The ICH Q3E draft “Guideline for Extractables and Leachables” and supporting document has reached Step 2b of the ICH Process on 1 August 2025 and entered the Step 3 public consultation period. 

The draft guideline presents a framework and process for the assessment and control of leachable impurities to further expand the existing ICH guidelines on impurities, including impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7).  The framework of this guideline follows the principles of risk management as described in ICH Q9. While the guideline includes materials characterization and process understanding, its primary purpose is to protect patient safety and product quality through assessment and control of leachables in the drug product. [ICH]