FDA发布PET药品CGMP最终指南（Docket FDA-1998-D-0025）
PET Drug Products—Current Good Manufacturing Practice (CGMP)
FDA发布PET药品现行药品生产质量管理规范（CGMP）最终指南，帮助PET药品生产者理解FDA对CGMP合规的考虑。指南由CDER发布，涵盖学术和商业PET药品生产设施的资源、程序和文件，并给出可用于符合CGMP要求的方法或程序示例。文件编号为FDA-1998-D-0025，FDA说明可随时就该指南提交在线或书面意见。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-1998-D-0025
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.
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-1998-D-0025.
来源：FDA Pharmaceutical Quality Documents · fda.gov