RE: Viral safety test validation Contribution from Mike Edgington written on 4/18/2002 at 17:15
Original contribution: Viral safety test validation written by Paola Gnemi on 4/17/2002 at 11:34) I should be able to supply some help but a more specific question(s) would help me to give more specific information.
The critical aspects of virus testing are establishing the limit of detection (LOD) for a particular virus assay, and secondly demonstrating that the test matrix does not interfer with LOD. Reference should be made to ICH Q5A virus safety or USP 25 <1050> for estimating the probabilities of virus detection.
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