Bioequivalence and Bioavailability Forum • Acceptance criteria of analytical run

Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by Ohlbe – France, 2021-10-19 20:54 (1059 d 10:03 ago) – Posting: # 22642
Views: 2,990

Dear Qualityassurance,

❝ May we specify in our SOP that 2/3 (67%) of the QC should be within ±15% of the nominal values? or It is advisable to reject such runs (having 66.67% passed QCs)?

You can very well write in your SOP acceptance criteria of 2/3 and 50% at each level of concentration. By the way, the ICH M10 draft guideline (step 2, public consultation now ended) has dropped the awkward 67% criterion and replaced it with 2/3. We'll see what is decided in the final guideline.

I have never heard of any regulatory authority (at least in Europe or Northern America) raising a question or a deficiency because a run was validated with 8/12 QCs passing (with 50% at each level of concentration) and objecting that this is < 67%.

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Regards
Ohlbe

Complete thread:

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