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.