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RegisterRetention [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2021-03-09 13:38 (473 d 14:12 ago) – Posting: # 22252
Views: 1,605
Hi Vuas,
» … can we proceed for minimum sample retention quantity of 30 units each for test and reference products?
See lines 63–65:
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]](https://static.bebac.at/img/youtube.png)
The Suppository Song
» … 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:
The Suppository Song—
Dif-tor heh smusma 🖖![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Retention Vuas 2021-03-05 19:02 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- RetentionHelmut 2021-03-09 13:38
- Retention Vuas 2021-03-10 09:46
- RetentionHelmut 2021-03-09 13:38
Ing. Helmut Schütz