Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – 2021-10-19 17:25 (914 d 03:38 ago) – Posting: # 22641
Views: 2,030

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
22,988 posts in 4,825 threads, 1,655 registered users;
44 visitors (0 registered, 44 guests [including 7 identified bots]).
Forum time: 21:03 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

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