IPEC e-newsletter - Excipients Insight November/December 2012 - 21-12-12


Inside this issue


Word of the Chair

Dear IPEC Europe members,

2012 has been packed with developments related to pharmaceutical excipients and IPEC Europe has been busy following and contributing to all the topics. There have been regulatory changes and proposals for new regulation which kept us busy, notably the implementation of the Falsified Medicines Directive (2011/62/EU) and its future impact on excipient suppliers and users as well as new regulatory proposals for excipients in China and Brazil. In the pharmacopoeia area we had to face the implementation of general chapters on metal impurities by USP and their conflict with other related regulation in the same area, such as the intended ICH Q3D Guideline. Many other developments have been followed and worked on by our committees and in all cases IPEC Europe has participated in industry responses and communication with regulators and other stakeholders.

Furthermore, the association has been active in EXCiPACT, our core project to contribute to future qualification and certification of the excipient supply chain. In this project we reached a major milestone in 2012 by signing contracts with the first two certification bodies, enabling us to start pilot audits of excipient suppliers in the first quarter of 2013.

Our involvement in the activities of our umbrella association IPEC Federation was characterised by joint meetings and contribution to regulatory responses by IPEC Federation and presentations during ExcipientFest 2012 in Beijing. IPEC Federation is now comprised by IPEC Americas, IPEC Europe, IPEC Japan, IPEC China and we will hopefully be enlarged by IPEC India soon.

We also organised the 2nd European Conference on Pharmaceutical Excipients in Berlin together with APV (see our article in this edition) which has been a great success and an opportunity to highlight the invaluable work carried out by IPEC Europe.

All these activities needed a lot of volunteers and their contribution. On behalf of the IPEC Europe board I thank all of you who contributed with your enthusiasm and drive in 2012 to keep our association lively and at the top of the excipient related developments around us. Our special thanks goes to the chairs and members of our committees and task forces. I hope to see all of you during our seminar and general meeting in Cannes late January.

On behalf of the IPEC Europe board I wish all of you and your families Merry Christmas and a Healthy Year 2013!

Kind regards

Frank Milek

Chair of IPEC Europe




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