> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ICH Extractables, Leachables Guide
- URL: https://www.fdaweb.com/ich-extractables-leachables-guide/
- Published: 2025-08-07T12:00:00.000Z
- Updated: 2026-09-14T15:18:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159645

FDA has published the draft International Council for Harmonization (ICH) Q3E *Guideline for Extractables and Leachables* to receive public comment. The [document](https://database.ich.org/sites/default/files/ICH%5FQ3E%5FEWG%5FStep2%5FDraftGuideline%5F2025%5F0704.docx?ref=fdaweb.com) “provides a holistic framework and process for the assessment and control of leachable impurities to further expand the existing ICH guidelines on impurities….” It says it applies to the risk assessment and control of leachables in new drug products, including cell and gene therapy products. Drug/device combination products that require marketing authorizations and meet the definition of pharmaceutical or biological products are also in its scope, it says.

The guideline contains an Introduction, Scope, Risk Assessment and Control of Extractables and Leachables, Chemical Testing and Assessment, Analytical Evaluation Threshold, Safety Assessment, Glossary, References, and six appendices.