Bioequivalence and Bioavailability Forum • Non-accuracy and precision validation runs as per M10 guideline

avinash
★

India,
2023-07-27 15:16
(651 d 20:27 ago)

Posting: # 23686
Views: 2,214

Non-accuracy and precision validation runs as per M10 guideline [Regulatives / Guidelines]

Dear Members

As per ICH M10 guideline,

For non-accuracy and precision validation runs, low, medium and high QCs may be analysed in duplicate. These QCs, along with the calibration standards, will provide the basis for the acceptance or rejection of the run.

Non-accuracy and precision validation run also includes Selectivity batch. In this context what is the relevance of having low, medium and high QCs in selectivity run? Should Selectivity be considered as a Non-accuracy and precision batch?

Please opine.

Thanks & regards,
Avinash