Author Topic: Sterile starting materials with no second test by the pharmaceutical company  (Read 1428 times)


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Dear Forum members,
My question is relating the fact, that a same company manufactures a sterile API, steril excipient  and a sterile pharmaceutical bulk product, and send it to me (it has the autotization for all activities done)

So, there’re only one analysis of the API and sterile excipient.  Is it possible to accept that the starting materials are tested only once, by its maker?, And used in the manufacture of a drug without further testing? since both processes are performed in the same company and API and bulk are manufactured in continuos.
Can be it accepted in the Register of the drug?

Thanks in advance,
« Last Edit: October 06, 2012, 05:37:39 PM by PharmWeb »


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