Retention samples [Regulatives / Guidelines]

posted by dshah – India, 2021-04-13 19:07 (100 d 23:15 ago) – Posting: # 22308
Views: 1,338

(edited by dshah on 2021-04-13 19:19)

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:

Activity
 Admin contact
21,589 posts in 4,512 threads, 1,530 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time: Friday 18:23 CEST (Europe/Vienna)

Statistics is the grammar of science.    Karl Pearson

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