IPEC e-newsletter - Excipients Insight February 2013 - 28-02-13

 

Inside this issue

     

Word of the Chair

Dear IPEC Europe members,

A lot happened in our "excipient world" early this year which you will find in the current issue of our Excipients Insight newsletter.

Among the key developments on the regulatory front, the EU Commission has published public consultations on draft risk assessment guidance for excipient GMP and on new supplier qualification requirements in chapter 5 of EU GMP Guidelines Part I. IPEC Europe will surely respond to these regulatory proposals. If you are interested to contribute please contact us. We also summarise some key developments in China and the US in this edition.

In late January our IPEC Europe seminar and annual general meeting held in Cannes were very successful events with more than 120 participants. If you were unable to attend the seminar or simply need a reminder of the topics covered you can read our report here.

We also want to inform you that the new revision of the IPEC CoA Guide has been published and is available on our website for download. Last but not least, our priority project EXCiPACT moves forward, with pilot audits started already in Europe and the launch in the US tobe celebrated in April in Baltimore.

A lot of information has been collated for you. So, enjoy reading.

Kind regards

Frank Milek

Chair to IPEC Europe

 

 

 

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