[RegAffairs]Re: USP versus in-house API specification

[Malcolm Ross <generapharm@gmail.com>]

As far as the US is concerned USP finished dosage forms, i.e. 
products are made with USP drug substances.

Therefore an API that does not comply with the USP cannot give a 
product that is USP.

As to question 3-after a USP monograph becomes official your product 
will need to comply with the new monograph. This can create 
considerable problems and issues which are beyond the scope of this 
discussion

Malcolm Ross
Generapharm-Training and Consultancy
Basel-CH