IPEC e-newsletter - Excipients Insight September 2016 - 30-09-16

 

Inside this issue

     

Q&RA committee update

IPEC Europe's Quality & Regulatory Affairs (Q&RA) committee held its latest meeting in Brussels earlier this month, discussing a range of topics including the evolving 'bundling review' regulations in China, which were discussed in the August edition of this newsletter.

Several questions were raised in response to the regulations, which will be addressed to IPEC China. There will also be an opportunity to discuss the evolving regulatory environment in China at the forthcoming workshop between the European Directorate on the Quality of Medicines and Healthcare (EDQM) and the Chinese Pharmacopoeia (ChP), which will be held in Strasbourg on 17 October.

The committee also discussed progress with the revisions to two important guides - the 2009 IPEC Quality Agreement and Template and Joint IPEC-PQG GMP guide - which are in the final stages of development and are scheduled for publication in early 2017.

 

 

 

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