FDA regulations for chemicals used in drug/biologics manufacture
(by stewjw from gmail.com)
Thu Jan 31 14:35:04 EST 2008
For Drug/Biologics manufacture you have to quarantine and test the
chemicals used in the manufacturing process. From what little I've
read the nature of the tests is not written in stone by the FDA. But
my real question is are there restrictions on the grades of chemicals
used in the manufacturing process, do they need to be BP or USP grade
or is this just a preference. Can laboratory grades such as Analar
also be used?
Also, is the FDA still producing the Orange book guidelines?
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