plant QA department for preparation of documents.
5.2 QA Officer / Executive shall review the MFR and if any discrepancy found, then

same shall intimate to R& D for correction.
5.3 After receiving MFR & Packing specification, one copy of MFR & Packing specification

shall send to production department for checking the materials and equipment availability.

Based on MFR & Packing specification, production shall recommend the batch size of product

based on equipment capacity and market requirement. If required two batch size of same product

shall recommend by production based on minimum and maximum capacity of equipment.
5.4 QA Officer / Executive shall prepare the BPCR of batch size given by production as per Annexure-1.

Information required as per annexure shall be given by QA.
5.5 BPCR shall divide into two parts, Batch Manufacturing Record (BMR) and Batch Packing Record (BPR).
5.6 QA Officer / Executive shall give the BPCR No. to each product.

BPCR numbering system shall be differentiated according to blocks.
5.6.1 For Tablets & Capsule, numbering system shall be TAC or LIQ or LOZ or DPI/ XXX/YY where,
TAC stands for Tablet and Capsule
LIQ stands for Liquid
LOZ stands for Lozenges
DPI stands for Dry Powder Injection
XXX stands for serial no. of BPCR like 001,002,003
YY stands for revision no. of BPCR like 00 in case of no revision, 01 in case of first revision.
5.6.2 QA Officer/Executive shall give the product code to each product; same code shall be reflected in BPCR.
5.6.3 MFR No. shall be the number of MF received from & D.
5.6.4 Effective date shall be the date from which BPCR can be issued for commercial batch.

Effective date shall be given by QA Officer/ Executive after authorization by Head QA.
5.6.5 Form No. of BPCR shall be given on footer of each page of BPCR.
5.7 BPCR shall contain the all information provided by R & D in MFR for respective product.
5.8 Raw material and packing material dispensing sheet shall be given in two copies, one

copy for BPCR and second copy for warehouse.
5.9 Front page of BMR and BPR shall be signed by the following person for authorization of BPCR.
Prepared By: – QA Officer / Executive
Checked By: – Production Manager
Approved By: – Plant Head
Authorized By: – QA Head
5.10 Draft BPCR shall be circulated to production department for any comment if any.
5.11 After receiving comments from production on draft BPCR, QA Officer / Executive

shall make correction in BPCR and finalized the BPCR for printing.
5.12 After authorization of BPCR, QA Officer / Executive shall stamp as “MASTER COPY” on

non text matter on each page along with sign and date. Date shall be the effective date of BPCR.
5.13 Whenever any change control raised for revision for BPCR, then after approval of

change control by QA Head, QA Officer / Executive shall revised the BPCR.
5.13.1 During revision of BPCR, QA Officer /Executive shall change the BPCR No. as per

revision no. and matter needs to be change as per change control.
5.13.2 QA Officer / Executive shall also maintain the change history log of master documents.
5.14 After approval of revised BPCR, old version BPCR shall stamp as “Obsolete” with
the sign and date of QA Officer / Executive.
6.0 Forms and Records
6.1 Batch production and control record – Annexure- 1
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance
8.0 History