ICH: ICH Q3 Draft on Extractables and Leachables Released

On 1 August 2025, the International Council for Harmonisation (ICH) endorsed the draft version of the ICH Q3E Guideline for Extractables and Leachables and made it available for public consultation. The guideline addresses a gap in the ICH's current guidelines on impurities and comes along with a supporting document on Class 3 leachable monographs.

This consensus document establishes a framework and process for assessing and controlling leachable impurities, expanding the existing ICH guidelines on impurities. These include impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), elemental impurities (ICH Q3D), and DNA-reactive (mutagenic) impurities (ICH M7).

The framework of this guideline follows the risk management principles described in ICH Q9. While the guideline covers the characterisation of materials and understanding of processes, its primary objective is to ensure patient safety and product quality through assessment and control processes. Taking the risk management principles into account, the guideline outlines basic criteria for chemical testing and evaluation.

The focus is on the safety assessment of analytical and toxicological thresholds.

The guideline applies to new chemical and biological medicinal products, including cell and gene therapies, as well as combination products consisting of medicinal products and medical devices. All dosage forms are considered. The supporting and practical annexes detail

• typical workflows for assessing those impurities;
• the various types of studies;
• the calculations for acceptable exposure thresholds (AET) and categorise potency classes;
• the methods for establishing exposure limits and provides
• monographs for Class I leachables.

Source:

ICH: ICH Q3E Draft Guideline

ICH: Guideline supporting documentation