ICH Q3E Draft Guideline on Extractables and Leachables Enters Public Consultation

On 1 August 2025, the draft ICH Q3E Guideline on Extractables and Leachables (E&Ls) reached Step 2b of the ICH process and entered public consultation. In Europe, comments are due by 18 December 2025. This is the first global harmonized guideline for E&Ls, aimed at supporting both regulators and applicants by improving transparency and providing a structured risk management framework for impurities in drug products and device components.

The draft outlines a quality risk management (QRM) process built on ICH Q9 principles. Each product requires its own risk assessment, lifecycle management, and collaboration between analytical chemists and safety experts. Key factors include packaging–formulation interactions, material properties, pre-treatment, storage conditions, and formulation leaching potential.

An appendix details workflows for E&L risk assessment. Safety evaluations under worst-case conditions are expected, though alternative approaches may apply for low-risk cases with proper justification.

05-09-2025