IPEC e-newsletter - Excipients Insight April 2015 - 30-04-15

 

Inside this issue

     

Word of the Chair

Dear IPEC Europe members,

Last month, the European Commission published the final version of the EU Risk Assessment Guide for excipient GMP (see our article here). This is an important piece of regulation which will keep our association busy in the coming months. Very soon we will publish a position paper to address important topics related to this EU guide and its implementation, and IPEC Europe will continue to work on implementation of risk management principles in the supply chain of excipients.

We have formed a taskforce that will start work soon on related matters, and have also set up a taskforce for the revision of the IPEC PQG GMP Guide 2006 - another important project for our association - together with PQG and IPEC Americas. You can find details about these topics in this edition of our newsletter. Furthermore, you find in this issue more information about activities out of the framework of our collaboration with other IPECs, such as the new ANSI/IPEC/NSF 363 standard and the IPEC Federation glossary of terms. Please consider also the call for volunteers for a taskforce to work on the ICH Q3D implementation.

We are currently preparing this year’s IPEC/APV Excipient Conference in Barcelona on 23-24 September 2015. Find the current program in this newsletter. We think the program provides a very good mix of regulatory and technical topics around excipients, and the board would be delighted to welcome you to this event.

Enjoy reading and kind regards

Frank Milek

Chair of IPEC Europe

 

 

 

Copyright © 2005 - 2009 IPEC Europe - International Pharmaceutical Excipients Council