IPEC e-newsletter - Excipients Insight February 2018 - 28-02-18


Inside this issue


Busy times ahead for Q&RA Committee

The Quality & Regulatory Affairs Committee covered a lot of ground in 2017, completing and publishing the new version of the IPEC Quality Agreement guide, forming task forces on continuous verification, China’s bundling process for excipients (now defunct) and newer regulatory developments, and requirements for primary packaging materials. It also contributed to the revisions of the IPEC-Americas phase 1 risk assessment guide as well as its work on the FDA’s Critical Path Initiative.

Speaking at the IPEC Europe annual general meeting in Bordeaux, Committee chair Johanna Eisele (pictured) also highlighted the work done in preparing and submitting comments to the European Pharmacopoeia (Ph. Eur.) on the draft monograph on co-processed excipients, working with IPEC-Americas in a coalition on atypical actives and monitoring the new requirements for elemental impurity testing.

2018 is also shaping up to be a busy year as the work on primary packaging materials and the continuous verification guide continues along with new projects – including revisiting the objective of an excipient master file (EMF) in Europe, the revision of the Excipient Information Package guide, a project with IPEC-Americas to develop a ‘how to’ document to accompany the revised IPEC PQG GMP guide. The Committee also intends to keep a close eye on regulatory developments including the new EFSA draft guidance on risk assessment on nanoparticles in food (see our article here).




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