Container Closure Systems for Packaging Human Drugs and Biologics
Chemistry, Manufacturing and Controls Documentation
行业指南
我爱你的韩文人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件
指南发布者：美国FDA下属的CDER及CBER
发布日期：May 1999
TABLE OF CONTENTS目录
I.INTRODUCTION 介绍
II.BACKGROUND 背景
A.Definitions 定义
B.CGMP, CPSC and USP Requirements on Containers and Closures. CGMP, CPSC和US
P对容器和密封的要求alteco
enterpri cultureC.Additional Considerations 其他需要考虑的事项
III.QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS 包装组件的合格要求以及质量控制
A.Introduction 介绍
B.General Considerations 通常要求
C.Information That Should Be Submitted in Support of an Original Application for Any Drug Product 为支持任何药品的原始申请所必须提供的信息
tintinD.cecInhalation Drug Products 吸入性药品
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 液体口服和外用药品和外用给药系统
G.Solid Oral Dosage Forms and Powders for Reconstitution 口服固体剂型和待重新溶解的粉末
H.Other Dosage Forms 其他剂型
IV.POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更
V.TYPE III DRUG MASTER FILES 药品主文件 第III类
A.broughtGeneral Comments 总体评述
B.Information in a Type III DMF 第III类DMF中包括的信息
VI.BULK CONTAINERS 大包装容器
A.Containers for Bulk Drug Substances 用于原料药的容器
B.Containers for Bulk Drug Products 用于散装药品的容器
ATTACHMENT A 附件A
REGULATORY REQUIREMENTS 药政要求
ATTACHMENT B 附件B
COMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南
ATTACHMENT C 附件C
EXTRACTION STUDIES “提取性”研究
ATTACHMENT D 附件D
ABBREVIATIONS 缩略语
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
This guidance document reprents the Agency's current thinking on container closure systems for the packaging of human drugs and biological products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be ud if such approach satisfies the requirements of the applicable statute, regulations, or both.本指南代表了FDA目前对于人用药品和生物制品包装的容器/封装系统方面的看法。本指南不具强制力。与本指南不相同的替代措施也可采用，前提是能满足相应法律/法规的要求。 |
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冬至 英文
I．INTRODUCTION 介绍
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 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.4 This guidance is not intended to describe the information that should be provided about packaging operations associated with drug product manufacture. 本文件目的是为递交人用药品和生物制品的包装信息提供总体原则指南。本文件替代了FDA在1987年2月发布的另一份指南，以及替代了仿制药办公室在1995年6月30日向行业内发布的包装政策声明信。本指南不描述药品的包装操作。
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. 可以采取与本指南的内容不一致的措施，但是我们建议申请人就明显的差异预先与CDER或CBER的审核人员进行讨论。这样做的目的是为了避免申请人或发起人花费不必要的时间和努力准备申报资料，而这种申报资料经FDA认定是不可接受的。
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”）要求必须提供包装材料的充分信息。法案的第501(a)(3)部分规定，如果某个药品的包装材料含有有毒、有害的物质，导致药品损坏健康，那么该药品为劣药。另外，法案的第502部分规定，如果某药品在包装方面有缺失，则被认为是贴错标签。还有，法案第505部分要求详细描述包装药品时所用的方法，所用的设施和控制措施（见附件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. 法案的第人生如戏英文505(b)(1)(
D)部分规定，申请人必须完整描述该药品的生产、加工和包装。其中包括包装药品时的设施和控制措施。
A.Definitions5 定义
Materials of construction6 refer to the substances ., glass, high density polyethylene (HDPE) resin, metal) ud to manufacture a packaging component. 组成材料是指用来生产包装组件的物质（例如玻璃，HDPE树脂，金属）
ardsA packaging component means any single part of a container closure system. Typical components are containers ., ampules, vials, bottles), container liners ., tube liners), closures ., screw caps, stoppers), closure liners, stopper overals, container inner als, administration ports ., on large-volume parenterals (LVPs)), overwraps, administration accessories, and container labels. A primary packaging component means a packaging component that is or may be in direct contact with the dosage form. A condary packaging component means a packaging component that is not and will not be in direct
contact with the dosage form. 包装组件是指一个容器/封装系统的任何单独部分。通常的组件有容器（例如安瓿，西林瓶，瓶子），容器垫，封装，封装垫…….等，包括给药附件和容器标签。there是什么意思一级包装组件是指与制剂直接接触的组件，或者可能会直接接触的组件。二级包装组件是指不会与制剂直接接触的组件。
