On 1 August, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed the release of the ICH Q3E draft Guideline for public consultation.
This new guideline applies to the risk assessment and control of leachables — chemical entities that migrate from manufacturing components, packaging, or delivery devices into a drug product under standard manufacturing and labelled storage conditions.
Scope of the Guideline
- Applies to new drug products, including cell and gene therapy products.
- Covers drug–device combination products requiring marketing authorisation and meeting the definition of pharmaceutical or biological products.
- Does not apply to products in clinical research stages, except where there is high risk to the patient.
Integration with Existing Guidelines
ICH Q3E provides a holistic framework for assessing and controlling leachable impurities, complementing and expanding upon existing ICH impurity guidelines: ICH Q3A – Impurities in new drug substances, ICH Q3B – Impurities in new drug products, ICH Q3C – Residual solvents, ICH Q3D – Elemental impurities, ICH M7 – DNA-reactive (mutagenic) impurities, and ICH Q9 – Risk management principles.
Organic leachables are the primary focus of this guideline. The safety assessment of elemental leachables are addressed by ICH Q3D and thus out of scope for this guideline.
This draft aims to provide a consistent and risk-based approach to controlling leachables, ensuring patient safety while streamlining regulatory expectations across regions.
