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# ICH Q1 Stability Testing Guide Out for Comment
- URL: https://www.fdaweb.com/ich-q1-stability-testing-guide-out-for-comment/
- Published: 2025-04-22T12:00:00.000Z
- Updated: 2026-09-14T15:09:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159043

The International Council for Harmonization endorsed on 4/11 and released for public consultation the Q1 guidance *Stability Testing of Drug Substances and Drug Products*. The [document](https://database.ich.org/sites/default/files/ICH%5FQ1EWG%5FStep2%5FDraft%5FGuideline%5F2025%5F0411.pdf?ref=fdaweb.com) outlines the stability data expectations for drug substances and drug products and applies to marketed drug products, including those associated with registration and lifecycle/post-approval changes and, when applicable, master files.