News about GMP/cGMP

29.03.2019

ICH: New Inhalation-PDE for Cadmium in Q3D-Guideline

On 22 March 2019, ICH published the final revision of the Guideline for Elemental Impurities Q3D (R1). The reason for the revision is an adjustment of the PDE value for cadmium by inhalation.

Cadmium is now listed with a new inhalation PDE value of 3.4 µg/day. The original value published in 2014 was 1.7 µg/day. It did not agree with the oral and parenteral PDE calculations, which are also given. Obviously, a modifying factor was not taken into account. Following a public consultation in May 2018, the value was revised and corrected.

The Quality Guideline ICH Q3D for the control of Elemental Impurities in medicinal products defines the Permitted Daily Exposure (PDE) for a total of 24 metallic impurities. For the new version of ICH Q3D please click here.


Source:

ICH: News



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