SOP for Functions of Quality Control Department

OBJECTIVE:
To provide a documented procedure for functions of quality control department. 

SCOPE:
This procedure is applicable for functions of quality control department.

RESPONSIBILITY:
Primary : Chemist Quality Control department. 
Overall : Manager Quality control department 

PROCEDURE:
Following are the activities of quality control department. 
  • Testing and release or rejection of all incoming raw materials, packing materials, in-process / intermediates and finished products as per specified specifications. 
  • Maintaining testing records as per standard procedures for raw materials, packing materials, in-process / intermediates and finished products. 
  • Calibration of laboratory instrument / equipment. 
  • Performing stability study. 
  • Control sample storage. 
  • Analytical method validation. 
  • Preparation of standard volumetric solutions and maintain standardization record. 
  • Maintain Labeling procedure at all the stages and records. 
  • Maintain working / reference standard record of products. 
  • Analysis of complaint samples as and when required. 
  • To conduct technical audit / self-inspection. 
  • Follow safety norms at all the stage during handling of chemicals and using instruments. 
  • Follow good laboratory practices. 
REFERENCE: 
Nil 

ABBREVIATION:
Nil 

ANNEXURE:
Nil

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