non-accuracy and precision validation runs in ICH M10 guideline [Regulatives / Guidelines]

posted by avinash – India, 2023-06-30 11:28 (154 d 10:43 ago) – Posting: # 23636
Views: 1,374

Dear Members

This is with regard to ICH M10 guideline

Under section, “Accuracy and Precision”, 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.

Here does non-accuracy and precision validation runs means all other runs except accuracy and precision runs, which includes selectivity, specificity, matrix effect, carry-over, dilution integrity, stability and reinjection reproducibility?

Please help me to understand what is non-accuracy and precision validation runs?

Thanks & regards,

Edit: Guideline / Section linked. [Helmut]

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