Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – Jordan, 2021-10-18 07:00 (250 d 21:01 ago) – Posting: # 22631
Views: 1,520

Dear Forum members,

As per EMA Guideline on bioanalytical method validation Acceptance criteria of an analytical run "The accuracy values of the QC samples should be within ±15% of the nominal values. At least 67% of the QC samples and at least 50% at each concentration level should comply with this criterion."

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:


Complete thread:

UA Flag
 Admin contact
22,167 posts in 4,645 threads, 1,572 registered users;
online 11 (0 registered, 11 guests [including 5 identified bots]).
Forum time: Sunday 04:02 CEST (Europe/Vienna)

The person interested in success has to learn
to view failure as a healthy, inevitable part
of the process of getting to the top.    Joyce Brothers

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