FDA宣布ICH Q9(R1)质量风险管理最终指南可供获取
Q9(R1) Quality Risk Management
FDA宣布ICH Q9(R1)质量风险管理最终指南可供获取，该指南在ICH框架下制定，是2006年行业指南Q9质量风险管理的定向修订版。指南针对因生产质量问题导致的产品可及性风险、对QRM工作中形式化理解不足、风险决策不清晰以及风险评估和QRM输出主观性高等问题。该最终指南取代2022年6月15日发布的同名草案，档案编号为FDA-2022-D-0705。
材料说明Q9(R1)是2006年Q9的定向修订版，覆盖QRM形式化理解、风险决策与评估主观性等议题。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2022-D-0705
- 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 The guidance replaces the draft guidance “Q9(R1) Quality Risk Management” issued on June 15, 2022.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.
来源：FDA Pharmaceutical Quality Documents · fda.gov