22 March 2019

The ICH Q3D(R1) Guideline for Elemental Impurities reached Step 4 of the ICH Process in March 2019 and now enters into the implementation period (Step 5).

The ICH Q3D Guideline for Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration. The Q3D(R1) Guideline is the result of a revision of the PDE level for Cadmium by inhalation in the Q3D Guideline.

The ICH Q3D(R1) Guideline is available for download on the ICH website here.