Elemental Impurities ICH Q3D: Data and reality

The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a challenge for the pharmaceutical industry. Based on the document ‘Implementation strategy of ICH Q3D guideline’ (EMA/CHMP/QWP/115498/2017 – Committee for Medicinal Products for Human use (CHMP), there are two different approaches to risk management of elemental impurities…