FDA行业指南中英对照待完成.docxVIP

REGULATORY REQUIREMENTS REGULATORY REQUIREMENTS 药政要求 Guida nee for In dustry Container Closure Systems for Paekag ing Huma n Drugs and Biologies Chemistry, Manu faetur ing and Con trols Doeume ntati on 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 1999 TABLE OF CONTENTS 目录 INTRODUCTION 介绍 BACKGROUND 背景 A. Defin iti ons 定义 B. CGMP, CPSC and USP Requireme nts on Co ntain ers and Closures. CGMP, CPSC 和 USP对容器和密封的要求 C. Additio nal Con sideratio ns 其他需要考虑的事项 QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS 包装组件的合 格要求以及质量控制 In troduetion 介绍 Ge neral Con sideratio ns 通常要求 In formati on That Should Be Submitted in Support of an Orig inal Applieati on for Any Drug Produet为支持任何药品的原始申请所必须提供的信息 In halation Drug Produets 吸入性药品 Drug Produets for Injeetio n and Ophthalmie Drug Produets 注射剂和眼科用药 Liquid-Based Oral and Topieal Drug Produets and Topieal Delivery Systems 液体口月服 和外用药品和外用给药系统 Solid Oral Dosage Forms and Powders for Reeo nstitution 口服固体剂型和待重新溶解 的粉末 Other Dosage Forms 其他剂型 POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更 TYPE III DRUG MASTER FILES 药品主文件 第 III 类 General Comme nts 总体评述 In formation in a Type III DMF 第 III 类 DMF 中包括的信息 BULK CONTAINERS 大包装容器 Con tai ners for Bulk Drug Substa nces 用于原料药的容器 Con tai ners for Bulk Drug Produets 用于散装药品的容器 ATTACHMENT A 附件 A ATTACHMENT B 附件 B 关于包装，所适用的政策指COMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指 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 1 GUIDANCE FOR INDUSTRY INTRODUCTION 介绍 This docume nt is inten ded to provide guida nee on gen eral prin ciples for submitt ing in formati on on packag ing materials used for huma n drugs and biologics. This guida nee supersedes theFDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics ,issued in February 1987 and the packag ing policy stateme nt issued in a letter to in dustry dated June 30, 1995 from the Office of Gen eric Drugs. This guida nce is not in