T HE C OMMON T ECHNICAL D OCUMENT FOR THE R EGISTRATION OF P HARMACEUTICALS FOR H UMAN U SE: Q UALITY
人用药品注册的通用技术文件：质量
Q UALITY O VERALL S UMMARY OF M ODULE 2
模块2：质量综述
M ODULE 3 : Q UALITY
模块3：质量
ICH H ARMONISED T RIPARTITE G UIDELINE
ICH协调的三方指南
TABLE OF CONTENTS
目录
MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 模块2：通用技术文件综述
2.3 : QUALITY OVERALL SUMMARY (QOS)
2.3：质量综述（QOS）
INTRODUCTION
介绍
2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER)
2.3.S 原料药（名称，制造商）云的种类
2.3.S.1 General Information (name, manufacturer)
火和土相生还是相克
2.3.S.1 一般信息
2.3.S.2 Manufacture (name, manufacturer)
2.3.S.2 制造商
2.3.S.3 Characterisation (name, manufacturer)
2.3.S.3 特性
2.3.S.4 Control of Drug Substance (name, manufacturer)
2.3.S.4 原料药控制
2.3.S.5 Reference Standards or Materials (name, manufacturer)
2.3.S.5 标准品或对照品
2.3.S.6 Container Closure System (name, manufacturer)
2.3.S.6 容器密闭系统
燃烧的英文2.3.S.7 Stability (name, manufacturer)
2.3.S.7 稳定性
MODULE 3 : QUALITY
摸块3：质量
3.1. TABLE OF CONTENTS OF MODULE 3
3.1. 模块3目录
3.2. BODY OF DATA
3.2. 主体数据
3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER)
3.2.S 原料药（名称，制造商）
3.2.S.1 General Information (name, manufacturer)
九十年代电视剧3.2.S.1 一般信息
3.2.S.1.1 Nomenclature (name, manufacturer)
3.2.S.1.1 命名
特岗教师报名3.2.S.1.2 Structure (name, manufacturer)
3.2.S.1.2 结构
3.2.S.1.3 General Properties (name, manufacturer)
3.2.S.1.3 一般性质
3.2.S.2 Manufacture (name, manufacturer)
3.2.S.2 制造
3.2.S.2.1 Manufacturer(s) (name, manufacturer)
3.2.S.2.1 制造商
3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer)
3.2.S.2.2 制造工艺和工艺控制的叙述
3.2.S.2.3 Control of Materials (name, manufacturer)
3.2.S.2.3 物料的控制
3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer)
3.2.S.2.4 关键步骤和中间体的控制
3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer)
顽皮的小猫3.2.S.2.5 工艺验证和/或评估
3.2.S.2.6 Manufacturing Process Development (name, manufacturer)
3.2.S.2.6 制造工艺开发
3.2.S.3 Characterisation (name, manufacturer)
3.2.S.3 特性
3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer)
3.2.S.3.1 结构和其它特性的阐明
3.2.S.3.2 Impurities (name, manufacturer)
五言对联3.2.S.3.2 杂质
3.2.S.4 Control of Drug Substance (name, manufacturer)
3.2.S.4 原料药的控制
3.2.S.
4.1 Specification (name, manufacturer)
3.2.S.
4.1 质量标准
3.2.S.
4.2 Analytical Procedures (name, manufacturer)
3.2.S.
4.2 分析方法
3.2.S.
4.3 Validation of Analytical Procedures (name, manufacturer)
3.2.S.
4.3 分析方法的验证
3.2.S.
4.4 Batch Analys (name, manufacturer)
3.2.S.
4.4 批分析
3.2.S.
4.5 Justification of Specification (name, manufacturer)
3.2.S.
4.5 质量标准的论证
3.2.S.5 Reference Standards or Materials (name, manufacturer)
3.2.S.5 标准品或对照品
3.2.S.6 Container Closure System (name, manufacturer)
3.2.S.6 容器密闭系统
3.2.S.7 Stability (name, manufacturer)
3.2.S.7 稳定性
3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer)
3.2.S.7.1 稳定性概要和结论
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer) 3.2.S.7.2 批准后的稳定性草案和稳定性承诺
3.2.S.7.3 Stability Data (name, manufacturer)
3.2.S.7.3 稳定性数据
大海啊故乡教案MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES
模块2：通用技术文件综述
2.3 : QUALITY OVERALL SUMMARY (QOS)
2.3：质量综述(QOS)
The Quality Overall Summary (QOS) is a summary that follows the scope and the outline of the Body of Data in Module 3. The QOS should not include information, data or justification that was not already included in Module 3 or in other parts of the CTD.
质量综述（QOS）由模块3中主体数据的范围和要点产生的概述。QOS不应包含模块3或CTD其它的部分中未包含的信息，数据或论证。
The QOS should include sufficient information from each ction to provide the Quality reviewer with an overview of Module 3. The QOS should also emphasi critical key parameters of the product and provide, for instance, justification in cas where guidelines were not followed. The QOS should
include a discussion of key issues that integrates information from ctions in the Quality Module and supporting information from other Modules (e.g. qualification of impurities via toxicological studies discusd under the CTD-S module), including cross-referencing to volume and page number in other Modules.
QOS应包含每一部分的足够信息以提供给质量审核者模块3综述。QOS也应强调产品的关键参数，如，提供论证指南未被遵循的情况。QOS应包含对关键问题的讨论，这些讨论整合了来自质量模块章节的信息，及其它模块的辅助信息。（如，在CTD-S模块中讨论的，经由毒理研究杂质的界定），包括相互参照其它模块的容量和页码。
This QOS normally should not exceed 40 pages of text, excluding tables and figures. For biotech products and products manufactured using more complex process, the document could be longer but normally should not exceed 80 pages of text (excluding tables and figures).
QOS通常不应有超过40页的正文，（不包括表格和图片）。对于生化产品和采用较复杂工艺制造的产品，文件的正文可以长点通常不应超过80页（不包括表格和图片）。
The italicid text below indicates where tables, figures, or other items can be imported directly from Module 3. 下面斜体的正文表明，在这里可以直接插入模块3中的表格，图片或其他的项目。
INTRODUCTION
介绍
The introduction should include proprietary name, non-proprietary name or common name of the drug substance, company name, dosage form(s), strength(s), route of administration, and propod indication(s).
