ICH Q3E Guideline: Extractables & Leachables

ICH Q3E Framework for Extractables and Leachables (E&L)

The draft ICH Q3E Guideline establishes a harmonized, risk-based framework for managing extractables and leachables (E&L) throughout the lifecycle of drug products. Covering study design, toxicological qualification, acceptable exposure limits, and lifecycle monitoring, Q3E provides manufacturers with a consistent approach to assessing E&L risks while supporting patient safety and regulatory compliance.