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1、Page 1 of 28 PHARMACEUTICAL QUALITY SYSTEMQ10 制药质量体系制药质量体系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 目录目录 1. PHARMACEUTICAL QUALITY SYSTEM 1制药质量体系制药质量体系 1.1 Introduction 11绪论 1.2 Scope 12范围 1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards
2、 and ICH Q7. 13ICHQ10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 14ICHQ10与法规方法间的关系 1.5 ICH Q10 Objectives 15ICHQ10目的 1.5.1 Achieve Product Realization 151产品实现 1.5.2 Establish and Maintain a State of Control 152控制状态的建立和实现 1.5.3 Facilitate Continual Improvement 153
3、持续改进 1.6 Enablers: Knowledge Management and Quality Risk Management 16支持者：知识管理和质量风险管理 1.6.1 Knowledge Management 161知识管理 1.6.2 Quality Risk Management 162质量风险管理 1.7 Design and Content Considerations 17设计和内容方面的考虑 1.8 Quality Manual 18质量手册 2. MANAGEMENT RESPONSIBILITY 2管理职责管理职责 2.1 Management Commitme
4、nt 21管理承诺 2.2 Quality Policy 22质量方针 2.3 Quality Planning 23质量策划 2.4 Resource Management 24资源管理 2.5 Internal Communication 25内部沟通 2.6 Management Review 26管理评审 2.7 Management of Outsourced Activities and Purchased Materials 27外包活动和物料采购的管理 2.8 Management of Change in Product Ownership 28产品所有权变更管理 3. CO
5、NTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY 3工艺性能和产品质量的持续改进工艺性能和产品质量的持续改进 3.1 Lifecycle Stage Goals 31生命周期阶段目标 3.1.1 Pharmaceutical Development 311物料研发 3.1.2 Technology Transfer 312技术转移 3.1.3 Commercial Manufacturing 313商业化生产 3.1.4 Product Discontinuation 314产品终止 3.2 Pharmaceutica
6、l Quality System Elements 32制药质量体系原理 Page 2 of 28 3.2.1 Process Performance and Product Quality Monitoring System 321工艺性能和产品质量监控体系 3.2.2 Corrective Action and Preventive Action (CAPA) System 322纠正预防体系 3.2.3 Change Management System 323变更管理体系 3.2.4 Management Review of Process Performance and Product
7、 Quality 324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制药质量体系的持续改进 4.1 Management Review of the Pharmaceutical Quality System 41制药质量体系的管理评审 4.2 Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System 42制药质量体系的内外部影响因素的监控 4.
8、3 Outcomes of Management Review and Monitoring 43管理评审和监控成果 5. GLOSSARY 5术语术语 Annex 1:Potential Opportunities to Enhance Science and Risk Based Regulatory Approaches 附件1：基于法规方法对科学和风险进行改进的 潜在机会 Annex 2:Diagram of the ICH Q10 Pharmaceutical Quality System Model 附件2：ICH Q10 制药质量体系模型图 Page 3 of 28 PHARMA
9、CEUTICAL QUALITY SYSTEM 制药质量体系制药质量体系 1. PHARMACEUTICAL QUALITY SYSTEM 1制药质量体系制药质量体系 1.1 Introduction 11绪论绪论 This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Qualit
10、y System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10 model. 本文确立了新的ICH三方指南， 叙述了制药工业 有效质量管理体系的一个模型， 被称之为制药质 量体系。在这个指南中，术语“制药质量体系” 是指ICH Q10模型。 ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on Inter
11、national Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughou
12、t the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 tha
13、t is additional to current regional GMP requirements is optional. ICHQ10叙述了基于ISO质量概念的有效的制 药管理体系的综合模型，包括了适用的GMP法 规，并与ICH Q8（药物研发）和ICH Q9（质 量风险管理）相辅相成。ICH Q10这一制药质 量体系模型是可以应用于产品生命周期的各个 阶段的。ICH Q10目的不在于创立超越现行法 规要求的新期望。因此，ICH Q10中多于现行 的各地的GMP要求的内容是可选的。 ICH Q10 demonstrates industry and regulatory author
14、ities support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the lin
15、k between pharmaceutical development and manufacturing activities. ICH Q10论述了行业和药政管理机构为了公众 健康而对有效制药质量体系的支持以提高世界 范围内药品的质量和获得性。 在整个产品生命周 期内实施了ICH Q10有助于创新和持续改进， 并加强了药物研发和生产活动间的联系。 1.2 Scope 12范围范围 This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug s
16、ubstances (i.e., API) and drug products, including biotechnology and biological products, throughout the product lifecycle 本指南适用于药用物质（API）和制剂的研发和 生产系统， 包括生物技术和生物产品的整个产品 生命周期。 Page 4 of 28 The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each stage (see Section 3). ICH Q10要素的应用需与产品生命周
