GMP: FDA issues new Draft Guidance on Elemental Impurities

The ICH Q3D \"Guideline for Elemental Impurities\" was issued in December 2014 and recommended for adoption in the regulations portfolio of the ICH regions Europe, USA and Japan according to the ICH step-by-step procedure (Step 5). With the publication of the \"ICH guideline Q3D on elemental impurities\" (EMA/CHMP/ICH/353369/2013) in August 2015 the European Medicines Agency (EMA) implemented this step and determined June 2016 (for medicinal products to be newly approved) and December 2017 (for already approved medicinal products) as the dates for the Guideline to come into effect. The FDA took over the ICH Q3D Guideline in September 2015.

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