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1、Guidance for IndustryContainer Closure Systems for Packaging Human Drugs and BiologicsChemistry, Manufacturing and Controls Documentation行业指南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 1999TABLE OF CONTENTS 目录I. INTRODUCTION 介绍II. BACKGROUND 背景A. Definitions 定义B. CGMP, CPSC an
2、d USP Requirements on Containers and Closures. CGMP, CPSC和 USP 对容器和密封的要求C. 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 Origina
3、l 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D. Inhalation 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-Based 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 Reconstit
4、ution 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. General 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 Bu
5、lk Drug Products 用于散装药品的容器ATTACHMENT A 附件 AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件 BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南ATTACHMENT C 附件 CEXTRACTION STUDIES “提取性”研究ATTACHMENT D 附件 DABBREVIATIONS 缩略语ATTACHMENT E 附件 EREFERENCES 参考文献GUIDANCE FOR INDUSTRY1Container Closure Sy
6、stems for Packaging Human Drugs and BiologicsChemistry, Manufacturing and Controls DocumentationThis guidance document represents the Agencys 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
7、person and does not operate to bind FDA or the public. An alternative approach may be used 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。I INTRODUCTION 介绍This document is
8、intended to provide guidance on general principles2 for submitting information on packaging materials used for human drugs and biologics.3 This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics , issued in February 1987 and the packaging p
9、olicy 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 19
10、87 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 those 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.
11、 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
12、 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 composed, in whole or in part, of any poisonous or deleterious substance which ma
13、y render the contents injurious to health. In addition, section 502 of the Act states that a drug is considered misbranded if there are packaging omissions. Also, section 505 of the Act requires a full description of the methods used in, and the facilities and controls used for, the packaging of dru
14、gs (see 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 o
15、f the methods used in, the manufacturing, processing and packing of such drug. This includes facilities and controls used in the packaging a drug product. 法案的第 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 (e.g., glass,
16、high density polyethylene (HDPE) resin, metal) used 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）A packaging component means any single part of a container closure system. Typical components are containers (e.g., ampules, vials, bottles), container liners (e.g., tube liners), closures (e.g., screw caps, stoppers), closure liners, stopper overseals, container inner seals, administration ports (e.g., on large-volume parenterals (LVPs), overwraps,
