U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Q9(R1) Quality Risk Management
  1. Search for FDA Guidance Documents


Q9(R1) Quality Risk Management May 2023

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is a targeted revision of the 2006 guidance for industry “Q9 Quality Risk Management” and 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. The revision is intended to provide guidance on quality risk management principles and tools that can be applied to different aspects of pharmaceutical quality. The guidance replaces the draft guidance “Q9(R1) Quality Risk Management” issued on June 15, 2022.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0705.

Back to Top