FDA发布药品CGMP科学与技术问题正式争议解决最终指南（FDA-2003-D-0369）
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
FDA宣布发布面向行业的最终指南《药品CGMP相关的科学和技术问题正式争议解决》，编号为FDA-2003-D-0369。该指南描述一个两层的正式争议解决程序，用于处理FDA对药品生产商进行CGMP检查期间出现的科学与技术争议。指南意见可按21 CFR 10.115(g)(5)随时提交。
该文件说明了FDA在药品CGMP检查中处理科学与技术争议的两层正式程序，便于读者核对适用环节。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2003-D-0369
- Issued by:
-
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.” The guidance describes a formal, two-tiered dispute resolution process intended to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) that arise during FDA inspections of pharmaceutical manufacturers.
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-2003-D-0369.
来源：FDA Pharmaceutical Quality Documents · fda.gov