IPEC e-newsletter - Excipients Insight October 2018 - 31-10-18

 

Inside this issue

     

Editorial

Dear Excipients Insight readers,

Welcome to the latest edition of our newsletter.

As I think of what’s been happening in recent weeks, once more we are in a hurry to consider some draft guidance documents from the China Pharmacopoeia (ChP) Commission on excipients of animal origin and excipient suitability studies. These have been distributed to our IPEC Europe members and relevant committees, and as I’ve mentioned before we greatly appreciate your contributions in very short turnaround times. Increasingly, we present excipient perspectives to stakeholders through the IPEC Federation which accesses all IPEC worldwide to deliver a more global viewpoint. However, while harmonization is a goal, it is important to ensure that any unique regional requirements are considered. So we rely on you to help identify those critical matters for members operating in Europe and whose business interests extend to China. We are working with IPEC China to get better visibility of the ChP workplan to manage our responses better and the process being developed by our QRAC (Quality & regulatory Affairs Committee - see our article here) should facilitate improvements on how we do this. We will feature this new procedure in a future edition.

And so to the meeting the IPEC Federation held with the Pharmacopoeial Harmonisation Group (PDG) hosted by EDQM in Strasbourg on 3 October. Representatives included the European Pharmacopoeia, Japanese Pharmacopoeia and the United States Pharmacopeia. WHO participated as an Observer. Topics discussed included monographs on cellulosics, polyethylene glycol, pregelatinised starch and silicon dioxide. PDG reported on the success of its technical (video) conferences to accelerate their work programme but at this time, attendees at PDG will not be extended to include other world pharmacopoeias. So, IPEC will continue to develop its strategy at the Federation level which will aim to promote harmonisation to those emerging pharmacopoeias, such as China, which are extremely active and important in the global market. Very much "one to watch!"

And finally, I’d like to draw your attention to our next webinar ‘Using Risk Assessment to Define a GMP Strategy for Excipients’ to be held on 8 November. It’s hard to believe nearly two years have passed since our inaugural webinar which focussed on the ’how to’ of formalised risk assessments for the appropriate GMP for excipient. In our latest event, the emphasis will be on using risk assessment to identify GMP hazards offering a means to improve the quality management system within excipient manufacturers. Dr Iain Moore is the speaker, a true expert on this subject and we’ll be piloting some new interactive technology (for us!) to gather attendee inputs during the broadcast and better inform the dialogue. So, please join us!

Until next month, enjoy this edition.

 

Frithjof Holtz

IPEC Europe chair      

 

 

 

 

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