Word of the Chair
Dear IPEC Europe members,
The April edition of our newsletter summarises some key developments and events related to excipients. Furthermore, I would like to inform you that the draft Risk Assessment Guidelines for excipient GMP - as published by the European Commission (EC) for consultation earlier this year - have now been reviewed by IPEC Europe and a response provided to the EC.
A similar process will also be carried out for the draft proposal of chapter 5 of EU GMP Guidelines Part I (Production) which contain a lot of new requirements related to qualification and control suppliers to pharmaceutical industries. We have reported on this in previous issues of Excipients Insight. Members will also get the opportunity to provide comments to this IPEC Europe response before submission to EC.
Together with IPEC Americas and the Pharmaceutical Quality Group (PQG) we started the process to update our GMP Guide for excipients which was published 2006. This will take some time but the developments in industry and regulation require modernisation of this “core document” of our association.
Responses to draft regulation and guidance documents for industry are important activities of our association. Whenever you are interested to contribute to one of those projects, do not hesitate to contact the IPEC Europe secretariat on anybody from the board. We would be very happy for your support.
Last but not least we are very happy about the development in EXCiPACT, our excipient certification project. Currently pilot audits are ongoing, the interest of certification bodies in the system is increasing and on 29 April EXCiPACT officially launched in the US during ExcipientFest in Baltimore.
Enjoy reading and best regards,
Chair of IPEC Europe