change in CC range [Regulatives / Guidelines]

posted by sushil.pimpare – India, 2017-05-31 11:31 (2494 d 01:04 ago) – Posting: # 17429
Views: 7,527

As per applicable method validation, validated CC range for Analyte X is 10.0 ng/ml to 11015.9 ng/ml, 15.1 ng/ml to 6037.2 ng/ml for Y Analyte and 0.20 ng/ml to 9.84 ng/ml for Z Analyte however during subject sample analysis CC range used is 10.0 ng/ml to 11031.0 ng/ml, 15.1 ng/ml to 6039.8 ng/ml and 0.20 ng/ml to 9.96 ng/ml for X, Y and Z respectively which is outside the validated CC range.
I just wanted to confirm whether this is acceptable or not? also wanted to know is there any acceptable % deviation mentioned in any guideline related to change in CC range which found during method validation and subject sample analysis.


Edit: Please follow the Forum’s Policy. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
102 visitors (1 registered, 101 guests [including 6 identified bots]).
Forum time: 11:36 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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