ICH Guideline for Elemental Impurities Moves to Step 2b - A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredie

ADVERTISEMENT

ICH Guideline for Elemental Impurities Moves to Step 2b
A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.


RELATED ARTICLES

More in GMPs/Validation

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.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
New Report Details Players and Pipelines in the Biosimilar Space
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
September 26, 2014
Author Guidelines

Click here