IPEC e-newsletter - Excipients Insight March 2017 - 31-03-17

 

Inside this issue

     

Editorial

Dear colleagues,

Spring is upon us and as ever there is a lot of activity on-going, both within IPEC and the excipient world in general. At the beginning of April, the IPEC Europe Board will meet in Brussels and we will make our first review of the objectives which were presented at our recent Annual General Meeting in Monte Carlo. As ever, we have established ambitious targets to help us move towards our 2020 Agenda goals and in the next edition we’ll provide an update on the more significant steps which have been taken, both within IPEC Europe and those which relate to the IPEC Federation. We always like to hear from you our members, and if you think there is something the Board needs to be discussing, please feel free to let us know soonest through our Secretariat.

In the external environment, this month’s edition provides some interesting features on the regulatory world, not least the draft excipient labelling guidelines issued by the European Commission. It is important that IPEC Europe responds to all excipient-related legislation and so we have distributed this across our membership. While we know member companies may submit their comments directly, in IPEC’s own feedback, we like to represent the breadth and diversity of our association so I would urge you to send your comments back to us. It also allows us to emphasise those points which have the greatest impact on our industry as you, the members see it. Likewise, revised EXCiPACT standards used for excipient supplier certification are open for comment, to align them with ISO / ISE where your feedback will be invaluable.   We look forward to hearing from you!

We hope you find the articles on Certificates of Analysis and Supplier Qualification of interest, too. It is good to note that we believe the IPEC Guidance on CoAs is aligned with the applicable EU regulatory requirements, another example of the value of IPEC Guides and why it is worth investing in them. The summary on supplier qualification regulations also reminds us that a common understanding across the excipient supply chain can help compliance and to forge good customer relations. And as I’m sure we'll see the themes outlined in the US FDA data integrity inspection deficiencies article echoed many times this year and beyond. This is an area focus for the IPEC Federation as it attempts to provide some context for excipient suppliers, which we will report on in Excipients Insight soon.  

Meanwhile, enjoy this issue!

Frank Milek


Chair of IPEC Europe

 

 

 

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