International Conference on Harmonisation; Guidance on Q3D Elemental Impurities; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q3D Elemental Impurities.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance establishes permitted daily exposures for 24 elements in drug products based on evaluation of toxicity data. Permitted daily exposures are provided for each element by three routes of administration--oral, parenteral and inhalation. The guidance also provides for a risk-based approach to assessing the likelihood that elemental impurities with established permitted daily exposures will be present in a pharmaceutical product. The guidance is intended to provide a harmonized approach to control of elemental impurities in pharmaceutical products in order to avoid the uncertainty and duplication of work that results from different requirements in different ICH regions.