IPEC e-newsletter - Excipients Insight October 2016 - 31-10-16

 

Inside this issue

     

Editorial

Dear IPEC Europe members,

After months of preparation, I am delighted to announce that registration is now open for the IPEC Europe Annual Forum, which is a landmark event for our association as we will celebrate our 25th anniversary. I hope many of you will be able to join us in Monaco on 2 February to celebrate and keep abreast of new developments in the excipients world. 

The 2017 Forum will provide insights into evolving issues including China's bundling review regulation, harmonisation, continuous manufacturing, quality metrics and data integrity, and delegates will also hear about IPEC Europe's new guides and other ongoing projects.

As autumn gets into full swing we have seen with usual flurry of activity on the conference track, including events such as CPhI in Barcelona and the APV/IPEC Europe conference,  as well as regulator-led forums such as the EDQM's recent event in Tallinn and the WHO's annual Expert Committee on Specifications for Pharmaceutical Preparations. Of particular note is that EDQM and the China Pharmacopoeia held a stakeholder workshop in Strasbourg to explore the current trends and hot topics in the 10th Edition of the Chinese Pharmacopoeia and the 9th Edition of the European Pharmacopoeia. It’s good to see so much transparency and IPEC Europe continues to fulfil its mission to maintain its public profile and represent excipients at meeting such as these.
 
Reports on these important events are provided in this or in a future edition of Excipients Insight, but I wanted to highlight one item which always seems to feature on the agenda - the subject of harmonisation. Whether it’s related to pharmacopoeial standards or expectations for their supply, it’s a subject that remains as relevant as ever. As a feature in this month’s edition explains, maintaining compliance for non-harmonised materials becomes increasingly complex in today’s world of global supply chains. As China extends its international reach, its pharmacopoeia grows in importance. As we heard in Strasbourg, the 2020 edition is already in the planning stages, and will include another 100+ new excipient monographs. So it’s easy to see that IPEC has a role to play in supporting harmonisation efforts wherever we can. For example, it’s a must to encourage the use of Good Pharmacopoeial Practices to drive consistency and harmonisation and not divergence in excipient monographs and methods. But with all of these efforts, we must always bear in mind that that overrising objective is to ensure high quality medicines are available for patients.

As IPEC Europe heads towards our 25th anniversary in 2017, it is good to remember that the pivotal reason for our creation was the harmonisation of pharmacopoeial standards for pharmaceutical excipients.
 
Frank Milek
IPEC Europe, President
 

 

 

 

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