Monday, November 29, 2010
Functions of Quality Control Department
1.0 Purpose : To provide an instruction for functions of quality control department.
2.0 Objective : To provide a documented procedure for functions of quality control department.
3.0 Scope : This procedure is applicable for functions of quality control department --- Pharmaceuticals Ltd,
4.0 Responsibility :
· Primary: QC Chemist / QC-Officer
· Secondary : Overall: QC – In charge
5.0 Procedure :
· List of activities of quality control department.
Ø Testing and release or rejection of all incoming raw materials, packing materials, in-process / intermediates and finished products as per specified specifications.
Ø Maintaining testing records as per standard procedures for raw materials, packing materials, in-process / intermediates and finished products.
Ø Calibration of laboratory instrument / equipment.
Ø Performing stability study.
Ø Control sample storage.
Ø Analytical method validation.
Ø Preparation of standard volumetric solutions and maintain standardization record.
Ø Maintain Labeling procedure at all the stages and records.
Ø Maintain working / reference standard record of products.
Ø Analysis of complaint samples as and when required.
Ø To conduct technical audit / self-inspection.
Ø Follow safety norms at all the stage during handling of chemicals and using instruments.
Ø Follow good laboratory practices.