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RegisterQC acceptance criteria in Validation Runs [Bioanalytics]
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
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
Complete thread:
- QC acceptance criteria in Validation Runsnajatmughrabi 2009-01-28 07:41
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