ICH_Q11_原料药开发与制造-中英对照
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3.2 Submission of Manufacturing Process Development Information 制造工艺开发信息的申报................ 12 3.2.1 Overall Process Development Summary 全面工艺开发总结........................................................ 12 3.2.2 Drug Substance CQAs 原料药的关键质量属性 ........................................................................... 13 3.2.3 Manufacturing Process History 制造工艺历史.............................................................................. 13 3.2.4 Manufacturing Development Studies 制造开发研究..................................................................... 14
3.1 General Principles 总则............................................................................................................................... 4 3.1.1 Drug Substance Quality Link to Drug Product 原料药质量与制剂产品的联系 ............................ 4 3.1.2 Process Development Tools 工艺开发工具 ..................................................................................... 5 3.1.3 Approaches wenku.baidu.como Development 开发方法 ............................................................................................ 5 3.1.4 Drug Substance Critical Quality Attributes 原料药关键质量属性（CQA） ................................. 7 3.1.5 Linking Material Attributes and Process Parameters to Drug Substance CQAs 物料属性及工艺参 数与原料药关键质量属性的联系............................................................................................................ 8 3.1.6 Design Space 设计空间 .................................................................................................................. 10
Page 1 of 45
ICH Q11 原料药开发和制造
中英对照
6.1.1 Approaches to Developing a Control Strategy 开发控制策略的方法 ........................................... 21
6.1.2 Considerations in Developing a Control Strategy 开发控制策略的考虑事项 .............................. 22
5.1 General Principles 总则............................................................................................................................. 16 5.1.1 Selection of Starting Materials for Synthetic Drug Substances 化学合成原料药起始物料的筛选
4. Description of Manufacturing Process and Process Controls 制造工艺描述与工艺控制 ................................. 15 5. Selection of Starting Materials and Source Materials 起始物料筛选及物料来源 ............................................. 16
ICH Q11 原料药开发和制造
中英对照
DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL
ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES)
Q11
Current Step 4 version dated 1 May 2012
TABLE OF CONTENTS
1. Introduction 介绍................................................................................................................................................... 3 2. Scope 范围............................................................................................................................................................. 4 3. Manufacturing Process Development 制造工艺开发 ........................................................................................... 4
................................................................................................................................................................. 16 5.1.2 Selection of Starting Materials for Semi-Synthetic Drug Substances 半合成原料药起始物料的筛 选 ............................................................................................................................................................. 18 5.1.3 Selection of Source and Starting Materials for Biotechnological/Biological Drug Substances 生物 技术/生物制品起始物料的选择............................................................................................................. 18 5.2 Submission of Information for Starting Material or Source Material 起始物料或物料来源的信息申报 19 5.2.1 Justification of Starting Material Selection for Synthetic Drug Substances 合成原料药起始物料的 选择依据 ................................................................................................................................................. 19 5.2.2 Justification of Starting Material Selection for Semi-Synthetic Drug Substances 半合成原料药起 始物料的选择依据.................................................................................................................................. 20 5.2.3 Qualification of Source or Starting Materials for Biotechnological/Biological Drug Substances 生 物技术/生物制品原料药源物料或起始物料源物料的确认................................................................. 20 6. Control Strategy 控制策略 .................................................................................................................................. 21 6.1 General Principles 总则............................................................................................................................. 21
6.2 Submission of Control Strategy Information 控制策略信息的申报 ........................................................ 23
7. Process Validation/Evaluation 工艺验证/评价.................................................................................................... 24
7.1 General Principles 总则............................................................................................................................. 24
3.1 General Principles 总则............................................................................................................................... 4 3.1.1 Drug Substance Quality Link to Drug Product 原料药质量与制剂产品的联系 ............................ 4 3.1.2 Process Development Tools 工艺开发工具 ..................................................................................... 5 3.1.3 Approaches wenku.baidu.como Development 开发方法 ............................................................................................ 5 3.1.4 Drug Substance Critical Quality Attributes 原料药关键质量属性（CQA） ................................. 7 3.1.5 Linking Material Attributes and Process Parameters to Drug Substance CQAs 物料属性及工艺参 数与原料药关键质量属性的联系............................................................................................................ 8 3.1.6 Design Space 设计空间 .................................................................................................................. 10
Page 1 of 45
ICH Q11 原料药开发和制造
中英对照
6.1.1 Approaches to Developing a Control Strategy 开发控制策略的方法 ........................................... 21
6.1.2 Considerations in Developing a Control Strategy 开发控制策略的考虑事项 .............................. 22
5.1 General Principles 总则............................................................................................................................. 16 5.1.1 Selection of Starting Materials for Synthetic Drug Substances 化学合成原料药起始物料的筛选
4. Description of Manufacturing Process and Process Controls 制造工艺描述与工艺控制 ................................. 15 5. Selection of Starting Materials and Source Materials 起始物料筛选及物料来源 ............................................. 16
ICH Q11 原料药开发和制造
中英对照
DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL
ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES)
Q11
Current Step 4 version dated 1 May 2012
TABLE OF CONTENTS
1. Introduction 介绍................................................................................................................................................... 3 2. Scope 范围............................................................................................................................................................. 4 3. Manufacturing Process Development 制造工艺开发 ........................................................................................... 4
................................................................................................................................................................. 16 5.1.2 Selection of Starting Materials for Semi-Synthetic Drug Substances 半合成原料药起始物料的筛 选 ............................................................................................................................................................. 18 5.1.3 Selection of Source and Starting Materials for Biotechnological/Biological Drug Substances 生物 技术/生物制品起始物料的选择............................................................................................................. 18 5.2 Submission of Information for Starting Material or Source Material 起始物料或物料来源的信息申报 19 5.2.1 Justification of Starting Material Selection for Synthetic Drug Substances 合成原料药起始物料的 选择依据 ................................................................................................................................................. 19 5.2.2 Justification of Starting Material Selection for Semi-Synthetic Drug Substances 半合成原料药起 始物料的选择依据.................................................................................................................................. 20 5.2.3 Qualification of Source or Starting Materials for Biotechnological/Biological Drug Substances 生 物技术/生物制品原料药源物料或起始物料源物料的确认................................................................. 20 6. Control Strategy 控制策略 .................................................................................................................................. 21 6.1 General Principles 总则............................................................................................................................. 21
6.2 Submission of Control Strategy Information 控制策略信息的申报 ........................................................ 23
7. Process Validation/Evaluation 工艺验证/评价.................................................................................................... 24
7.1 General Principles 总则............................................................................................................................. 24