FDA 行业指南 中英对照 待完成Word文档格式.docx

1、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 and 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

2、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 Dr

3、ug 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.General Comments 总体评述B.Information in a Type III DMF 第III类DMF中

4、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

5、件D ABBREVIATIONS 缩略语ATTACHMENT E 附件E REFERENCES 参考文献GUIDANCE FOR INDUSTRY1Chemistry, 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 con

6、fer any rights for or on any 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。IINTROD

7、UCTION 介绍This document is 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 Februar

8、y 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

9、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 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

10、 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 BACKGROU

11、ND 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 composed， in whole or in part， of any poisonous or deleterious substance

12、which may 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 packag

13、ing of drugs （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 descripti

14、on of 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

15、， 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