13 July 2022

Introductory training on ICH Q3D(R2) Guideline for Elemental Impurities

ICH Q3D(R2) Maintenance Expert Working Group (EWG) has developed an introductory training material that is available on the Q3D(R2) webpage (presentation and training material). ICH Harmonised guideline Q3D(R2) Guideline for elemental impurities is a quality guideline for the control of elemental impurities in new drug products, and it establishes Permitted Daily Exposures ( PDE’s) for 24 Elemental Impurities (EI’s) for drug products administered by the oral, parenteral and inhalation routes of administration. In addition, guidance is provided on how to develop an acceptable level for EIs for drug products administered by other routes of administration. The current Q3D(R2) Guideline reached Step 4 on 26th of April 2022, and included a correction of PDE’s for gold, silver and nickel, Gold and Silver monographs and an addition of limits for elemental impurities by the cutaneous and transcutaneous route.