Retention [Regulatives / Guidelines]

posted by Vuas – India, 2021-03-10 09:46 (144 d 20:40 ago) – Posting: # 22255
Views: 815

» 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.

Many thanks for response.
But for vaginal suppositories retention is given 30 units so we did studies with retention of 30 for rectal suppositories as well.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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