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# Guide on Quality Risk Management
- URL: https://www.fdaweb.com/guide-on-quality-risk-management/
- Published: 2023-05-05T12:00:00.000Z
- Updated: 2026-09-14T18:29:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154380

*Federal Register* notice: FDA has made available a final guidance entitled “Q9(R1) Quality Risk Management.” The International Council for Harmonization document addresses product availability risks due to manufacturing quality issues, lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work, lack of clarity on risk-based decision-making, and high levels of subjectivity in risk assessments and QRM outputs. It also discusses quality risk management principles and tools that can be applied to different aspects of pharmaceutical quality. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-04/pdf/2023-09517.pdf?ref=fdaweb.com).