Extractables & Leachables in Pharma

About this white paper

For decades, E&L assessment relied on a patchwork of guidance: ICH Q3A-Q3D, EMA's 2005 packaging guideline, PQRI's threshold methodology, and USP <1663>/<1664>. It worked, but inconsistently, creating friction for global submissions and repeated regulatory questions across jurisdictions.

This whitepaper, written by toxicology expert Javier López, explains how ICH Q3E consolidates that fragmented history into a single, lifecycle-based framework. It walks through the three pillars behind the guideline, clarifies exactly what changes for organizations with existing E&L programs, and sets out a concrete action plan for the run-up to 2027.

For teams with mature E&L programs already built on sound science, the message is reassuring: the underlying science hasn't moved. What has changed is the level of documentation, traceability, and lifecycle thinking regulators now expect, and that shift is worth acting on well before the guideline reaches final adoption.

Key Takeaways

• Why ICH Q3E doesn't rewrite E&L science, but introduces a lifecycle-based structure built around risk assessment, risk control, and risk review as a continuous cycle
• What actually changes: the shift from E&L as a one-time submission activity to an ongoing process reassessed whenever materials, suppliers, or manufacturing processes change
• Why documentation and traceability, not just analytical data, are now the areas regulators will scrutinize most closely, including how AET calculations are derived and defended
• Which triggers should prompt an E&L reassessment during the product lifecycle, from scale-up and supplier changes to shelf-life extensions and reformulation
• The six concrete actions Marketing Authorization Holders should prioritize now (review, strengthen, validate, reassess, align, adopt) to be ready before Q3E's anticipated 2027 implementation

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