Clarification for products outside the scope of the ICH Q3D Guideline

A new guidance document has been released: “Ph. Eur. Policy on Elemental Impurities: Clarification for products outside the scope of the ICH Q3D Guideline.”

The European Pharmacopoeia Commission published its implementation strategy for the International Conference on Harmonization’s Q3D guideline for elemental impurities, in a press release dated 28th April 2015. The European Pharmacopoeia Commission decided to reproduce verbatim the ICH Q3D guideline in the Ph. Eur. chapter 5.20. For products outside the scope of the ICH Q3D guideline such as products for veterinary use, the absence of elemental impurities (incl. heavy metals) tests from an individual monograph on a substance used for their production does not release manufacturers from the need to control the level of such elements in their products, where relevant.

For further details see: Ph. Eur.



 Posted by Tim Sandle