Bojan:
Several things:
a. US FDA does not approve API facilities. They just approve the finished
dosage form that contains the API. Failure of an API facility to meet GMPs
and their DMF commitments can result in the client's finished dosage form
not being approved;
b. US FDA does not issue documents or certificate equivalent to European
COS, or CEP's;
c. an EIR from 2003 is now 6-years old. FDA tries to reinspect overseas
facilities about every 2-3 years, but this is not strictly followed, and I
have some API clients who have not been re inspected for 7 years.
Additionally your API needs may be from the same factory, but from a
different workshop within the factory site, so a 2003 EIR does not help
much.
I spend a goodly part of my life traveling the world performing API facility
inspections on behalf of finished dosage form suppliers. If I can assist
please contact me offline at manisfeld@globepharm.org
With Best Regards,
Michael Anisfeld
Globepharm
e-mail: manisfeld@globepharm.org
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