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RegisterRetention samples [Regulatives / Guidelines]
Dear Priyanka,
As per USFDA guidance, "The quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application. "
Same need to follow.
Edit: Guidance linked. [Helmut]
As per USFDA guidance, "The quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application. "
Same need to follow.
Edit: Guidance linked. [Helmut]
Complete thread:
- Retention samples priyanka12345 2018-05-09 15:57 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Retention samplesanky1212 2018-05-31 13:29
Ing. Helmut Schütz