20% of randomly chosen chromatograms - In any Guideline? [Bioanalytics]

posted by ElMaestro  – Denmark, 2018-06-04 10:51 (1231 d 15:38 ago) – Posting: # 18852
Views: 5,990

Hi Obi,

» » Make sure to have an SOP which gives an objective way to select them.
»
» Yea, the draft FDA Guideline did state that. But it was not stated in the final FDA guideline.....strange.

Isn't this to some extent to the wrong philosophy? Those chromatograms are an essential part of your submission, so of course the matter should be covered by an SOP, whether or not the need for an SOP is stated explicitly in the guidance. I see it that way.:-)

Pass or fail!
ElMaestro

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