IPEC e-newsletter - Excipients Insight October 2018 - 31-10-18


Inside this issue


QRAC covers master files, packaging and more at September meeting

The most recent meeting of IPEC Europe’s Quality & regulatory Affairs Committee (QRAC) core team was a teleconference on 26 September, which involved bringing several initiatives closer to conclusion. These include documents presenting positions on excipient master files, primary packaging materials for excipients and the QRAC process for the review of new or modified regulations. Much effort has been spent lately on new requirements in China and also, the impact of the latest regulations in Vietnam on excipients is under consideration.

Also, the committee agreed to encourage members to complete the survey issued by the USP based on its Stimuli article “Complexity of Setting Compendial Specifications for Excipient Composition and Impurities”  which can be accessed via this link: https://uspta.qualtrics.com/jfe/form/SV_estdZM9mb8CVvN3

The next committee meeting will be held in Brussels on 28 November where time will be devoted to getting the collective input of QRAC members on several 2018 initiatives and to intitiate the 2019 work plan.




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