Regulators are rapidly converging on tougher, more standardised expectations for extractables and leachables (E&L), elevating E&L analysis from a late-stage testing exercise to a lifecycle risk-management priority. The draft ICH Q3E guideline, released for global consultation, marks a significant regulatory shift toward harmonised, risk-based assessment and control of leachable impurities across regions. This development signals heightened scrutiny on how pharmaceutical and biotech companies design extractables studies, justify leachable study strategies, and demonstrate patient safety through robust toxicological assessment.
As advanced modalities continue to expand, including inhalation products, biologics, antibody-drug conjugates (ADCs), and cell and gene therapies, manufacturers face persistent challenges in managing extractables and leachables risk. These include defining and defending Analytical Evaluation Thresholds (AET), applying Safety Concern Threshold concepts, calculating and using Permissible Daily Exposures (PDEs), and ensuring analytical methods meet regulatory expectations for detection, identification, and quantitation of volatile, semi-volatile, non-volatile, and inorganic compounds. Regulators now expect risk management of leachables to be applied throughout the product lifecycle, supported by Quality by Design principles, data quality oversight, and clear justification of analytical and toxicological decisions.
To support industry professionals navigating these evolving requirements, Fleming will deliver the Extractables & Leachables Analysis online live training course on 10–12 March 2026, 14:00–18:00 CET. The programme focuses on the practical implementation of ICH Q3E requirements, including AET calculation exercises, risk-based extractables and leachables study design, sources of extractables and leachables, and toxicological risk assessment workflows. The agenda also addresses analytical uncertainty, validation and verification of E&L data, assessment of contract research organisation data quality, regulatory requirements beyond ICH Q3E, and future developments such as standardisation initiatives, artificial intelligence, and mathematical modelling.
Designed for analytical scientists, toxicologists, regulatory affairs professionals, packaging and device engineers, and pharmaceutical R&D leaders, the training equips participants with the expertise required to manage extractables and leachables risk effectively, reduce regulatory delays, and meet rising global compliance expectations.
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