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This document is not for implementation, contains non-binding recommendations. This guidance is being distributed for comment purposes only.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