Retention samples [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2021-04-13 19:07 (488 d 14:30 ago) – Posting: # 22308
Views: 1,768

(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:

UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Monday 09:38 CEST (Europe/Vienna)

Science… never solves a problem
without creating ten more.    George Bernard Shaw

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