ICH Q3E Extractables and leachables - scientific guideline
Human
Scientific guidelines
This guideline presents a holistic framework and process for the assessment and control of extractable and leachable impurities and complements existing ICH guidelines on impurities, including impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7).
The framework of this guideline follows the principles of risk management as described in ICH Q9. While the guideline includes materials characterization and process understanding, its primary purpose is to protect patient safety and product quality through assessment and control of leachables in the drug product.
Keywords: Extractables, leachables, impurities.