ich-Q10（中英⽂对照）
P HARMACEUTICAL Q UALITY
S YSTEM Q10
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 SYSTEM1．制药质量体系
1.1 Introduction 1．1绪论
1.2 Scope 1．2范围
1.3 R elationship 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
白鹅教学设计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
香港红磡
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 RESPONSIBILITY2．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
柏拉图分析法
2.6 Management Review 2．6管理评审
2.7 Management of Outsourced Activities and
Purchad Materials
梦到上课
2．7外包活动和物料采购的管理金银岛简介
亚洲濒临的大洋
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 L ifecycle 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
什么英文怎么写的
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 M anagement Review of the Pharmaceutical
Quality System
4．1制药质量体系的管理评审
4.2 Monitoring of Internal and External Factors
Impacting the Pharmaceutical Quality System
4．2制药质量体系的内外部影响因素的监控
4.3 O utcomes of Management Review and
Monitoring
4．3管理评审和监控成果
5. GLOSSARY5．术语
Annex 1:Potential Opportunities to Enhance Science and Risk Bad 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
P HARMACEUTICAL Q UALITY S YSTEM制药质量体系
1. PHARMACEUTICAL QUALITY SYSTEM1．制药质量体系1.1 Introduction 1．1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 term “pharmaceutical quality system” re fers 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 bad on International 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 throughout 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. Conquently, the content of ICH Q10 that 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 authorities’ 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 link between pharmaceutical development and manuf
acturing 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 Scope1．2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。
红烧牛肉的做法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 (e Section 3). ICH Q10要素的应⽤需与产品⽣命周期的各个阶段相适应，应认识到和个阶段⽬标的差异（见第3节）。
For the purpos of this guideline, the product lifecycle includes the following technical activities for new and existing products: 本指南中，新⽼产品的产品⽣命周期包括如下的技术活动：
Pharmaceutical Development:
●Drug substance development;
●Formulation development (including
container/closure system);
●Manufacture of investigational products;
●Delivery system development (where relevant);
●Manufacturing process development and scale-up;
●Analytical method development. 药物研发：
●药⽤物质的研发
●配⽅研发（包括容器/密闭系统）●研究⽤产品的⽣产
●给药系统研发（如相关的话）
●⽣产⼯艺开发和放⼤
●分析⽅法开发
Technology Transfer:
●New product transfers during Development through Manufacturing;
●Transfers within or between manufacturing and testing sites for marketed products.
技术转移
●新产品从研发转移⾄⽣产
●市售产品⽣产和检测地点内部或之间转移
Commercial Manufacturing:
●Acquisition and control of materials;
●Provision of facilities, utilities, and equipment;
●Production (including packaging and labelling);
●Quality control and assurance;
●Relea;
●Storage;
●Distribution (excluding wholesaler activities). 商业化⽣产
●原料的获得和控制
●⼚房，公⽤设施和设备的准备●⽣产（包括包装和贴签）
●质量控制和保证
●放⾏
●储存
●发放（不包括批发商活动）
Product Discontinuation:
●Retention of documentation;
●Sample retention;
●Continued product asssment and reporting. 产品终⽌
●⽂件保留
●留样
●产品持续评估和报告
1.3 Relationship of ICH Q10 to Regional GMP
Requirements, ISO Standards and ICH Q7 1．3 ICH Q10与地区GMP要求，ISO标准及ICH Q7之间的关系
Regional GMP requirements, the ICH Q7 Guideline, “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, and ISO quality management system guidelines form the foundation for ICH Q10. To meet the objectives described below, ICH Q10 augments GMPs by describing specific
quality system elements and management responsibilities. ICH Q10 provides a harmonid model for a pharmaceutical 地区GMP要求，ICH Q7及ISO质量管理体系是是ICH Q10的基础。为了满⾜下述⽬的，ICH Ｑ１０通过叙述具体的质量体系要素和管理职责加强了ＧＭＰ。ＩＣＨＱ１０为产品⽣命周期的制药质量体系提供了⼀致的模型并预期与地区的ＧＭＰ要求⼀同使⽤。
quality system throughout the lifecycle of a product and is intended to be ud together with regional GMP requirements. The regional GMPs do not explicitly address all stages of the product lifecycle (e.g., Development). The quality system elements and management responsibilities described in this guideline are intended to encourage the u of science and risk
bad approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle. 地区的ＧＭＰ没有明确列出产品⽣命周期的所有阶段（如，研发）。此指南描述的质量体系基础和管理职责⽤于⿎励在每个⽣命周期阶段使⽤科学和风险管理⽅法，因⽽在全部的产品⽣命周期中促进持续改进。
1.4 Relationship of ICH Q10 to Regulatory
Approaches
1.4 ICH Q10和法规⽅法的关系
Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and process understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system. When implemented, the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site. Potential opportunities to enhance science and risk bad regulatory approaches are identified in Annex 1. Regulatory process will be determined by region. 特定产品或⽣产车间的法规⽅法应与产品和⼯艺的理解⽔平，质量风险管理结果和制药质量体系效果相对应。⼀旦实施，制药质量体系的有效性⼀般会在⽣产现场的官⽅审计过程中得到评价。基于法规⽅法对科学和风险进⾏改进的潜在机会如附件１所⽰。法规程序由各地区确定。
1.5 ICH Q10 Objectives 1.5 ICH Q10⽬的
Implementation of the Q10 model should result in achievement of three main objectives which complement or enhance regional GMP requirements. Ｑ１０模型的执⾏应该导致三个主要⽬标的完成，补充或提升地区ＧＭＰ要求。
1.5.1 Achieve Product Realisation 1.5.1 获得产品实现
To establish, implement and maintain a system that allows the delivery of products with the quality at
tributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approved regulatory filings) and other internal and external customers. 建⽴，实施和维护⼀体系以允许产品的交付合适地满⾜患者，保健专业⼈员，药政机构（包括符合批准的法规）和其它内部和外部的顾客。
1.5.2 Establish and Maintain a State of Control 1.5.2控制状态的建⽴和实现
To develop and u effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of process. Quality risk management can be uful in identifying the monitoring and control systems. 开发和使⽤⼯艺性能和产品质量的有效监控和控制体系，以此为⼯艺持续适宜性和性能提供保证。质量风险管理有助于监控和控制体系的确定。
1.5.3 Facilitate Continual Improvement 1.5.3 有助于持续改进
To identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancements, thereby increasing the ability to fulfil quality needs consistently. Quality risk management can be uful for identifying and prioritising areas for continual improvement. 确定和实施适宜的产品质量改进，⼯艺改
进，变动减少，创新和制药质量体系改进，以此提⾼持续满⾜需求的能⼒。质量风险管理有助于改进领域的确定和优先排序。
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
U of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. The enablers will facilitate achievement of the objectives described in Section 1.5 above by providing the means for science and risk bad decisions related to product quality. 知识管理和质量风险管理的使⽤将使公司有效并顺利地执⾏ICH Q10。它们有助于实现上述1.5章节所述的⽬的，为与产品质量相关的基于科学和风险的决定提供⽅法。
1.6.1 Knowledge Management 1．6．1知识管理
Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge manag
ement is a systematic approach to acquiring, analysing, storing and disminating information related to products, manufacturing process and components. Sources of knowledge include, but are not limited to prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities. 产品和⼯艺知识管理应从开发⼀直到产品的商业⽣命，并包括产品终⽌。⽐如，研发活动通过科学的⽅法为产品和⼯艺理解提供知识。知识管理是获得，分析，保存和公布产品制造，⼯艺和
