Javier López

Toxicology Expert

4 articles

ToxicologyQuality Assurance1 abr 2026 7 min

Extractables and Leachables (E&L): Reviewing the Current Regulatory Landscape

Extractables and leachables requirements are evolving with draft ICH Q3E. Learn how companies can prepare for future E&L regulatory expectations.

Quality Assurance20 ago 2025 4 min

Preparing for an Extractables and Leachables (E&L) Risk Evaluation: Key Topics to Consider

Learn the key topics to consider before starting an Extractables and Leachables risk assessment, from product type to testing strategy and lifecycle management.

Regulatory Affairs13 ago 2025 2 min

ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation

The International Council for Harmonization (ICH) has advanced the long-anticipated Guideline for Extractables and Leachables (Q3E) to Step 2b, initiating the global public consultation phase.

Toxicology23 abr 2025 4 min

Why Extractables and Leachables Matter in Pharma Risk Assessments

Extractables and leachables can impact drug safety and stability. Learn what they are, why they matter, and how they are assessed in pharmaceutical manufacturing.

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