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 the supervision of analysis in the 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, and purity.
• Whether analysis has been done as per the specified pharmacopeia 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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