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.

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