STANDARD OPERATING PROCEDURE APPROVAL OF BATCH PRODUCTION RECORDS

STANDARD OPERATING PROCEDURE

SUBJECT:                      APPROVAL OF BATCH PRODUCTION RECORDS

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

1.0       OBJECTIVE:

                       

1.1       To provide complete and permanent Records of Manufacturing of every Product.

1.2          To provide data on the Batch Yield for costing purpose and to provide means of Production reporting.

1.3       To ensure as a check on GMP.

1.4       To serve as a Raw material issue note.

1.5       To serve as In-process control record.

2.0       POLICY:

Complete Batch Production record should be duly approved by FDA approved Chemist.

3.0       PROCEDURE:

3.1       Upon completion of the Bulk Manufacturing the Production Manager will ensure the

following checks.

3.1.1    All the entries in the BMR are completed.

3.1.2    Reconciliation of Actual vs. Theoretical Bulk yield.

3.1.3      Review of all the documents e.g. In process, control charts, temperature, humidity charts,

tags, weights, moisture etc., records. On completion of the above action, BMR would be sent to

Production Manager who would recheck entries for accuracy. He will sign and send the BMR

to G.M (Q.A).  G.M (Q.A) will examine the BMR for accuracy and completeness and ensure

the following:  Yield recorded is within the established limits. Accuracy of the date of manufacturing and expiry date wherever applicable. If the Batch meets all the parameters as per the specifications the BMR will be signed by GM – QA and it will be released for dispatch, G.M (Q.A) will affix APPROVED stamp on the BMR.                                                                                                                                      

The Q.A will give an approval tag. If the Batch does not meet all the parameters as per the specifications, complete review of the BMR will be made by Q.A or Production dept to assess what corrections are to be made.

Incase of minor corrections, G.M (Q.A) in concurrence with Production Manager Principle representative will enter the instructions for the corrections on the BMR and initial / date his instructions and return the BMR to Production. Production Manager / Supervisor in turn correct the document & return back to QA.

3.5       Q.A shall securely store copy of the BMR for a period of 12 months beyond the expiry of the product and format is included in Annexure.

4.0       FREQUENCY:  As and when required.

5.0       RESPONSIBILITY: G.M (Q.A), Manager Production.

6.0         REVIEW GUIDE: BMR of the completed Batch of Product will serve as a Reference document.

7.0       ANNEXURE: ------

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