Extractables and leachables (E&L) represent an important class of impurities in pharmaceutical products that can arise from interactions between drug formulations and packaging materials, manufacturing components, or delivery devices, and migrate into drug products during manufacturing, storage, or administration. To address their potential impact on product quality, stability, and patient safety, the International Council for Harmonisation (ICH) has introduced the ICH Q3E guideline, which sets the standard for identifying, qualifying, and controlling E&L impurities.
This white paper presents a comprehensive, risk-based framework for implementing the ICH Q3E guideline, covering E&L concepts, sources, analytical methodologies, risk assessment strategies, analytical evaluation thresholds (AET), analytical uncertainty factors (AUF), and toxicological safety assessment approaches. It also proposes a holistic life cycle strategy and practical workflows to help pharmaceutical organizations ensure regulatory compliance and manage E&L risks effectively.
