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VP ☆ 2010-01-06 12:38 (6011 d 05:54 ago) Posting: # 4564 Views: 3,087 |
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Dear all We have completed method validation for one drug. QA has done inprocess audit of validation but we did not submit the data after completion of validation to to QA for retrospective audit. Can we start subject sample analysis (for same drug) before QA audit. if yes/no any referance is there for same? Is it necessary to file any note to file or SOP deviation for same? Thanks & regards VP |
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Debbie ★ India, 2010-01-06 18:01 (6011 d 00:31 ago) @ VP Posting: # 4566 Views: 2,379 |
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Dear VP, i think its better practice to start the subject sample analysis after the QA review of the method validation. If the study is for european region, i may caution you, as we had an experience of getting the observation for the same issue from an european regulatory authority. regarding the reference, it may be a better GLP practice of having full confidence and certification (from your independent QA) of your method performance before starting the subject sample analysis. for the documentation, all depends on what your SOP says about your procedures/practices. Regards, Debbie |
Ing. Helmut Schütz