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1、Page 1 of 28P PHARMACEUTICALHARMACEUTICAL Q QUALITYUALITY S SYSTEMYSTEMQ10Q10制药质量体系制药质量体系Q10Q10Current Step 4 version dated 4 June 2008当前版本，2008年6月4日，第4步TABLETABLE OFOF CONTENTSCONTENTS目录目录1.1. PHARMACEUTICALPHARMACEUTICAL QUALITYQUALITY SYSTEMSYSTEM1 1制药质量体系制药质量体系1.1 Introduction11绪论 1.2 Scope12范围
2、1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards 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 Approaches14ICHQ10与法规方法间的关系1.5 ICH Q10 Objectives15ICHQ10目的1.5.1 Achieve Product Realization151产品实现1.5.2 Establish and Maintain a State of C
3、ontrol 152控制状态的建立和实现1.5.3 Facilitate Continual Improvement153 持续改进1.6 Enablers: Knowledge Management and Quality Risk Management16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 Management162质量风险管理 1.7 Design and Content Considerations17设计和内容方面的考虑 1.8 Quality Manual18质量手册 2.2. MA
4、NAGEMENTMANAGEMENT RESPONSIBILITYRESPONSIBILITY2 2管理职责管理职责 2.1 Management Commitment21管理承诺 2.2 Quality Policy22质量方针 2.3 Quality Planning23质量策划 2.4 Resource Management24资源管理 2.5 Internal Communication25内部沟通 2.6 Management Review26管理评审 2.7 Management of Outsourced Activities and Purchased Materials27外
5、包活动和物料采购的管理2.8 Management of Change in Product Ownership28产品所有权变更管理 3.3.CONTINUALCONTINUAL IMPROVEMENTIMPROVEMENT OFOF PROCESSPROCESS PERFORMANCEPERFORMANCE ANDAND PRODUCTPRODUCT QUALITYQUALITY3 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 Goals31生命周期阶段目标 3.1.1 Pharmaceutical Development311物料研发
6、3.1.2 Technology Transfer312技术转移 3.1.3 Commercial Manufacturing313商业化生产 3.1.4 Product Discontinuation314产品终止3.2 Pharmaceutical Quality System Elements32制药质量体系原理3.2.1 Process Performance and Product Quality 321工艺性能和产品质量监控体系Page 2 of 28Monitoring System3.2.2 Corrective Action and Preventive Action (CA
7、PA) System322纠正预防体系3.2.3 Change Management System323变更管理体系3.2.4 Management Review of Process Performance and Product Quality324工艺性能和产品质量的管理评审4.4. CONTINUALCONTINUAL IMPROVEMENTIMPROVEMENT OFOF THETHE PHARMACEUTICALPHARMACEUTICAL QUALITYQUALITY SYSTEMSYSTEM4 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 Revi
8、ew of the Pharmaceutical Quality System41制药质量体系的管理评审4.2 Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System42制药质量体系的内外部影响因素的监控4.3 Outcomes of Management Review and Monitoring43管理评审和监控成果5.5. GLOSSARYGLOSSARY5 5术语术语AnnexAnnex 1 1:Potential Opportunities to Enhance S
9、cience 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AnnexAnnex 2 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 28P PHARMACEUTICALHARMACEUTICAL Q QUALITYUALITY S SYSTEMYSTEM制药质量体系制药质量体系1.1. PHARMACEUTICALPHARMACEUTICAL QUALITYQUALITY SYST
10、EMSYSTEM1 1制药质量体系制药质量体系1.11.1 IntroductionIntroduction 1 11 1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 Quality System. Throughout this guideline, the te
11、rm “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 International Standards Organisation (ISO) quality c
12、oncepts, 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 throughout the different stages of a product lifecycle.
13、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 that is additional to current regional GMP require
14、ments 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 authorities support of an effective pharmaceutical qual
15、ity 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 link between pharmaceutical development and manufact
16、uring 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。1.21.2 ScopeScope1 12 2范围范围This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., API) and drug products, including biotechnology and biological products, throughout the product lifecycle本指南适用于
