Bioanalytical method validation [Bioanalytics]

posted by qualityassurance – 2022-06-01 13:47 (548 d 14:11 ago) – Posting: # 23035
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❝ The analytical investigator said that the results can be accepted as per in-house sop, and the “Bioanalytical Method Validation Guidance for Industry” of USFDA and “Guideline on bioanalytical method validation” of EMA if the accuracy (% nominal) at each level be ± 15%.

IMHO (definitely others may have different opinion than me) first of all your in house SOP should be updated to include acceptance criteria for each run with respect to calibration curve and quality control samples during validation. So for QC following criteria should be applied for each and every run during validation. "The accuracy values of the QC samples should be within ±15% of the nominal values. At least 67% of the QC samples and at least 50% at each concentration level should comply with this criterion."

Scientifically experiment should not be accepted as QCs are deviating from their nominal value which clearly indicate the stability issues or might be preparation error. As per data it seems mostly it is preparation error since the deviation of stability QCs are not in trend.


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