Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2021-10-18 08:35 (51 d 03:51 ago) – Posting: # 22632
Views: 668

Hi quallityassurance,

» What if we have 12 QCs in run (3 replicates of each Low, Low-mid, Mid and High) and 1 replicate of each Low, Low-mid, Mid and High failed leading to pass 66.67% of QCs (8 out of 12).
»
» May we accept the analytical run and considered as pass? :confused::confused:


I think the run passed when 2/3 were ok.
I agree the wording leads to some confusion but here you should be ok. 2/3 in unrounded percent is 67. :-)

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,788 posts in 4,557 threads, 1,548 registered users;
online 10 (0 registered, 10 guests [including 5 identified bots]).
Forum time: Wednesday 11:26 CET (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5