From The Corner Lab - Blog Posts

ICH Issues Q3D step 2b Elemental Impurities Guideline; USP & EMA Take Action

Posted by Jim Menoutis on Wed, Aug 28, 2013 @ 05:17 PM

The International Conference on Harmonization (ICH) has started the consultation period on elemental impurities. ICH Q3D - Impurities: Guideline for Elemental Impurities - laying out limits for metallic impurities in pharmaceutical ingredients and preparations and detailing the testing procedures used to detect and measure them.  With the July 26, 2013 issuance of the guideline, Q3D has now entered step 2b of a five-step implementation process. There is a six-month comment period which gives  the industry and other stakeholders time to forward their comments.

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Topics: Elemental Impurities, CHMP, USP <232>, USP <233> elemental Impurities, FDA, ICH, Q3D, EMA