Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – Jordan, 2021-10-18 07:00 (96 d 16:04 ago) – Posting: # 22631
Views: 920

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? :confused::confused:


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