IPEC e-newsletter - Excipients Insight June 2018 - 19-06-18

 

Inside this issue

     

IPEC Europe flies the flag at Making Pharma

IPEC Europe was present at two back-to-back Making Pharma events in the last few weeks – an inaugural event in Brussels, Belgium, and the established exhibition and conference in Coventry, UK – which provided a great opportunity to give the association’s perspective on three important topics.

The presentations across the two events provided an opportunity to make use of IPEC Europe’s new informative video to introduce the association, while IPEC Europe representatives Astrid Stockrahm-Uhling of DFE Pharma, Iain Moore of Croda International, Liz Meehan of AstraZeneca and Christian Becker of BASF gave presentations covering the new Quality Agreement Guide and templates, excipient functionality-related characteristics (FRCs), and novel excipients.

The audience was engaged and inquisitive at both events, with plenty of questions during the sessions and follow-up at IPEC Europe’s stand.

Tackling the topic of excipient FRCs Meehan told delegates that excipients are increasingly being recognised for the critical role they play in pharmaceutical products and – far from being ‘inactive’ - all have functionality that can impact manufacturability, bioavailability, stability and sterility, for example. For some that functionality is more critical than others, and in general there is an increased focus on excipient functionality with regard to technical, regulatory and quality perspectives.

“Understanding excipient functionality is important during drug product design and development, presenting regulatory control strategies and ensuring appropriate GMP for excipients,” she told delegates. “Success relies heavily on close collaboration between excipient suppliers and users, a core philosophy of IPEC Europe.”

At the Brussels conference, Stockrahm-Uhling introduced the new IPEC Federation Quality Agreement Guide and Templates, published last year to replace the earlier 2009 editions, while Moore took on that role at the event in Coventry.

Both explained that the purpose is to set out all the quality management system requirements that must be met by either the supplier or customer to ensure the listed excipient is manufactured “in conformance with regulatory requirements or customer expectations.”

The templates are there to detail the quality activities and responsibilities that should be included in a Quality Agreement that is appropriate for excipients, they said. A good agreement should define all the quality requirements, define which party is responsible for them and detail how any disputes are to be resolved.

“The intent of this (Quality Agreement) is not to ‘rewrite’ GMP requirements,” they stressed.

Finally, Becker took on the topic of novel excipients. He explained that there is a need for new excipients that can help formulate an increasing number of poorly-soluble or permeable active pharmaceutical ingredients (APIs), facilitate new formulation technologies and improve drug stability in hot climates, as well as solve specific functions such as taste-masking to improve compliance.

Becker described the paths available to developers trying to bring novel excipients to market, which in Europe are limited to submitting data on the excipient as part of the marketing authorization holder (MAH) submission for a pharmaceutical product. He pointed out that unlike the US and Japan, Europe lacks a master file system open to excipients. IPEC Europe is continuously advocating the need for an excipient master file system for the EU as this would allow confidential CMC details to be submitted directly to the regulatory authority, rather than to “a possibly large number of applicants for inclusion into the MAH dossier.

Summing up the events. Moore told Excipients Insight that “in my opinion Making Pharma is a great showcase for IPEC Europe activities. There does seem to be more excipient suppliers and users at the event each year.”

That view was also shared by Meehan. “The UK event showed clear evidence that there are increasing numbers of exhibitors with an interest in excipients, both suppliers and users, and it is hoped that the Europe event will follow with that level of success in future,” she said.

 

 

 

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