FDA Releases Draft ICH Guidance Revision on Elemental Impurities

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry that was prepared by the International Council for Harmonisation (ICH) on elemental impurities.

The 7-page guidance, entitled “Q3D(R1) Elemental Impurities,” revises the existing ICH guidance for industry “Q3D Elemental Impurities” and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure.

“The updated PDE of 3 micrograms (µg)/day is based on a modifying factor approach like that used for calculating the PDEs for the cadmium oral and parenteral routes of exposure. The draft guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure,” FDA said. “Following deliberations within the Q3D Expert Working Group, the revised calculation is based on a modifying factor approach that is consistent with the oral and parenteral PDE calculations.”

In May 2018, the ICH Assembly endorsed the draft and agreed that the guideline should be made available for public comment.

The draft is the product of the Quality Expert Working Group of the ICH, and comments will be considered by FDA and the Quality Expert Working Group.