An NSF International Company ICH Q3D - Elemental Impurities
Thursday the 8th August 2013
The ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in July 2013 and entered the consultation period (Step 3). The regulatory authorities in the ICH regions of the EU, Japan and the USA will now publish it for consultation.
This new Guideline is proposed 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 and Q3C provides clarification of the requirements for residual solvents.
The proposed new Guideline Q3D will provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification.
Elemental impurities in medicinal products may come from a variety of sources including those added during chemical synthesis, the presence of elemental impurities in raw materials, or those that result from contact with processing equipment. This guideline identifies elemental impurities that may have potential health/toxicology impact, establishes Permitted Daily Exposure (PDE) of those impurities and addresses controls necessary to maintain the impurities below the recommended PDE.
