Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by Ohlbe – France, 2021-10-19 18:54 (49 d 17:02 ago) – Posting: # 22642
Views: 631

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%.

Regards
Ohlbe

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