Tuesday, April 12, 2016
IPEC-Americas has prepared a position paper on this issue to assist MAHs in Europe in meeting their risk assessment obligations as defined in the EU Guidelines.
The Guidelines call for MAHs to determine appropriate excipient GMP, determine their excipient manufacturers’ risk profiles, and confirm the application of appropriate GMP. The Guidelines provide detail on factors to be used by MAHs for completing each of these steps.
To read more, download position paper