> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ICH Quality Risk Management Guidance Published
- URL: https://www.fdaweb.com/ich-quality-risk-management-guidance-published/
- Published: 2023-05-03T12:00:00.000Z
- Updated: 2026-09-14T18:29:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154360

FDA has published the International Conference for Harmonization (ICH) Q9(R1) guidance, *Quality Risk Management*, to offer a systematic approach to quality risk management that leads to better, more informed, and timely decisions. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9r1-quality-risk-management?ref=fdaweb.com) says it specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle.

The ICH says Q9 is 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.

The guidance contains an Introduction, Scope, Principles of Quality Risk Management, General Quality Risk Management Process, Integration of Quality Risk Management into Industry and Regulatory Operations, Definitions, References, and two Annexes.