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# Guideline on Drug Stability Testing Released
- URL: https://www.fdaweb.com/guideline-on-drug-stability-testing-released/
- Published: 2025-06-23T12:00:00.000Z
- Updated: 2026-09-14T15:14:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159395

FDA has released an International Council for Harmonization (ICH) [draft guideline](https://www.fda.gov/media/187161/download?ref=fdaweb.com) entitled “Stability Testing of Drug Substances and Drug Products Q1.” The document outlines stability data expectations for drug substances and drug products, and includes recommendations on how science- and risk-based principles may be applied. It notes that principles of quality by design described in earlier ICH documents are applicable to the design of an overall stability strategy.

Additionally, the guideline illustrates the standard stability data package for drug substances and drug products, and provides input on alternative and scientifically justified approaches that encompass the variety of different situations that may be encountered due to specific scientific considerations and characteristics of the data being evaluated.

The document says that “alternative strategies based on science- and risk-based principles (e.g., as described in ICH Q8-Q11 and section IX of ICH Q12) for drug substances and drug products may be proposed by the applicant of a regulatory submission, leveraging quality risk management principles, pharmaceutical development data (e.g., as discussed in Section 2 – Development Studies Under Stressed and Forced Conditions), prior knowledge and modelling, (e.g., as discussed in Annex 2 — Stability Modelling).” Examples are also provided to show how science- and risk-based strategies may be applied.