This ICH guideline has been revised from R1 to R2 to provide guidance on how to develop an acceptable level for elemental impurities for drug products administered by other routes of administration including cutaneous and transcutaneous routes of administration via the addition of Appendix 5 in section 3.2. A presentation has also been released by ICH detailing the new appendix.
This new Appendix to the Q3D Guideline applies to cutaneous and transcutaneous drug products whether intended for local or systemic effect. This Appendix does not apply to drug products intended for mucosal administration (oral, nasal, vaginal), topical ophthalmic, rectal, or subcutaneous and subdermal routes of administration. Products not covered by this Appendix should be evaluated in accordance with the approach discussed in section 3.2 of the main text of the Q3D Guideline.
The guideline was originally established as 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.
As a reminder, ICH Q3D is acceptable method for demonstrating the requirements for heavy metals for both DINs and NHPs.
