IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17

 

Inside this issue

     

Editorial

Dear readers,
 
Our October edition of Excipients Insight is rather a bumper one! There’s a lot happening not least in the European regulatory environment, with seemingly many new revisions of legislation and guidance related to medicinal products. We all know how hard it is to keep track of everything and we very much hope that the updates in this month’s publication help you with that goal. This leads me nicely to mention the survey you’ll find in this edition. It’s one of our objectives this year to see how we can make Excipients Insight better - does it meet your current needs? And what of the future? In which direction would you like to see our primary communication tool progress? I know I’m always asking things of you but I hope that you can find time to take this short survey. It will really help us to set some targets so I thank you in advance for sharing your thoughts and ideas with us.

But back to regulatory news. The EC and EMA have published Revised Labelling Guidelines for certain excipients so that’s a ‘must see’ for many members. So far only the annex has been revised, with the main text still to be updated. IPEC Europe has submitted comments on the revision and we will update the membership when there are further developments to report.  Meanwhile, there are other updates on GMP for commercial and investigatory products and also news of revisions to the Turkish GMPs, to align them more closely with PIC/S and so EU GMP requirements. Turkey has a robust inspection process in place and as one of the chapters updated in 7. Materials Management which includes the evaluation of suppliers, it could well result in more inspection focus on excipients, so take note!

There’s a lot to report on IPEC activities, too. With the APV/IPEC conference in Berlin, exhibiting and presenting at Powtech in Nuremberg, and IPEC Federation meetings with the Pharmacopoeia Discussion Group and China regulators, I think 2017 certainly represents an improvement in our collective outreach. We have to ‘speculate to accumulate’ and here’s hoping this translates into new members and very importantly, helps to achieve that part of our vision to promote and achieve worldwide acceptance and use of the IPEC developed guidelines. I would like to highlight the article on the longstanding certification process in Japan, namely the GMP Auditing Board for Pharmaceutical Excipients (GAB). Several members have asked for more information on this programme which will hopefully be of interest to many more. At Nuremberg, the IPEC Europe Board held its third face-to-face meeting this year which will be reported in the November edition. But from here on to the end of this year, we’re focusing on the next stage of our Agenda 2020 and the 2018 objectives to achieve that. So I leave you with another request, to revisit this document, and don’t hesitate to contribute any of your own views to develop the next stage of our journey!

 

Frithjof Holtz

Chair of IPEC Europe

 

 

 

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