Bioequivalence and Bioavailability Forum

Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2021-10-18 08:35 (51 d 03:51 ago) – Posting: # 22632
Views: 668

Hi quallityassurance,

» 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?


I think the run passed when 2/3 were ok.
I agree the wording leads to some confusion but here you should be ok. 2/3 in unrounded percent is 67.

Complete thread:

• Acceptance criteria of analytical run qualityassurance 2021-10-18 07:00 [Regulatives / Guidelines] 
  • Acceptance criteria of analytical runElMaestro 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