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# ICH Quality Risk Management Guide Adopted by FDA
- URL: https://www.fdaweb.com/ich-quality-risk-management-guide-adopted-by-fda/
- Published: 2023-01-20T12:00:00.000Z
- Updated: 2026-09-14T18:12:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153592

The International Conference on Harmonization (ICH) has released a [final guide](https://database.ich.org/sites/default/files/ICH%5FQ9%28R1%29%5FGuideline%5FStep4%5F2022%5F1219.pdf?ref=fdaweb.com) entitled *Quality Risk Management Q9 (R1)*, which has been adopted by FDA for implementation. The document is intended to offer a systematic approach to quality risk management that leads to better informed decisions. “It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment,” ICH says.

Specifically, the guide discusses principles and some of the tools of quality risk management that can help make more effective and consistent risk-based decisions, both by regulators and industry, regarding drug substance and drug product quality across the product lifecycle, ICH says. “It is not intended to create any new expectations beyond the current regulatory requirements,” it says. “An understanding of formality in quality risk management may lead to resources being used more efficiently, where lower risk issues are dealt with via less formal means, freeing up resources for managing higher risk issues and more complex problems that may require increased levels of rigor and effort.”

According to the guide, quality risk management activities are usually directed by interdisciplinary teams. “When teams are formed, they should include experts from the appropriate areas (e.g., quality unit, product development, business development, engineering, regulatory affairs, production operations, sales and marketing, supply chain, legal, statistics and clinical) in addition to individuals who are knowledgeable about the quality risk management process,” it says, adding that decision makers should:

- take responsibility for coordinating quality risk management across various functions and departments within the organization;
- assure that a quality risk management process is defined, deployed and reviewed, and that adequate resources and knowledge are available; and
- assure that subjectivity in quality risk management activities is managed and minimized, to facilitate scientifically robust risk-based decision-making.