Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – Jordan, 2021-10-19 17:25 (412 d 04:51 ago) – Posting: # 22641
Views: 1,420

Dear dshah, ElMaestro and Ohlbe,

Thank you for the response.

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).

May we specify in our SOP that 2/3 (67%) of the QC should be within ±15% of the nominal values? or It is advisable to reject such runs (having 66.67% passed QCs)?

Regards,
Qualityassurance

Complete thread:

UA Flag
Activity
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
15 visitors (0 registered, 15 guests [including 10 identified bots]).
Forum time: 21:16 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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