Incurred Sample Reanalysis Guidance
CRYSTAL CITY III: INCURRED SAMPLE REANALYSIS: NOT IF BUT HOW
Recent FDA audits have shown that incurred sample reanalysis (ISR) sometimes yielded dramatically different results, even when using a validated assay. In order to identify these cases, it has been determined that the reanalysis of a limited number of incurred samples be systematically verified and should be part of assay validation.
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