Retention of Sample-USFDA [GxP / QC / QA]

posted by kapil pandya – 2010-11-12 13:38 (5695 d 01:44 ago) – Posting: # 6141
Views: 6,831

The sponsor may not reveal the quantity of in-vitro tests for the sake of confidentiality, but they may provide a statement that the remaining quantity of IP is sufficient for retention as per USFDA guideline.

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,571 registered users;
145 visitors (0 registered, 145 guests [including 26 identified bots]).
Forum time: 16:22 CEST (Europe/Vienna)

Always listen to experts.
They’ll tell you what can’t be done and why.
Then do it.    Robert A. Heinlein

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