Bioequivalence and Bioavailability Forum

Hi Samar,

❝ […] should we include quality control samples in each validation run (matrix effect, Reccovery, stability,,, )?

Counter question:

If you would not include QCs in these runs how could you know whether their results are valid?

Hi samar sameh,

Matrix effect and recovery can as far as I know be evaluated without the use of a calibration curve and without regulators bashing you. I am thinking there is no harm in injecting the curve, but it isn't particularly informative if the QCs pass on it in those cases. That a run is approved by way of QC's does not necessarily imply that the run is qualified for a type of experiment that does not hinge on analyte divided by internal standard.

For stabilities I think you have often a plain injection of the curve. Hence you inject QC's in such runs.

Hello Samar:

❝ According to EMA and FDA guidlines, should we include quality control samples in each validation run (matrix effect, Reccovery, stability,,, )?

QCs must be include within study samples but not in each validation run: "An analytical run consists of the blank sample (processed matrix sample without analyte and without IS) and a zero sample (processed matrix with IS), calibration standards at a minimum of 6 concentration levels, at least 3 levels of QC samples (low, medium and high) in duplicate (or at least 5% of the number of study samples, whichever is higher), and study samples to be analysed" EMA Guideline

As Helmut and ElMaestro have said there are validation paramaters that do not requires QCs (selectivity, matrix effects...)