FDA 发布最终版 ICH Q10 药品质量体系指南（FDA-2007-D-0370）
Q10 Pharmaceutical Quality System
FDA 发布最终版 ICH Q10 药品质量体系指南，案卷编号为 FDA-2007-D-0370，由 CBER 与 CDER 发布。该指南旨在帮助制药商建立有效的质量管理体系，即文中所述药品质量体系，并说明该术语指 ICH Q10 模型。FDA 表示可随时就该指南在线或书面提交评论。
材料明确该文件为最终版并指向 ICH Q10 模型，可帮助读者确认文件状态与适用范围。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2007-D-0370
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model.
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-2007-D-0370 .
来源：FDA Pharmaceutical Quality Documents · fda.gov