Friday, December 24, 2010

Procedure For Review And Approval Of Analytical Raw Data

PROCEDURE  
                   
          4.1. The reviewer shall ensure the following at the time of reviewal of the documents.

            4.1.1.  All the relevant details of the tested material.

             4.1.2.  Correct & Current Specification No.

            4.1.3.   All the tests are performed as per the required specifications.

4.1.4.    Correct use of working standard and its potency along with WS..No.

4.1.5.     Correct use of HPLC columns.

4.1.6.     All print- out chromatograms duly signed & dated by the Analyst should be attached.

4.1.7.     The raw data shall contain the Instrument No, used for the analysis.

4.1.8.    Correct Normality is used.

4.1.9    Correct units for measurements are mentioned.

         4.2.     The reviewar shall also ensure for the following,

         4.2.1.      Rounding off the results is done.

        4.2.2.     Correctness of the calculations.

       4.2.3.     Justifications for discarding the data ( if any )

                   4.2.4.  After going through the above mentioned requirements, the reviewers shall put his Signature    
             & date on the raw analytical data. 

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