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SOP for Instructions for Supervision of Analysis

Objective
To provide a documented procedure for supervision of analysis.

Purpose 
To provide instructions for supervision of analysis.

Scope
This procedure is applicable for supervision of analysis in QC department.

Responsibility
Primary: Officer – QA / Officer-Store
Secondary: Officer – QA Manager.

Procedure
  • Spot-check once a week all registers, reagents and volumetric standard solutions.
  • Frequently observe the actual testing done by the chemist.
  • Review analytical reports and before signing check and confirm for:
  • Complete entries in to the logbooks, test data sheets etc.
  • Reagents should be stored in bottles.
  • Reference / working standards stored in desiccators should be checked for details like name, date of preparation, date of expiry, purity.
  • Whether analysis has been done as per the specified pharmacopoeia or in-house specifications (if specified).
  • If not found to comply, necessary action to rectify / modify the procedure can be taken.
Annexure
Nil

Revision History
Nil

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