FDA Q9(R1) Quality Risk Management - Guidance Document - Feedback needed

Please consider to provide the FDA with feedback on this guidance!

This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

This document is not for implementation, contains non-binding recommendations. This guidance is being distributed for comment purposes only.

Link to the document: https://www.fda.gov/media/159218/download

To submit comments:


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

Deadline to submit comments: 07/15/2022***