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

posted by ElMaestro  – Belgium?, 2018-06-04 10:51 (874 d 04:22 ago) – Posting: # 18852
Views: 5,079

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.:-)

I could be wrong, but...

Best regards,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

Complete thread:

 Admin contact
21,179 posts in 4,414 threads, 1,474 registered users;
online 3 (0 registered, 3 guests [including 1 identified bots]).
Forum time: Sunday 14:13 CET (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz