Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – 2021-10-21 18:51 (1007 d 08:47 ago) – Posting: # 22651
Views: 2,553

Dear Ohlbe,

❝ 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.

Yes. Will update the SOP and then when ICH M10 will be finalized our SOP already in line with the guideline.:cool:


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