ich-Q10(中英文对照)

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1、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

2、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 Improvem

3、ent 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．

4、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 Managemen

5、t 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

6、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

7、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制药质量体系的管理评审 4.2 Monitoring of Internal and External Factors

8、 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 Outcomes of Management Review and Monitoring 4．3管理评审和监控成果 5. GLOSSARY 5．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

9、Pharmaceutical Quality System Model 附件2：ICH Q10 制药质量体系模型图 PHARMACEUTICAL QUALITY SYSTEM 制药质量体系 1. PHARMACEUTICAL QUALITY SYSTEM 1．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 effec

10、tive quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality 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 de

11、scribes one comprehensive model for an effective pharmaceutical quality system that is based 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

12、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

13、any new expectations beyond current regulatory requirements. Consequently, 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

14、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 th

15、e product lifecycle should facilitate innovation and continual improvement and strengthen the link 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 1．2范围 This guid

16、eline 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。 The elements of ICH Q10 should

17、 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 purposes of this guideline, the product lifec

18、ycle 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: l Drug substance development; l Formulation development (including container/closure system); l Manufacture of investigational products; l Delivery syst

19、em development (where relevant); l Manufacturing process development and scale-up; l Analytical method development. 药物研发： l 药用物质的研发 l 配方研发（包括容器/密闭系统） l 研究用产品的生产 l 给药系统研发（如相关的话） l 生产工艺开发和放大 l 分析方法开发 Technology Transfer: l New product transfers during Development through Manufactur

20、ing; l Transfers within or between manufacturing and testing sites for marketed products. 技术转移 l 新产品从研发转移至生产 l 市售产品生产和检测地点内部或之间转移 Commercial Manufacturing: l Acquisition and control of materials; l Provision of facilities, utilities, and equipment; l Production (including packaging an

21、d labelling); l Quality control and assurance; l Release; l Storage; l Distribution (excluding wholesaler activities). 商业化生产 l 原料的获得和控制 l 厂房，公用设施和设备的准备 l 生产（包括包装和贴签） l 质量控制和保证 l 放行 l 储存 l 发放（不包括批发商活动） Product Discontinuation: l Retention of documentation; l Sample retenti

22、on; l Continued product assessment and reporting. 产品终止 l 文件保留 l 留样 l 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 fo

23、r 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 harmonised model for a

24、pharmaceutical quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements. 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，ICHＱ１０通过叙述具体的质量体系要素和管理职责加强了ＧＭＰ。ＩＣＨ　Ｑ１０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。 The regional GMPs do not explicitly a

25、ddress 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 use of science and risk based approaches at each lifecycle stage, thereby promoting continual improvement across the e

26、ntire 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 th

27、e 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 sit

28、e. Potential opportunities to enhance science and risk based regulatory approaches are identified in Annex 1. Regulatory processes 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

29、 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

30、system that allows the delivery of products with the quality attributes 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

31、，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 use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk man

32、agement can be useful 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 re

33、duction, innovations and pharmaceutical quality system enhancements, thereby increasing the ability to fulfil quality needs consistently. Quality risk management can be useful 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

34、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 Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. These enablers will facilitate achievement of the objectives describ

35、ed in Section 1.5 above by providing the means for science and risk based 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

36、 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 management is a systematic approach to acquiring, analysing, storing and dissemi

37、nating information related to products, manufacturing processes 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 produ

38、ct 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，工艺和组分相关信息的系统方法。知识来源包括，但不限于，先前知识（公共领域或内部文件），药物开发研究，技术转移活动，产品生命周期内的工艺验证，生产经验，持续改进和变更管理活动。 1.6.2 Quality Risk M

39、anagement 1．6．2质量风险管理 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and prod

40、uct quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. 质量风险管理是有效的制药质量体系的不可分割的部分。它能提供确定，科学评价和控制潜在质量风险的前摄性方法。它有助于产品生命周期内工艺性能和产品质量的持续改进。ICH Q9提供了用于制药质量不同方面的质量风险管理工具

41、的原则和例子。 1.7 Design and Content Considerations 1．7设计和内容方面的考虑点 (a) The design, organisation and documentation of the pharmaceutical quality system should be well structured and clear to facilitate common understanding and consistent application. (a)制药质量体系的设计，组织和文件应清晰，并有良好的结构，能有助于共识和持续应用。 (b) T

42、he elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the different goals and knowledge available for each stage. (b)ICH Q10要素的应用需与产品生命周期的各个阶段相适应，应认识到各个阶段的不同目标和有用的知识。 (c) The size and complexity of the comp

43、any’s activities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one. The design of the pharmaceutical quality system should incorporate appropriate risk management principles. While some aspects of the pharmaceutical quality system can

44、 be company-wide and others site-specific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level. (c)在开发新的制药质量体系或对现有体系进行改进时，应考虑到公司活动的规模和复杂性。制药质量体系的设计应适当地与风险管理原则相结合。当制药质量体系的有些方面是公司范围的而其它的是场地特定的，则制药质量体系效果一般来说应在场地这个水平上进行阐述。 (d) The pharmaceutical quality sy

45、stem should include appropriate processes, resources and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in Section 2.7. (d)制药质量体系应包括适当的工艺，资源和职责，按2.7章节描述的为外包活动和采购物料提供质量保证。 (e) Management responsibilities, as described in Section

46、2, should be identified within the pharmaceutical quality system. (e)制药质量体系中应确定第2章节中所叙述的管理职责。 (f) The pharmaceutical quality system should include the following elements, as described in Section 3: process performance and product quality monitoring, corrective and preventive action, change manage

47、ment and management review. (f)制药质量体系应包括第3章节所述的如下要素：工艺性能和产品质量监控，纠正和预防措施，变更管理和管理评审。 (g) Performance indicators, as described in Section 4, should be identified and used to monitor the effectiveness of processes within the pharmaceutical quality system. (g) 应当确认第4章节描述的性能指标，并用于监控制药质量体系内程序的有效性。 1.8

48、 Quality Manual 1．8质量手册 A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. The description should include: 应建立质量手册或相当的文件，质量手册应包括制药质量体系的叙述。叙述应包括 (a) The quality policy (see Section 2); (a)质量方针（见

49、章节2） (b) The scope of the pharmaceutical quality system; (b)制药质量体系的范围 (c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and interdependencies. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality sy

50、stem processes in a visual manner; (c)确定制药质量体系的程序，以及它们的顺序，联系和相互依赖性。流程图是有用的工具，能形象地描述制药质量体系的程序。 (d) Management responsibilities within the pharmaceutical quality system (see Section 2). (d)本文章节2中叙述制药质量体系管理职责。 2. MANAGEMENT RESPONSIBILITY 2．管理职责 Leadership is essential to establish and maintai

51、n a company-wide commitment to quality and for the performance of the pharmaceutical quality system. 领导力对于建立和维护公司范围内的质量承诺及制药质量体系的施行是必要的。 2.1 Management Commitment 2．1管理承诺 (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to

52、 achieve the quality objectives, and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the company. (a)最高领导对有效制药质量体系的运行负最终责任，以完成质量目标，这些作用，职责和权力应在整个公司内确定，沟通和执行。 (b) Management should: (b)管理应当： (1) Participate in the design, implementation, monit

53、oring and maintenance of an effective pharmaceutical quality system; (1)参与有效制药质量体系的设计，实施，监控和维护 (2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organisation; (2)给予支持制药质量体系以强力可见的支持，并确保其在整个组织内的执行 (3) Ensure a timely a

54、nd effective communication and escalation process exists to raise quality issues to the appropriate levels of management; (3)确保有及时有效的沟通和上报流程，能将质量问题呈报到适宜的管理级别。 (4) Define individual and collective roles, responsibilities, authorities and inter-relationships of all organisational units related to t

55、he pharmaceutical quality system. Ensure these interactions are communicated and understood at all levels of the organisation. An independent quality unit/structure with authority to fulfil certain pharmaceutical quality system responsibilities is required by regional regulations; (4)确定个人与集体作用，职责，

56、权力和与制药质量体系相关的所有组织单元的相互关系。确保这些相互关系在组织的各个层次内得到了确立和理解。地区法规要求需要有一个独立的质量单元/结构，能有权利履行一定的制药质量体系职责。 (5) Conduct management reviews of process performance and product quality and of the pharmaceutical quality system; (5)进行流程性能和产品质量的管理评审，及制药质量体系的管理评审。 (6) Advocate continual improvement; (6)支持持续改进 (7) C

57、ommit appropriate resources. (7)调拨合适的资源 2.2 Quality Policy 2．2质量方针 (a) Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality. (a)最高领导应建立质量方针，质量方针应叙述公司质量相关的整体意愿和方向 (b) The quality policy should include an expe

58、ctation to comply with applicable regulatory requirements and should facilitate continual improvement of the pharmaceutical quality system. (b)质量方针应包括符合可行法规要求的期望，并应用助于制药质量体系的持续改进 (c) The quality policy should be communicated to and understood by personnel at all levels in the company. (c)质量方针应被

59、公司内所有层次的人员沟通理解 (d) The quality policy should be reviewed periodically for continuing effectiveness. (d)质量方针应定期回顾以得到持续的效果 2.3 Quality Planning 2．3质量策划 (a) Senior management should ensure the quality objectives needed to implement the quality policy are defined and communicated. (a)最高管理应当保证执行

60、质量方针所需的质量目标的确定和沟通 (b) Quality objectives should be supported by all relevant levels of the company. (b)质量目标应得到公司所有相关层次的支持 (c) Quality objectives should align with the company’s strategies and be consistent with the quality policy. (c)质量目标应与公司的战略相结合，并与质量方针相一致 (d) Management should provide the

61、 appropriate resources and training to achieve the quality objectives. (d)管理层应当提供适宜的资源和培训以达到质量目标 (e) Performance indicators that measure progress against quality objectives should be established, monitored, communicated regularly and acted upon as appropriate as described in Section 4.1 of this

62、document. (e)根据质量目标衡量进程的性能指标应当要被建立，监控，定期沟通并起到适宜的如4 .1章节所述的作用。 2.4 Resource Management 2．4资源管理 (a) Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the pharmaceutical quality system and c

63、ontinually improve its effectiveness. (a)管理层应当确定和提供充足的合适资源（人员，资源，物质，设施和设备）以实施和维持制药质量体系，并能质疑地提高其效力。 (b) Management should ensure that resources are appropriately applied to a specific product, process or site. (b)管理层应当确保能源被适宜地应用于特定的产品，工艺或场地。 2.5 Internal Communication 2．5内部沟通 (a) Managemen

64、t should ensure appropriate communication processes are established and implemented within the organisation. (a)管理层应当确保并在组织内建立并实施了适宜的沟通流程。 (b) Communications processes should ensure the flow of appropriate information between all levels of the company. (b)沟通流程应确保公司内所有层次间的适宜信息流 (c) Communicat

65、ion processes should ensure the appropriate and timely escalation of certain product quality and pharmaceutical quality system issues. (c)沟通流程应确保产品质量和质量体系问题能及时并适当地上报。 2.6 Management Review 2．6管理评审 (a) Senior management should be responsible for pharmaceutical quality system governance through

66、management review to ensure its continuing suitability and effectiveness. (a)最高管理者应当通过管理评审来负责制药质量体系控制，以保证其持续适宜性和有效性。 (b) Management should assess the conclusions of periodic reviews of process performance and product quality and of the pharmaceutical quality system, as described in Sections 3 and 4. (b)管理层应当评估流程性能和产品质量定期回顾的结论，及制药质量体系定期回顾的结论，如第3和4章节所述。 2.7 Management of Outsourced Activities and Purchased Materials 2．7外包活动和采购物料的管理 The pharmaceutical quality system, including the managem