ich-Q10(中英文对照).doc

PHARMACEUTICAL QUALITY SYSTEMQ10 制药质量体系Q10 Current Step 4 version dated 4 June 2008 当前版本，2008年6月4日，第4步 TABLE OF CONTENTS 目录 1. PHARMACEUTICAL QUALITY SYSTEM 1．制药质量体系 1.1 Introduction 1．1绪论 1.2 Scope 1．2范围 1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7. 1．3ICHQ10与地方GMP要求，ISO标准与ICHQ7之间的关系 1.4 Relationship of ICH Q10 to Regulatory Approaches 1．4ICHQ10与法规方法间的关系 1.5 ICH Q10 Objectives 1．5ICHQ10目的 1.5.1 Achieve Product Realization 1．5．1产品实现 1.5.2 Establish and Maintain a State of Control 1．5．2控制状态的建立和实现 1.5.3 Facilitate Continual Improvement 1．5．3 持续改进 1.6 Enablers: Knowledge Management and Quality Risk Management 1．6支持者：知识管理和质量风险管理 1.6.1 Knowledge Management 1．6．1知识管理 1.6.2 Quality Risk Management 1．6．2质量风险管理 1.7 Design and Content Considerations 1．7设计和内容方面的考虑 1.8 Quality Manual 1．8质量手册 2. MANAGEMENT RESPONSIBILITY 2．管理职责 2.1 Management Commitment 2．1管理承诺 2.2 Quality Policy 2．2质量方针 2.3 Quality Planning 2．3质量策划 2.4 Resource Management 2．4资源管理 2.5 Internal Communication 2．5内部沟通 2.6 Management Review 2．6管理评审 2.7 Management of Outsourced Activities and Purchased Materials 2．7外包活动和物料采购的管理 2.8 Management of Change in Product Ownership 2．8产品所有权变更管理 3. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY 3．工艺性能和产品质量的持续改进 3.1 Lifecycle Stage Goals 3．1生命周期阶段目标 3.1.1 Pharmaceutical Development 3．1．1物料研发 3.1.2 Technology Transfer 3．1．2技术转移 3.1.3 Commercial Manufacturing 3．1．3商业化生产 3.1.4 Product Discontinuation 3．1．4产品终止 3.2 Pharmaceutical Quality System Elements 3．2制药质量体系原理 3.2.1 Process Performance and Product Quality Monitoring System 3．2．1工艺性能和产品质量监控体系 3.2.2 Corrective Action and Preventive Action (CAPA) System 3．2．2纠正预防体系 3.2.3 Change Management System 3．2．3变更管理体系 3.2.4 Management Review of Process Performance and Product Quality 3．2．4工艺性能和产品质量的管理评审 4. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM 4．制药质量体系的持续改进 4.1 Management Review of the Pharmaceutical Quality System 4．1