News about GMP/cGMP

08.06.2018

ICH Q3D: Public Consultation on Cadmium Inhalation PDE Level

The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period. The revision is focused on an error correction in the calculation of the Cadmium inhalation Permitted Daily Exposure (PDE) level.

The Expert Working Group re-evaluated the data supporting the Cadmium inhalation PDE and concluded that a modifying factors approach, similar to that used for calculating the oral and parenteral PDEs, was appropriate for the inhalation PDE. The corrected value resulted in 3.4 μg/day.

Cadmium (Cd)
	Oral	Parenteral	Inhalation
PDE (μg/day)	5.0	1.7	3.4

Comments on the ICH Q3D(R1) draft revision document can be entered by e-mail to the ICH Secretariat. More details can be found under the Public Consultation page.