From The Corner Lab - Blog Posts

Elemental Impurities: Where we were then, Where we are now, and Where are we going

Posted by Jim Menoutis on Tue, Sep 22, 2015 @ 05:44 PM

EL-Sci_image

On Wednesday, September 9, 2015 the FDA published the final Q3D Elemental Impurities Guidance for Industry. At the same time, Contract Pharma Magazine published a feature article in its September issue on elemental impurities. The feature discusses elemental impurities in depth with perspectives on USP and regulatory the expectations from both FDA and EMA. The article notes that” …In both Europe and the US, the EQDM/EMA and FDA deadlines for compliance of new marketing authorization and new drug applications, respectively, with ICH Q3D are each set for June 2016…” to access the article in full click below:

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Topics: USP <232> USP <2332>, Elemental Impurities, USP <233> elemental Impurities, FDA, ICH