Bioequivalence and Bioavailability Forum

Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – 2021-10-18 09:00 (915 d 09:14 ago) – Posting: # 22631
Views: 2,570

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

Complete thread:

• Acceptance criteria of analytical runqualityassurance 2021-10-18 07:00 
  • Acceptance criteria of analytical run ElMaestro 2021-10-18 08:35
  • Acceptance criteria of analytical run dshah 2021-10-18 12:36
    • Acceptance criteria of analytical run qualityassurance 2021-10-19 15:25
      • Acceptance criteria of analytical run Ohlbe 2021-10-19 18:54
        • Acceptance criteria of analytical run qualityassurance 2021-10-21 16:51
  • Acceptance criteria of analytical run Ohlbe 2021-10-18 14:43
    • ’Percentage’ of few values Helmut 2021-10-20 14:06
      • ’Percentage’ of few values qualityassurance 2021-10-21 16:57