Arlington, Virginia (06-Nov-2017)
PRESS RELEASE download
IPEC-Americas and IPEC Europe Publish Risk Assessment Guide for Excipient Makers, Users, and Distributors.
IPEC-Americas and IPEC Europe have jointly published the Co-processed Excipient Guide for excipient makers and users. The new guide offers best practices toward co-processed excipient development, manufacture and use, and provides support to both co-processed excipient manufacturers and users.
A co-processed excipient is a combination of two or more compendial or non-compendial excipients designed to physically modify their properties in a manner not achievable by simple physical mixing, and without significant chemical change.
Co-processed excipient users are responsible for assuring fitness for purpose and that the co-processed excipient and its components are manufactured to acceptable good manufacturing practice (GMP) standards. The guide facilitates communication between excipient users and suppliers regarding the safety information required for regulatory filing for a product containing a novel co-processed excipient.
The Guide is available for download at no charge to IPEC-Americas members and non-members (after registering or logging in with existing account) by visiting the Document Depot (under Resources - IPEC Guides).
IPEC-Americas will provide a webinar (FREE for members, $59 for non-members) on December 15, 2017 from 11:00 am – 12:00 pm EST to review and answer questions on the guide. For more information about the webinar, and to register, click here.
IPEC-Americas 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 its counterparts in Europe, China, Japan, and India serves as a primary international resource on excipients for its members, governments, and public audiences.
Initially created in 1992, IPEC Europe, the International Pharmaceutical Excipients Council Europe is not-for-profit European association registered in Belgium bringing together producers, distributors and users of pharmaceutical excipients.