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RegisterAcceptance criteria of analytical run [Regulatives / Guidelines]
Dear Forum members,
As per EMA Guideline on bioanalytical method validation Acceptance criteria of an analytical run "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."
What if we have 12 QCs in run (3 replicates of each Low, Low-mid, Mid and High) and 1 replicate of each Low, Low-mid, Mid and High failed leading to pass 66.67% of QCs (8 out of 12).
May we accept the analytical run and considered as pass?
Regards,
Qualityassurance
As per EMA Guideline on bioanalytical method validation Acceptance criteria of an analytical run "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."
What if we have 12 QCs in run (3 replicates of each Low, Low-mid, Mid and High) and 1 replicate of each Low, Low-mid, Mid and High failed leading to pass 66.67% of QCs (8 out of 12).
May we accept the analytical run and considered as pass?
Regards,
Qualityassurance
Complete thread:
- Acceptance criteria of analytical runqualityassurance 2021-10-18 07:00 [Regulatives / Guidelines]
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Ing. Helmut Schütz