Validation and Subject sample analysis [Bioanalytics]

posted by VP – 2010-01-06 12:38 (6014 d 08:02 ago) – Posting: # 4564
Views: 3,091

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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