IPEC e-newsletter - Excipients Insight November 2017 - 22-11-17


Inside this issue



Welcome to Excipients Insight November 2017.

As this is the penultimate edition of our newsletter in 2017, it’s nice to be able to share with you here the outcomes of much hard work on your part and of course, our sister organisations. The introduction of the Quality Agreement and Co-Processed Excipients Guides really contribute to our mission of spreading the word on current excipient issues to assist you in your compliance and business efforts. And this is just the tip of the iceberg as to what’s in line for 2018. We have to keep our guides current and relevant, so plans are being developed to improve GMP, GDP Audit and Excipient Information Package Guides at the IPEC Federation level. Excuse me for repeating this, but I don’t think I can ever say it enough … please contact us if you’re interested in participating in any of these teams! And for those who have been involved already, thanks again to you and your companies for the vital resources that enables us to do all of this great work.

To complement the introduction of the Quality Agreements Guide you can read here about our accompanying webinar. It’s a great opportunity to hear first-hand from a true expert, how good quality documents of this kind can make a difference. And I’d like to mention also that the issue of the Co-processed Excipients handbook is very timely. The second draft of Pharmeuropa’s monograph for these types of materials is out for consultation. We’re currently compiling comments from our member so if you missed out when it was distributed initially and think you’d like to express your thoughts on it, please get in touch with the Secretariat for more details.

This edition presents IPEC Europe’s first infographic, to add to our toolbox to reach out to the broader community involved with or to those who need to know more about excipients. As the article says, this is a ’first’ for us so we’d love to get your feedback on how successful we’ve been in getting the message across, particularly from any colleagues who may not be so familiar with excipients as yourselves.

And finally, one more plea if I may. Recently we have shared across the membership requests from both the pharmacopoeias of China and US for companies to submit data to help them with their monograph development work plans (for new monographs and elemental impurities respectively.) While this does require effort on your company’s part, ultimately it should lead to the establishment of better quality monographs, better representing global supply which ultimately, better for patients. So please consider participating in such programmes.

In the next issue, we’ll have reports from our committees and also the Board which holds its final meeting for this year on 28 November … if you have any issues which you’d like to raise with us, we’re happy to hear from you!

Meanwhile, pleasant reading!


Frithjof Holtz

IPEC Europe chair




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