IPEC e-newsletter - Excipients Insight August 2017 - 11-08-17

 

Inside this issue

     

Editorial

Dear colleagues,

Here’s our mid-summer offering of Excipients Insight - and here's hoping it manages to reach you, as no doubt many will be away from your offices enjoying a well-deserved break on sun-kissed beaches! Nevertheless, in our world of excipients, there are still matters of interest to share with you so please enjoy this month’s contributions.

For August, we have two features of note from IPEC Europe ‘champions’, Kate Denton and Andy Teasdale. Both are extremely active in important areas for us and the articles included here provide informative updates on excipients and ‘high-tech’ biological products and a subject which likely needs no introduction, ICH Q3D requirements for elemental impurities in excipients. We think this is a good way to keep you aware of developments, where you hear directly from experts in these fields on the current state-of-play on key subjects. If you feel there are other topics which would benefit from this approach or you, yourself feel you’d like to be involved in an article, please don’t hesitate to get in touch with us.

The pieces themselves contain some thought-provoking issues. For example, the highly proprietary and innovate nature of novel excipients require not only systems to protect confidential data but also to promote their use to support therapeutic advances. It begs the question though, when would be the right time to discuss these matters to help deliver greater benefit to patients? As currently, these processes are not part of the EU regulatory framework, is a DMF system necessary? Do we need an independent review process to encourage the use of novel excipients without fear of regulatory barriers? Let us know what you think!

And while it’s great to hear that the ICH Q3D requirements are not revealing many significant issues thus far, national and regional pharmacopoeias seem to be adopting divergent approaches in managing the removal of residual heavy metals test from individual excipient monographs. IPEC Europe has expressed its support of the approach adopted by EDQM, to remove specific elemental impurities tests for monographs with the understanding that there is no evidence of patient safety risk by doing so. Once again though, this serves to remind us that harmonisation as one of the original pretexts for the creation of IPEC, is still relevant and there is still a need to have it on our agenda. The IPEC Federation will have its annual meeting with the Pharmacopoeial Discussion Group at the USP headquarters in Rockville, on 13 September where IPEC Europe representatives will attend and harmonisation matters will be discussed.

And finally, it gives me great pleasure to welcome Ilias Grampas, to the IPEC Europe Secretariat team. As part of an internship programme, Ilias will be with us for six month and while September’s edition will include a full profile of his role, I wanted to introduce you to him now as he came on board on the end of July. I am sure you will join me in wishing him a full and rewarding assignment with IPEC Europe.

Happy holiday reading!

 

Frithjof Holtz

Chair of IPEC Europe

 

 

 

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