najatmughrabi
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2009-01-28 08:41
(6355 d 08:52 ago)

Posting: # 3149
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 QC acceptance criteria in Validation Runs [Bioanalytics]

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Dear All ;-)
Kindly advice if from MHRA point of view the QC acceptance criteria for method validation is different from that of a normal run? Usually we use the following acceptance criteria for both a routine run and validation runs, yet a European customer stated that the MHRA does not accept this and we should have two acceptance criterion (one for validation and one for routine analytical runs):
±20.00% for QCs at LLOQ and ±15.00 % for QCs at Low / Mid / High concentrations,
accepted ratio is 50% of each level and 67% for the total.
Have anyone encountered this? And what would be the acceptable acceptance criteria from MHRA point of view
Thank you and best regards
Najat ;-)
 
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