Extractables And Leachables: Why They're A Critical Part Of Your Contamination Control Strategy Under EU GMP Annex 1

By Will Parker – Technology Manager, Extractables and Leachables, West Pharmaceutical Services

The revision of EU GMP Annex 1 has heightened expectations for sterility assurance, placing extractables and leachables (E&L) at the center of modern contamination control strategies. While extractables are chemical substances drawn out under extreme conditions, leachables migrate into drug products during normal use, posing direct risks to patient safety and product stability. Primary packaging represents the most significant risk due to extended contact time, though process equipment and single-use systems also require rigorous assessment.

A robust strategy integrates standards like USP <1663> and ICH Q3E to map risks across the entire manufacturing process. Success depends on understanding how drug chemistry, material composition, and storage conditions influence chemical migration. By embedding these risk-based principles into a comprehensive Contamination Control Strategy, manufacturers can satisfy regulatory scrutiny and ensure long-term compliance.