Q3D(R2)-Guideline for Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Q3D(R2) Guideline for Elemental Impurities." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance revises the guidance for industry "Q3D(R1) Elemental Impurities" issued in March 2020 to provide Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration. It also provides relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. The guidance is intended to provide recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products and for conducting risk assessments.