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RegisterFDA draft BMV guidance revision published [Regulatives / Guidelines]
Hi Ohlbe,
thanks for the link. Makes good reading.
I was hoping they would be more explicit about the required quality standard. In relation to human BA/BE they just refer to 21CFR320.29, which isn't so informative and leaves a lot of room for interpretation. Most analytical validations from US-based CROs I have seen do actually include a GLP compliance statement. Arguably there is a bit of scope clutter with 21CFR58, though.
thanks for the link. Makes good reading.
I was hoping they would be more explicit about the required quality standard. In relation to human BA/BE they just refer to 21CFR320.29, which isn't so informative and leaves a lot of room for interpretation. Most analytical validations from US-based CROs I have seen do actually include a GLP compliance statement. Arguably there is a bit of scope clutter with 21CFR58, though.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- FDA draft BMV guidance revision published Ohlbe 2013-09-12 15:44
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA draft BMV guidance revision published Helmut 2013-09-12 16:22
- FDA draft BMV guidance revision publishedElMaestro 2013-09-12 17:23
- Crystal City 5 Ohlbe 2013-09-25 22:34
- BLQ = 0?! Helmut 2013-09-25 23:15
- Deadline approaching Helmut 2013-12-04 22:02
Ing. Helmut Schütz