FDA发布药品生产及生物研究监测设施远程交互评估指南草案
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
FDA发布药品生产及生物研究监测设施远程交互评估指南草案，说明如何请求和开展自愿远程交互评估。草案为1级指南，不用于实施，仅含非约束性建议，案卷编号为FDA-2023-D-4416。指南适用于药品生产、加工、包装、配制或储存设施，以及BIMO项目覆盖的药品设施，公众可随时按21 CFR 10.115(g)(5)提交意见。
材料列出FDA对药品生产及生物研究监测设施开展远程交互评估的草案范围与征求意见安排，便于读者定位适用设施类型。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2023-D-4416
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Veterinary Medicine
FDA is issuing this guidance to describe how we request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under FDA’s bioresearch monitoring (BIMO) program.
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-2023-D-4416.
来源：FDA Pharmaceutical Quality Documents · fda.gov