Monday, November 29, 2010

Record Maintained by Quality Control

1.0      Purpose      :    To provide instructions for record maintained by quality control department.

2.0      Objective  :  To provide a documented procedure for record maintained by quality control department.

3.0         Scope       :      This procedure is applicable for record maintained by quality control department --- Pharmaceuticals Ltd., 

4.0         Responsibility  :

·       Primary        :     QC Chemist / QC Officer
·       Secondary    :      Overall : QC In Charge

5.0       Procedure   :
·       Following are control documents.
Ø            Standard Operating Procedures of Quality Control Department..
Ø            Specifications of Raw material.
Ø            Specifications of Packing material.
Ø            Specifications of In-process / intermediate.
Ø            Specifications of Finished product.
Ø            Standard Test Procedures of Raw material.
Ø            Standard Test Procedures of Packing material.
Ø            Standard Test Procedures of In-process / intermediate.

Ø            Standard Test Procedures of Finished product.
Ø            List of Instruments.
·        Following are records.
Ø            Raw materials testing records.
Ø            Packing materials testing records.
Ø            In-process / intermediates testing records.
Ø            Finished products testing records.
Ø            Instrument calibration records.
Ø            Stability study records.
Ø            Instrument calibration records.
Ø            Glassware calibration records.
Ø            Raw material inward logbook
Ø            Raw material work sheet issuance logbook.
Ø            Intermediate inward logbook.
Ø            Intermediate work sheet issuance logbook.
Ø            Finished product inward logbook.
Ø            Finished product work sheet issuance logbook.
Ø            In process samples inward logbook.
Ø            Instrument uses logbooks.
Ø            HPLC column logbook.
Ø            Stability chamber logbook.
Ø            Laboratory cleaning logbook.
Ø            Volumetric solution logbook.

Ø            Standard reagent solution logbook.
Ø            Indicator logbook.
Ø            Retention sample logbook.
Ø            Logbook issuance logbook.

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