ICH Guideline for Elemental Impurities Moves to Step 2b

The International Conference on Harmonization (ICH) reports that the ICH Q3D Impurities: Guideline for Elemental Impurities reached Step 2b of the ICH process in July 2013 and now enters the consultation period (i.e., Step 3). The formal ICH procedure consists of five steps: Step 1 Consensus Building; Step 2 Confirmation of Six-Party Consensus; Step 3 Regulatory Consultation and Discussion; Step 4 Adoption of an ICH Harmonized Tripartite Guideline; and Step 5 Implementation.

The proposed new guideline provides 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 address the requirements for organic impurities. An additional ICH guideline, Q3C, was developed to provide clarification of the requirements for residual solvents. The proposed new guideline, ICH Q3D would provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification.

Comments on the draft guideline may be submitted to the ICH Secretariat. Stakeholders from the European Union, the United States, and Japan are encouraged to submit their comments to their respective regulatory authorities.

Sources

ICH, “ICH Q3D Guideline Reaches Step 2b of the ICH Process,” Press Release, Aug. 5,  2013.

ICH, Q3D Impurities: Guideline for Elemental Impurities, Step 2b version, July 26, 2013.