FDA 行业指南 中英对照 待完成.docVIP

Guidance for Industry Container 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 1999 TABLE OF CONTENTS目录 INTRODUCTION 介绍 BACKGROUND 背景 Definitions 定义 CGMP, CPSC and USP Requirements on Containers and Closures. CGMP, CPSC和USP对容器和密封的要求 Additional Considerations 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 Introduction 介绍 General Considerations 通常要求 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 Inhalation Drug Products 吸入性药品 Drug Products for Injection and Ophthalmic Drug Products 注射剂和眼科用药 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 Solid Oral Dosage Forms and Powders for Reconstitution 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 Comments 总体评述 Information in a Type III DMF 第III类DMF中包括的信息 BULK CONTAINERS 大包装容器 Containers for Bulk Drug Substances 用于原料药的容器 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 BiologicsChemistry, Manufacturing and Controls Documentation This 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 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