STANDARD OPERATING PROCEDURE AUTHORIZING TECHNICAL STAFF TO ATTEST VARIOUS DOCUMENTS

STANDARD OPERATING PROCEDURE

SUBJECT :                     AUTHORIZING TECHNICAL STAFF TO  ATTEST VARIOUS DOCUMENTS

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

1.0       OBJECTIVE:

To provide guidelines for the Authorizing Approved Technical staff, Supervisors, QA staff, Ware House, Operators to attest various documents.

2.0                   SCOPE: 

To lay down a procedure for authorizing above staff to attest various Documents.

3.0                   PROCEDURE:

3.1        All documents prepared in each department need to be attested indicating the preparation, completion of the document. The signature should match the signature mentioned in the annexure -1 of this SOP.

             Ware House Documents: Preparation of Goods Inward Notes, RM &PM dispensing records, RM &PM issue records; statements etc... Need to be signed off by Ware House Executives online.

             All Finished Goods dispatch documents like Gate Pass Invoice etc... RG1, RT12 etc…, prepared at the time of dispatch need to be signed off by Excise Executives.

3.2        Manufacturing, Packing documents: All supporting documents like BMR, BPR, in process documents, cleaning recodes, pest control records, H.K records will be signed off online by the production executive, supervisors, operators.

3.3       QA in process documents: All in process test documents like in process checks during processing, packing, inspection reports will be signed off online by the QA executive BMR and BPR issue records.  

3.4      Only Staff approved by Drug Control Authority of Telangana State are authorized to sign off the

           Final BMR, BPR, Finished Product reports, Certificate of analysis of Raw material.

3.5       The signatures of various staff members will be verified by QA         randomly once in quarter and recorded will be maintained.

                       

4.0       FREQUENCY:  Every Quarterly.

5.0       RESPONSIBILITY: All concerned.

6.0       REVIEW GUIDE: ----------

7.0       ANNEXURE: 1. Authorizing technical staff to attest various documents.

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	√
General	x	√
Maintenance	x	√