# Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/q3e-guideline-for-extractables-and-leachables-supporting-documentation-class-3-leachable-monographs/f8e13869-de0e-497a-9342-98fc75f65f6c

> FDA guidance document: Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs. Issue date: November 28, 2025. Get complete insights and analysis.

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## Details

- Title: Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2025-11-28
- Comment Close Date: 2026-01-30
- Last Changed: 2025-12-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2025-D-4678">FDA-2025-D-4678</a>

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