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.