Non-accuracy and precision validation runs as per M10 guideline [Regulatives / Guidelines]

posted by avinash – India, 2023-07-27 15:16 (352 d 11:18 ago) – Posting: # 23686
Views: 1,458

Dear Members

As per ICH M10 guideline,

For non-accuracy and precision validation runs, low, medium and high QCs may be analysed in duplicate. These QCs, along with the calibration standards, will provide the basis for the acceptance or rejection of the run.

Non-accuracy and precision validation run also includes Selectivity batch. In this context what is the relevance of having low, medium and high QCs in selectivity run? Should Selectivity be considered as a Non-accuracy and precision batch?

Please opine.

Thanks & regards,
Avinash

Complete thread:

UA Flag
Activity
 Admin contact
23,099 posts in 4,857 threads, 1,646 registered users;
90 visitors (0 registered, 90 guests [including 8 identified bots]).
Forum time: 02:35 CEST (Europe/Vienna)

Genius is one per cent inspiration and ninety-nine per cent perspiration.
Accordingly, a ‘genius’ is often merely a talented person
who has done all of his or her homework.    Thomas Alva Edison

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