SOP FOR ANALYST VALIDATION

I.          PURPOSE

To describe the procedure for Validation of Analyst.

II.        SCOPE

This SOP is applicable to all the Analysts working in Quality Control department, , Unit-V.

III.       RESPONSIBILITY

Executive - Quality Control

IV.       ACCOUNTABILITY

Incharge  - Quality Control

V.        PROCEDURE

1.0       A new Analyst should be trained as per ‘Validation identification matrix’

           Format No.: F01/SOPQC002-00 under executive who had already validated.

2.0      This training should be continued until he is competent enough to carryout the analysis 

            Independently.

3.0      Analyst validation should be performed as follows

3.1      Incharge or his deputy should select the product with respect to the identified GTPs   That is, in which the particular test is included.

3.2      Incharge or his deputy should select three recently approved samples of the same              product, label as ‘Sample-1, Sample-2, Sample-3, allot them to analyst for analysis.

3.3      Batch No.s and previous analysis results should be tabulated confidentially in the        ‘Analyst Validation protocol’ Format No.:F02/SOPQC002-00.

3.4      Analyst should analyze the three samples for all the tests as per ‘Validation      Identification matrix’.

3.5      Trainer should ensure that the Analyst is performing the tests as per respective                  Standard Testing Procedure and General testing procedure.

3.6          Incharge or his deputy shall enter the results in ‘Analyst validation protocol’ .         

3.7          The results should be compared against the previous results.

3.8        Wherever the numeric values are applicable, the value should not be varied  more     

              than 1% with the previous results.

3.9          Where the numeric values are not applicable, the results should match with the     

              previous result.

3.10      Incase of Total microbial count the result should not be varied more than 10.00%.

3.11      If the results are not with in the limits, analyst should be retrained and revalidated.

           4.0     List of Formats

Format No.	Title
F01/SOPQC002-00	Validation Identification Matrix
F02/SOPQC002-00	Analyst Validation Protocol

VI.      REVISION SUMMARY

Version No.	Revised on	Reason for Revision
00	NA	NA

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