The ICH Q3D Guideline was finalised under Step 4 in November 2014. It is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration. In addition, guidance is provided in ICH Q3D on how to develop an acceptable level for EIs for drug products administered by other routes of administration.

The Q3D(R1) and Q3D(R2) Guidelines reached Step 4 of the ICH process in March 2019 and April 2022, respectively.

Maintenance Process
A maintenance procedure for the Q3D Guideline was set up to enable incorporation of Permitted Daily Exposure (PDE) for new elemental impurities (EI)/routes of administration and revising the PDE for EI as new toxicological data for EI becomes available.