FDA发布人用药品和生物制品包装容器密封系统问答指南最终版
Container Closure Systems for Packaging Human Drugs and Biologics: Questions and Answers
FDA发布《人用药品和生物制品包装容器密封系统问答》最终版指南，以问答形式回应申请人就该容器密封系统指南向CDER提出的问题。文件由CBER与CDER共同发布，属于配套该指南的问答说明。FDA表示可随时依据21 CFR 10.115(g)(5)提交意见，书面意见寄至Dockets Management。
GUIDANCE DOCUMENT
Final
- Docket Number:
- None found
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This document provides questions and answers relating to the guidance on Container Closure Systems for Packaging Human Drugs and Biologics (the guidance). The questions are based on those posed to CDER by applicants.
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: None found.
来源：FDA Pharmaceutical Quality Documents · fda.gov