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GUIDANCE DOCUMENT

Q3E Guideline for Extractables and Leachables November 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-4678

Docket Number:
FDA-2025-D-4678
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Q3E Guideline for Extractables and Leachables” and a draft supporting document entitled “Supporting Documentation: Class 3 Leachable Monographs.” The draft guidance and supporting document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance presents a holistic framework and process for the assessment and control of extractables and leachables (E&L) for pharmaceutical products. The draft guidance builds upon ICH impurity guidances on new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH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). In addition to outlining E&L safety assessment principles, the draft guidance includes draft supporting documentation of Class 3 leachable monographs. The draft guidance is intended to provide approaches to risk-based assessment and control of E&L to ensure patient safety and pharmaceutical product quality.

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