Do you have comments on the Guideline ICH Q9 Quality Risk Management?
The last date for comment submission is 15th July 2022.
Submit Comments by 07/15/2022Submit Comments OnlineAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.If unable to submit comments online, please mail written comments to:Dockets ManagementFood and Drug Administration5630 Fishers Lane, Rm 1061Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-0705
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry, and it is evident that quality risk management is a valuable component of an effective quality system.