Saturday, November 27, 2010

Acceptance of raw materials on supplier certificate of analysis

1.0 0          1.0   Purpose    :   To provide instructions for acceptance of raw materials on supplier certificate of   analysis.

2.0              Objective  : To provide a documented procedure for the acceptance of raw materials on     supplier certificate of analysis.

3.0              Scope     :    This procedure for acceptance of raw materials on supplier certificate of analysis is applicable for QC Department  of -------- Pharmaceuticals Ltd, 

4.0         Responsibility   :
·        Primary:  QC Officer
·        Secondary:  Overall: Manager QA/QC
                    
5.0       Procedure     :
·    Some of raw materials having hazards / toxic nature, difficult to sampling or handling                can be released based on supplier certificate of analysis.
·   Hazards / toxic materials are used in ----- Pharmaceuticals Ltd. After receiving Goods Receipt Note from stores department, QC chemist enters the entry in raw material register and give AR No. to respective raw material.
·    Check the party’s certificate of analysis report.
·    QC Chemist checks physically the raw material’s container, labels and compare the batch details with certificate of analysis.
·        If all the details found OK, chemist make analysis report and then release materials by pasting approved labels.

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