This paper describes the position of IPEC-Americas on implementation of the NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.
The Coalition for Rational Implementation of the USP Elemental Impurities Requirements provided comments to USP which are related to the sample preparation methods in USP General Chapter <233>.
Several countries are requiring excipient suppliers to supply Certificates before they will allow the excipients to be imported into the country.
The Journal of Excipients and Food Chemicals, an IPEC-Americas published and sponsored Journal, is a open-access, online-only, peer-reviewed Journal that offers a unique forum for th
IPEC Federation Position Paper Press Release on Metal Impurities in Excipients
On December 9th, 2011 a team of five IPEC-Americas representatives met with about 20 representatives from the US FDA to discuss the Inactive Ingredients Database (IID).