Instructions for supervision of analysis.

1.0         Purpose     :     To provide instructions for supervision of analysis.

2.0         Objective   :     To provide a documented procedure for supervision of analysis.

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

4.0         Responsibility  :

·        Primary: Officer – QA / Officer-Store

·         Secondary: Officer – QA Manager.

5.0       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.

6.0      Reference Document  : Not Applicable.

7.0      Abbreviations  :

·        QA   = Quality Assurance

·        SOP = Standard Operating Procedure

·        QC = Quality Control

8.0      Copies to Distribution Sites.  :

·        QA –Ankleshwar

·        QC – Ankleshwar