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Author name: Upasana Sonigra

Lhasa attended - E&Ls Europe 2025: Building defensible justifications under ICH Q3E

E&Ls Europe 2025: Building defensible justifications under ICH Q3E

Discuss, Innovate /

Insights on ICH Q3E, Extractables & Leachable (E&L) and risk assessment submissions Interpreting grey areas in the draft ICH Q3E guideline Earlier this month, the Lhasa Limited team, alongside Dr Lance Molnar, Head of Non-Clinical Operations and Risk Assessments at Viatris, and Dr Patricia Parris, Toxicology Impurity Risk Management at Pfizer, attended the Smithers E&L […]

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ICH Q3E - what the new guidelines mean for you

ICH Q3E – what the new E&L draft guideline means for you

Discuss, News /

The release of the ICH Q3E for public consultation marks a significant milestone for the pharmaceutical industry. It sets out a harmonised, risk-based framework for the assessment and control of organic impurities that migrate from packaging or manufacturing components into a final drug. For years, organisations navigated a complex web of regional expectations for extractables

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