STANDARD OPERATING PROCEDURE ISSUANCE OF BATCH MANUFACTURING RECORDS

STANDARD OPERATING PROCEDURE

SUBJECT:                      ISSUANCE OF BATCH MANUFACTURING RECORDS

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

                       

To provide guidelines for the issue of Batch Manufacturing Records.

2.0       POLICY:

Batch Manufacturing Records are the historical record of each Batch manufactured.

           

3.0       PROCEDURE:

3.1       Duly approved copies of the MBMR will be provided by Principle Representative.

3.2       Every Batch will be produced in accordance with the BMR which is a verified photostat copy of the appropriate MBMR.

3.3       The BMR & PDR for the specific pack planned will be issued to production on request after consulting the ware house on the availability of approved raw and packing materials.

3.4       Q.A executive will write the S.No. & Batch No. on each BMR as per the Production plan and issue to the Production dept. Record for BMR issue is maintained by QA.

3.5       After the issue of BMR & PDR the production executive will contact ware house for issue of raw material and packing material for the batch planned.

3.6       The aware house executive will check the raw materials and packing materials, post the issue in the issue register and issue the raw materials and packing materials for the specific batch in presence of the production & QA executives.

3.7       There will be a cross check by production and QA executives at the time of issue of raw and        

packing materials.

3.              All R.Ms issued for the manufacture of the specific batch should move at a time from ware house to production area.

3.9       All entries in the BMR and PDR should be done online while manufacturing and packing operations.

3.10     The completed BMR and PDR should be placed in the batch history record envelope and returned to QA department.

3.11     The production executive should sign the record and return the completed BMR to QA.

4.0       FREQUENCY:  As and when required.

5.0       RESPONSIBILITY: G.M (Q.A) / Executive (Q.A)/Production executive.

6.0       REVIEW GUIDE:  BMR Issue record.

7.0       ANNEXURE: 1. Issuance of batch manufacturing records.

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	√
Warehouse	x	x
General	x	x
Maintenance	x	x