Guidance for Industry
Container Closure Systems for Packaging Human Drugs and Biologics 包装人用药和生物制品的
容器密封系统
CHEMISTRY, MANUFACTURING, AND CONTROLS
DOCUMENTATION102
化学、生产和控制类文档
[Acrobat version of this document]
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
Center for Biologics Evaluation and Rearch (CBER)
May 1999我为什么要上学
Additional copies are available from:
Office of Training and Communications
超时空效应Division of Communications Management
Drug Information Branch, HFD-210 Center for Drug Evaluation and Rearch (CDER)
5600 Fishers Lane
Rockville, Maryland 20857
(Tel) 301-827-4573
(Internet) v/cder/guidance/index.htm
or
Office of Communications
Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Rearch (CBER)
1401 Rockville Pike
Rockville, Maryland 20852-1448
(Fax) 888-CBERFAX or 301-827-3844 (Voice Information) 800-835-4709 or 301-827-1800
(Internet) v/cber/guidelines.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER) Center for Biologics Evaluation and Rearch (CB ER)
May 1999
手机费电
Table of Contents很笔画
I. INTRODUCTION /简介
II. BACKGROUND/背景知识
A. Definitions/定义
最后一片树叶B. CGMP, CPSC and USP Requirements on Containers and
Closures /CGMP，CPSC和USP对容器和密封件的要求
C. Additional Considerations /其它考虑
III. QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS /包装组份的确认和质量控制
A. Introduction/介绍
B. General Considerations/一般考虑
C. Information That Should Be Submitted in Support of an Original
Application for Any Drug Product/药品初次申报需要提供的包材
部分资料
D. Inhalation Drug Products/吸入剂
E. Drug Products for Injection and Ophthalmic Drug Products
注射剂和眼科用药
F. Liquid-Bad Oral and Topical Drug Products and Topical
Delivery Systems 液体口服用药和局部用药以及局部药物传递
系统
G. Solid Oral Dosage Forms and Powders for Reconstitution家常炒藕片的做法
口服固体剂型和粉剂
H. Other Dosage Forms/其它剂型
IV. POSTAPPROVAL PACKAGING CHANGES /批准后的包装变更
V. TYPE III DRUG MASTER FILES /第三类DMF
A. General Comments/总论
B. Information in a Type III DMF /第三类DMF资料
VI. BULK CONTAINERS /散装容器
改变的英语A. Containers for Bulk Drug Substances/散装原料药容器
B. Containers for Bulk Drug Products /散装制剂容器
ATTACHMENT A /附件A
REGULATORY REQUIREMENTS/法规要求
ATTACHMENT B /附件B
COMPLIANCE POLICY GUIDES THAT CONCERN
PACKAGING/与包装有关的法规遵守政策指南
EXTRACTION STUDIES/萃取法研究
ATTACHMENT D /附件D
ABBREVIATIONS/缩写词
ATTACHMENT E /附件E
REFERENCES/参考文献
GUIDANCE FOR INDUSTRY1
CONTAINER CLOSURE SYSTEMS FOR PACKAGING
HUMAN DRUGS AND BIOLOGICS CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION I. INTRODUCTION/导言
This document is intended to provide guidance on general principles2 for submitting information on packaging materials ud for human drugs and biologics.3 This guidance superdes the FDA Guid
eline 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.4 This guidance is not intended to describe the information that should be provided about packaging operations associated with drug product manufacture.阿苏火山
本文件旨在为人用药物和生物制剂的包装材料资料的递交提供总体原则方面的指导。本指南代替了FDA于1987年2月公布的《人用药物和生物制剂包装申报指南》和仿制药办公室于1995年6月30日发表的致医药行业的一封信（包装政策论）。本指南不对与药品生产有关的包装操作的进行说明。
Approaches which differ from tho described in this guidance may be followed, but the applicant is encouraged to discuss significant variations in advance with the appropriate CDER chemistry review staff or CBER review staff. This is to prevent applicants or sponsors from spending unnecessary time and effort in preparing a submission that the FDA may later determine to be unacceptable.
申请人可以采用与本指南所述不同的其他方法。但FDA鼓励申请人事先与药物评审与研究中心的化学评审员或生物评审与研究中心的评审员就主要的不同点进行讨论。目的是为了防止申请人或赞助人花不必要的时间和精力去准备一些很可能会被FDA拒绝的资料。
II. BACKGROUND/背景
The Federal Food, Drug, and Cosmetic Act (the Act) mandates the need for adequate information related to packaging materials. Section 501(a) (3) of the Act states that a drug is deemed to be adulterated "if its container is compod, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious " In addition, ction 502 of the Act states that a drug is considered misbranded if there are packaging omissions. Also, ction 505 of the Act requires a full description of the methods ud in, and the facilities and controls ud for the packaging of drugs (e Attachment A).
联邦食品、药品和化妆品法案（简称法案）对包装材料作了要求。法规第501(a)(3)条规定，一种药物“如果其容器含有有毒或有害物质，影响到药品，从而导致药品对人体产生危害”，则该药视为假药。此外，法规第502部分规定，一种药物如果出现包装疏漏，则视为贴错标签的产品。同样，法规第505部分要求对药品包装使用的方法、设施和控制进行详细说明（见附录A）。
Section 505(b)(1)(D) of the Act states that an application shall include a full description of the methods ud in, the manufacturing, processing and packing of such drug. This includes facilities and controls ud in the packaging a drug product.
