FDA Invites Comment on New Exposure Limits for Cadmium
FDA has issued a call for comments on a proposed change to the International Council for Harmonization (ICH) Q3D Elemental Impurities guidance document that corrects a calculation error in the permissible daily exposure (PDE) for cadmium by the inhalation route of exposure.
ICH Q3D Elemental Impurities
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 The draft guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure.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FDA issued a draft guidance document on July 13, 2018, inviting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
ICH Q3D Quality guideline on Elemental Impurities
last time modified: July 31, 2018