IPEC is the industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with our counterparts in Europe, China and Japan serves as primary international resource on excipients for its members, governments and public audiences. more>
ICH Q3D Guideline for Elemental Impurities will be effective June 2016. Learn from the excipient experts how this will impact your company as a maker or user.
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.