18 December 2014

The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2013 and now enters the implementation period (Step 5).

This new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The existing ICH Q3A Guideline classifies impurities as organic, inorganic, and residual solvents. The Q3A and Q3B Guidelines effectively address the requirements for organic impurities. An additional Guideline Q3C was developed to provide clarification of the requirements for residual solvents. The new Q3D Guideline would provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification.

The final Guideline is now available for download under the Quality Guideline page.