IPEC e-newsletter - Excipients Insight November 2017 - 22-11-17

 

Inside this issue

     

IPEC-Americas and IPEC Europe publish Co-Processed Excipient Guide

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 on the IPEC Europe website at www.ipec-europe.org or for IPEC-Americas members and non-members by visiting www.ipecamericas.org (after registering).

A free webinar that highlights guide content will be hosted by IPEC-Americas on Friday, December 15, 2017 from 11:00 am – 12:00 pm EST. For more information about the webinar, click here: http://ipecamericas.org/excipient-learning-lab/webinars/co-processed-excipient-guide-overview

 

 

 

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