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

 

Inside this issue

     

Quality & Regulatory Affairs Committee (QRAC) update

Twelve Quality & Regulatory Affairs Committee  (QRAC) members met in Brussels on 28 September, with many more joining online, to review and progress the many initiatives under the responsibility of this group.  One of the tasks which was accomplished was to finalise a tracking tool for all on-going activities, identifying those projects which are active and others which only require monitoring at this stage. The grid will be posted on the committee’s site in the members’ area and will include those activities which are not directly managed by IPEC Europe’s QRAC but relate to its remit. An example would be ICHQ3D efforts on elemental impurities, which are led by a task force but one the QRAC’s team will keep actions and outcomes on its ‘radar’.

Of the main topics discussed, some time was devoted to sharing experiences related to the introduction of the so called, new Chinese Bundling Regulations for excipients and the findings of a recent survey. While the results of that poll will be published later, it is clear that it is early days for this new process and there are many questions as to the level of data which should be included in applications. The survey will be run periodically to build a picture of how implementation is going and it is hoped that this information will be useful in future discussions within IPEC and even with Chinese regulators themselves. As reported in a recent edition of Excipients Insights, the review of iron oxide E172, as a food additive being carried out by the Europe Food Safety Agency (EFSA. An industry-based consortium has been formed which will coordinate the generation of the requested safety data and as this may take two or more years, this is one subject which QRAC will monitor to determine if any actions might be required of IPEC Europe. The outputs of the recently formed working group on primary packaging materials for excipients were presented which should see the delivery of a position paper on how to address the various requirements for such components relative to the various regulations for chemicals, foods and pharmaceuticals, early in 2018. It’s always good to be able to inform members when an activity is completed and on this occasion, it was great to hear that the work to revise the IPEC Quality Agreement Guide is in its final stages. This now only needs approval at the IPEC Federation level, and it is anticipated that an official launch will take place in Q4 2017, accompanied by a webinar. Thanks to all contributors for their very hard work, and notably to Astrid Stockrahm for showing great determination to conclude this effort.

The other subjects discussed are listed in the agenda on the member’s site and the minutes of this and other QRAC meetings can be found there, too. But if you have any questions on any matter or want to suggest other areas of focus for QRAC, its chair, Johanna Eisele (pictured), is waiting to hear from you!

 

 

 

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