Retention samples [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2021-04-13 21:07 (1164 d 00:15 ago) – Posting: # 22308
Views: 2,311

Dear Vinodvasala!

Please search in forum for previous discussions  ,  ,  . In general as per Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)- 30 units for Drug Products Manufactured in Single-Dose Units or 3 units for Drug Products Manufactured in Multi-Dose Units for US regulatory and 300 units for 5X testing (safer approach).
Regards,
Dshah

Complete thread:

UA Flag
Activity
 Admin contact
23,059 posts in 4,841 threads, 1,646 registered users;
31 visitors (0 registered, 31 guests [including 6 identified bots]).
Forum time: 21:23 CEST (Europe/Vienna)

Friends don’t let friends use Excel for statistics!    Jonathan D. Cryer

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