Retention [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-03-09 14:38 (1141 d 14:13 ago) – Posting: # 22252
Views: 2,030

Hi Vuas,

❝ … can we proceed for minimum sample retention quantity of 30 units each for test and reference products?


See lines 63–65:

21 CFR 320.38(c) requires that applicants retain reserve samples of the test product and reference standard used in a BA or BE study that consist of a sufficient quantity to perform five times all the release tests required in the application or supplemental application.

(my emphasis)
If your test requires six units, 30 are fine. See also the guidance Handling and Retention of BA and BE Testing Samples.

To lift your mood: [image] The Suppository Song

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,993 posts in 4,828 threads, 1,657 registered users;
86 visitors (0 registered, 86 guests [including 7 identified bots]).
Forum time: 05:52 CEST (Europe/Vienna)

So far as I can remember,
there is not one word in the Gospels
in praise of intelligence.    Bertrand Russell

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