[RegAffairs]RE: Stability testing

["Peter Geffen" <pgeffen@dpharm.com>]

The EMEA GUIDELINE ON DECLARATION OF STORAGE CONDITIONS
(http://www.emea.europa.eu/pdfs/human/qwp/060996en.pdf) is very clear
how to state the storage conditions label based on the stability study
results at 25/60, 30/65, 40/75 or whatever has been done.  There's an
option to warn against refrigeration or freezing when necessary.
I'm not aware of an FDA equivalent, although I think the recommendations
would be acceptable by them.

Best regards,
Peter Geffen
D-Pharm