What to do if QC sample concentration doesn't fall within the desired range - (Nov/25/2013 )
EMEA: Guideline on bioanalytical method validation (2011) make a mention in page 12 " At least 2 QC sample levels should fall within the range of concentrations measured in study samples"
If I want to add 1 concentration level of QC samples to cover study samples, I will conduct a partial validation including a run including a calibration curve and a minimum of 5 samples (replcation) of QC sample. Is this way suitible? Or how can I do to fit this guideline?
Please give me some suggection, thanks.
Have you tried doing that? or you are just about to? I think it's fine.