On December 2017, the ICH Q3D Guideline on Elemental Impurities will come into effect for already approved medicinal products. From June 2016 this requirement is already in force for new marketing authorization applications. Three parts of this guideline are detailed: the evaluation of the toxicity data for potential elemental impurities; the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern; and application of a risk-based approach to control elemental impurities in drug products. If the total elemental impurity level from all sources in the drug product is expected to be consistently less than 30% of the PDE, then additional controls are not required, provided that the applicant has appropiately assessed the data and demonstrated adequate controls on elemental impurities.
