Selection of Testing Materials
1 At first time of the validation for the analyst, the material with supplier’s test report (traceable to the authentic testing agency) will be taken as the testing material.2 Materials already approved by QC laboratory or supplier test report (traceable to the authentic testing agency) will be taken as testing material for routine validation exercise.
Procedure for Validation
1. For routine analysis, all analyst will undergo for validation exercise.2. Materials Under test with quality monograph (Standard Test Procedure) will be provided to each analyst.
3. Only quantitative test (Assay and other if any) will be considered for validation evaluation exercise but the entire test of STP will conduct by each analyst.
4. The analyst will provide test result to QC Manager in the due time of test period. In case of availability of only one instrument in the QC department time for analysis will be set accordingly.
5. No repeat of the test will be allowed to the analyst.
6. After completion of the test, the QC Manager will check the test result and fill the record in appendix-I of this SOP.
7. QC Manager will give his recommendation to the QA Manager.
8. QA Manager will review validation report and will decide for the selection of analyst for routine analysis. If the analyst is failed to qualify the test analyst will undergo training to testing equipment and test procedure.
9. After training analyst will under go re qualification exercise of analyst validation.
Interpretation
1 The result is provided by the analyst will be crosscheck to the previous result of the material and check the similarity of the result.2 If the material is not previously tested in the company by approved analyst the supplier report will be consider as acceptance criteria for validation exercise. If the analyst is failing to qualify the test, as per the vendor report, another approved analyst to confirm the result of the vendor report will do a repeat test.
3 In the case of three or more analyst are under evaluation then % Relative Standard Deviation will be taken for interpretation of the result. The % RSD should not more than 1%.
4 The result of the analyst should not very by defined acceptance criteria to actual result (test report) of the material.
5 Fill the result in the analyst validation report.
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Thanks sir for post
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