IPEC e-newsletter - Excipients Insight December 2017 - 18-12-17


Inside this issue


Quality and Regulatory Affairs Committee (QRAC) meets in Darmstadt

On 16 November, the IPEC Europe Quality & Regulatory Affairs Committee (QRAC) was hosted by Evonik GmbH at their facilities in Darmstadt, Germany. This was the fourth meeting of 2017 and the agenda covered a range of topics which included a significant discussion on PharmaEuropa’s second draft of its monograph on co-processed excipients. All comments are being complied, including those from sister associations, for submission back to EDQM before the end of this year.

Attendees (both physically present and online) welcomed an update on the changes to the EXCiPACT standard, the new version of which is available for download here. A topic which features regularly at QRAC meetings is elemental impurities, with one perennial point of discussion being that the USP approach to replacing classic ‘heavy metals’ testing differs from EDQM. USP has been collaborating with IPEC-Americas to request test data from the excipients community to help establish test parameters which USP feels are appropriate for excipients. The instructions on how members can submit their data if any company wishes to participate is available from the IPEC Europe Secretariat.

Another request for collaboration was shared with the team, namely that the Chinese Pharmacopoeia (ChP) is encouraging companies to provide samples and data to support their excipient monograph development and review programme. Also, ChP proposals for excipient nomenclature which are being circulated for comment across the membership, were discussed. The most significant issue is that if ChP introduces a practice for nomenclature based on specific routes of administration, this could create major disharmonization with other global pharmacopeias. Trade issues may also arise for global excipients imported into China.

Plans were fixed to deliver a position paper on primary packaging materials for excipients in the near term, and the group conveyed a strong preference that QRAC initiates a project in 2018 to develop a full guide on this subject. With the imminent launch of the Quality Agreement Guide the working group was formally disbanded and great thanks were expressed to Astrid Stockrahm-Uhling and her colleagues for their tremendous efforts. Astrid will now take the lead for IPEC Europe with the next version of the IPEC-PQG GMP Guide.

Some new topics were brought to the table, including a growing trend for statements on the gluten-free status of medicines and recent ICH discussions on sunscreens and elemental impurities. Finally, the group held a short thought shower to discuss 2017 achievements and 2018 objectives which will be presented at the next meeting in Bordeaux, as part of IPEC Europe annual event.




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