Acceptance of raw materials on supplier certificate of analysis.

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

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

3.        Scope: This procedure for acceptance of raw materials on supplier certificate of analysis is applicable for QC Department.

4.      Responsibility   :

·        Primary:  QC Officer

·        Secondary:  Overall: Manager QA/QC                   

5.       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 K.A. Malle Pharmaceuticals Ltd. After receiving Goods Receipt Note from stores department, QC chemists enter 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 compares 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.