【翻译】PDA TR 60-3 工艺验证 - 生命周期方法,附录2:生物制药原料药生产.pdf
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PDA TR 60-3 Process Validation:A Lifecycle A roach Annex 2 :Biopharmaceutical Drug Substances Manufacturing PDA 技术报告60-3 工艺验证:生命周期方法 附录2 :生物制药原料药生产 目录
1.0 Introduction 引言 2 1.1 Purpose and Scope 目的和范围 3
2.0 Glossary of Terms 术语表 6 2.1 Abbreviations 12
3.0 Stage 1: Building and Capturing Process Knowledge —Process Design 第一阶段:建立和获取工艺知识-工艺
设计 13 3.1 Sequence of Activities Leading Up to Stage 2 – Process Performance Qualification第二阶段前的活动顺序 -工艺性能确认 15 3.2 Analytical Methods 分析方法 16 3.3 Risk Assessments 风险评估 19 3.4 Platform Technology Application during Development 开发过程中的平台技术应用 20 3.5 Quality Target Product Profile and Critical Quality Attribute Assignment 目标产品质量概况和关键质量属 性分配 21 3.6 Control Strategy 控制策略 24
4.0 Stage 2: Process Qualification 工艺确认 36 4.1 Readiness 准备就绪 37 4.2 Process Validation 工