FDA发布人用药品与生物制品包装容器密闭系统最终指南
Container Closure Systems for Packaging Human Drugs and Biologics
FDA发布《人用药品与生物制品包装容器密闭系统指南》最终版，就提交人用药品和生物制品包装材料信息的一般原则提供指导，文件编号为FDA-1997-D-0145。该指南替代1987年2月发布的包装文件提交指南，以及1995年6月30日仿制药办公室致行业的包装政策声明。指南不涉及药品生产相关包装操作的信息，评论可按21 CFR 10.115(g)(5)随时提交。
该指南为1999年发布的正式文件，取代1987年指南及1995年政策声明，说明人用药品与生物制品包装材料的提交原则。
GUIDANCE DOCUMENT
Container Closure Systems for Packaging Human Drugs and Biologics Guidance for Industry July 1999
Final
- Docket Number:
- FDA-1997-D-0145
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This document is intended to provide guidance on general principles for submitting information on packaging materials used for human drugs and biologics. This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics, issued in February 1987 and the packaging policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs. This guidance is not intended to describe the information that should be provided about packaging operations associated with drug product manufacture.
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-1997-D-0145.
来源：FDA Pharmaceutical Quality Documents · fda.gov