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RegisterAcceptance criteria of analytical run [Regulatives / Guidelines]
Dear Qualityassurance,
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%.
❝ 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
Regards
Ohlbe
Complete thread:
- Acceptance criteria of analytical run qualityassurance 2021-10-18 07:00 [Regulatives / Guidelines]
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Ing. Helmut Schütz