Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2021-10-18 12:36 (341 d 12:46 ago) – Posting: # 22634
Views: 1,431

(edited by dshah on 2021-10-18 19:13)

Dear Qualityassurance!
I believe that the run shall be rejected. As per guidlence-" In case these criteria are not fulfilled the analytical run should be rejected, and the study samples re-extracted and analysed." Further the CRO's SOP is equally important as many times the SOP's are stringent compared to guideline (to keep a single SOP for many regulaotries).

» 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:

The point of interest is weather all the QC's in same sequence failed? There could be error in sampling sequence or levels failed in different sequence?
Ideally 1 more passes sample to meet the acceptance criteria may have qualified the analytical run.

Complete thread:

UA Flag
 Admin contact
22,385 posts in 4,684 threads, 1,594 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time: Sunday 01:22 CEST (Europe/Vienna)

You really don’t know what you don’t know until you write about it.
Then, everyone knows what you don’t know.    Rod Machado

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