FDA 行业指南 中英对照 待完成

Guidance for Industry

Container Closure Systems for Packaging Human Drugs and Biologics Chemistry, 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

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 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. 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 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

I．INTRODUCTION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 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 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. This is to prevent applicants or sponsors from

spending unnecessary time and effort in preparing a submission that the FDA may later