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FDA Invites Comment on New Exposure Limits for Cadmium


ICH Q3D Elemental Impurities is a quality guideline for the control of metal impurities in drug substances and drug products. The guideline establishes PDEs for 24 elemental impurities for drug products administered by the oral, parenteral, and inhalation routes and offers guidance on how to develop an acceptable level for elemental impurities for drug products administered by other routes of administration.

Revised Q3D Elemental Impurities guidance document:

The ICH Q3D Expert Working Group issued in May 2018 a revised calculation in the document Q3D(R1). The draft guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure. The updated PDE of 3 micrograms (μg)/day is based on a modifying factor approach that is consistent with the oral and parenteral PDE calculations. 

FDA issued a draft guidance document on July 13, 2018, inviting comments on the proposed changes as part of global regulatory policy harmonization efforts. Comments are due on August 13, 2018.

Source: Federal Register

Related information

ICH Q3D Quality guideline on Elemental Impurities

last time modified: July 31, 2018


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