Retention [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-03-09 12:38 (38 d 17:31 ago) – Posting: # 22252
Views: 410

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.

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