Saturday, November 20, 2010

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

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