ich-Q10 中英
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
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 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
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 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
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 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
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 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 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. 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 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 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。
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 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;
●Release;
●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 assessment 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 harmonised 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 used 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 use of science and risk based 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 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 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 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，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 management 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 reduction, 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 described 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 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 disseminating 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 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 Management 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 product 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) 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 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 company’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 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 system 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 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 management 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 (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。
quality system.
1.8 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 system 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 maintain 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 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, monitoring 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 and 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 the 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，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) Commit 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 expectation 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 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 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 continually 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) Management 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) Communication 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 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 management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials. These processes should incorporate quality risk management and include: 制药质量体系，包括本章节中所叙述的管理职责，应拓展至外包活动和采购物料的质量的迫近和回顾。制药公司负责保证有程序来确保外包活动和采购物料的质量的控制。这些程序应与质量风险管理结合并包括：
(a) Assessing prior to outsourcing operations or selecting material suppliers, the suitability and competence of the other party to carry out the activity or provide the material using a defined supply chain (e.g., audits, material evaluations, qualification); (a)在外包或选择物料供应商前评估其它方开展这个活动或使用定义的供应链提供物料的适宜性和能力（如，审核，物料评价，确认）
(b) Defining the responsibilities and communication processes for quality-related activities of the involved parties. For outsourced activities, this should be included in a written agreement between the contract giver and contract acceptor; (b)定义相关方与质量有关的活动的职责和沟通程序。对于外包活动，承包人与要约人应当有一个书面的协议
(c) Monitoring and review of the performance of the contract acceptor or the quality of the material from the provider, and the identification and implementation of any needed improvements; (c)监控并回顾承包人的表现或供应商的物料进行，并对任何需要的改进进行确认和执行
(d) Monitoring incoming ingredients and materials to ensure they are from approved sources using the agreed supply chain. (d)监控引入的成分和物料，确保它们通过协议的供应链来源于已批准的来源
2.8 Management of Change in Product Ownership 2．8产品所有权变更管理
When product ownership changes, (e.g., through acquisitions) management should consider the complexity of this and ensure: 产品所有权变更时，管理层应当考虑复杂性并保证
(a) The ongoing responsibilities are defined for each
company involved;
(a)定义参与的每个公司的职责
(b) The necessary information is transferred. (b)转移必要的信息
3. CONTINUAL IMPROVEMENT OF PROCESS
PERFORMANCE AND PRODUCT QUALITY
3．工艺性能和产品质量的持续改进
This section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10objectives, as defined in Section 1.5. It does not restate all regional GMP requirements. 本章节叙述了生命周期阶段目标和四个具体的制药质量体系要素，它们强化了地区要求，以达到ICH Q10的目的，如1.5章节定义的。并不是重新叙述所有区域的GMP要求
3.1 Lifecycle Stage Goals 3．1 生命周期阶段目标
The goals of each product lifecycle stage are described
below.
产品生命周期的各个阶段的目标叙述如下：3.1.1 Pharmaceutical Development 3．1．1药物研发
The goal of pharmaceutical development activities is to design a product and its manufacturing process to consistently deliver the intended performance and meet the needs of patients and healthcare professionals, and regulator y authorities and internal customers’ requirements. Approaches to pharmaceutical development are described in ICH Q8. The results of exploratory and clinical development studies, while outside the scope of this guidance, are inputs to pharmaceutical development.药物研发活动的目标是设计产品及其制造工艺以持续提供预期的性能和满足患者,保健专家,药政机构和内部客户的需求。ICH Q8叙述了药物研发的方法。探索性研究和临床开发的结果不在本指南的范围内，但将用于药物开发。
3.1.2 Technology Transfer 3．1．2技术转移
The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement. 技术转移活动的目标是将产品和工艺知识在生产厂区内或之间从开发转移到生产以达到产品实现。这种知识是生产工艺，控制战略，工艺验证方法和持续改进的基础。
3.1.3 Commercial Manufacturing 3．1．3商业化生产
The goals of manufacturing activities include achieving product realisation, establishing and maintaining a state of control and facilitating continual improvement. The pharmaceutical quality system should assure that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded. 生产活动的目标包括达到产品实现，建立和维持控制状态及促进持续改进。制药质量体系应确保能经常达到理想的产品质量，能获得适宜的工艺性能，控制系列是合适的，确定并评价改进机会，且知识能持续拓展。
3.1.4 Product Discontinuation 3．1．4产品终止
The goal of product discontinuation activities is to manage the terminal stage of the product lifecycle effectively. For product discontinuation, a pre-defined approach should be used to manage activities such as retention of documentation and samples and continued product assessment (e.g., complaint handling and stability) and reporting in accordance with regulatory requirements. 产品终止活动的目标是有效地管理产品生命周期的最后阶段。关于产品终止，应采取事先确定的方法管理诸如文件保存，留样和延续性产品评估（比如，投诉处理和稳定性）及根据法规要求进行报告。
3.2 Pharmaceutical Quality System Elements 3．2制药质量体系要素
The elements described below might be, required in part under regional GMP regulations. However, the Q10 mod el’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: 地区GMP法规可能要求下列的要素。然而，Q10模型的目的是为了提升产品质量的生命周期方法而加强这些要素。四个要素是：
Process performance and product quality monitoring system;
Corrective action and preventive action (CAPA) system;
Change management system;
?Management review of process performance and product quality. 工艺性能和产品质量监控体系
纠正预防措施体系（CAPA）
变更管理体系
工艺性能和产品质量的管理评审
These elements 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. 适当并按比例地将这些要素应用于产品生命周期的各个阶段，认识到各个阶段的差异和不同的目标。
Throughout the product lifecycle, companies are encouraged to evaluate opportunities for innovative approaches to improve product quality. 在产品的生命周期中，鼓励公司评价改进产品质量的创新方法的机会。
Each element is followed by a table of example applications of the element to the stages of the pharmaceutical lifecycle. 每个要素按药物生命周期的各个阶段要素的应用实例的表格进行。
3.2.1 Process Performance and Product Quality
Monitoring System
3．2．1工艺性能和产品质量监控系统
Pharmaceutical companies should plan and execute a system for the monitoring of process performance and product quality to ensure a state of control is maintained. An effective monitoring system provides assurance of the continued capability of processes and controls to produce a product of desired quality and to identify areas for continual improvement. The process performance and product quality monitoring system should: 制药企业应规划和执行工艺性能和产品质量监控体系以确保控制状态得到了维持。有效的监控体系保证了持续性工艺性能和控制，以生产出需要的质量的产品和确定持续改进的范畴。工艺性能和产品质量监控体系应：
(a) Use quality risk management to establish the control strategy. This can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated method sand frequency of monitoring and control. The control strategy should facilitate timely feedback / feedforward and appropriate corrective action and preventive action; (a)应用质量风险管理以建立控制策略，可以包括原料药及药用物质和组份相关参数与属性，设施和设备运行条件，过程控制，成品质量标准，及监控和控制的相关方法与频率。控制策略应促进及时反馈/前馈及适宜的纠正措施和预防措施。
(b) Provide the tools for measurement and analysis of parameters and attributes identified in the control strategy (e.g., data management and statistical tools); (b)提供控制策略中所确定参数与属性的衡量与分析工具，比如数据管理和统计工具
(c) Analyse parameters and attributes identified in the control strategy to verify continued operation within a state of control; (c)分析控制策略中所确定参数与属性以证实后续操作受控
(d) Identify sources of variation affecting process performance and product quality for potential continual improvement activities to reduce or control variation; (d)确定影响工艺性能和产品质量的变量，持续改进活动会减少或控制这些变量
(e) Include feedback on product quality from both internal and external sources, e.g., complaints, product rejections, non-conformances, recalls, deviations, audits and regulatory inspections and findings; (e)包括产品质量的内外部反馈，如投诉，产品否决，不合格，召回，偏差，审计和官方检查与发现
(f) Provide knowledge to enhance process understanding, enrich the design space (where established), and enable innovative approaches to process validation. (f)提供知识以增强工艺理解，丰富设计空间（如建立的话），并实现工艺验证的创新方法
Table I: Application of Process Performance and Product Quality Monitoring System throughout the Product Lifecycle
表1：工艺性能和产品质量监控在整个生命周期内的应用
3.2.2 Corrective Action and Preventive
Action (CAPA) System
3．2．2纠正预防措施体系
The pharmaceutical company should have a system for implementing corrective actions and preventive actions resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring.
A structured approach to the investigation process should be used with the objective of determining the root cause. The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9. CAPA methodology should result in product and process improvements and enhanced product and process understanding. 对于由调查研究投诉，产品否决，不合格，召回，偏差，审计，官方检查和发现，及工艺性能趋势和产品质量监控等而产生的纠正措施和预防措施，制药企业应有体系来执行这些措施。应运用结构化的调查研究方法来确定根本原因。调查研究的努力水平，正式程序和文件应与风险水平ICH Q9相当。CAPA系列方法应使产品和工艺得到提高，产品和工艺的理解得到加强。
Table II: Application of Corrective Action and Preventive Action System throughout the Product Lifecycle
3.2.3 Change Management System 3．2．3变更管理体系
Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change. In order to evaluate, approve and implement these changes properly, a company should have an effective change management system. There is generally a difference in formality of change management processes prior to the initial regulatory submission and after submission, where changes to the regulatory filing might be required under regional requirements. 革新，持续改进，工艺性能和产品质量监控及CAPA都会趋势变更。为了适宜地评估，批准和执行这些变更，公司应具有有效的变更管理体系。一般来说，注册文件递交前后的变更管理流程是有些区别的，需遵从区域法规的要求进行注册文件的变更。
The change management system ensures continual improvement is undertaken in a timely and effective manner. It should provide a high degree of assurance there are no unintended consequences of the change. 变更管理体系确保持续改进得到了及时有效的执行，并高度保证变更不会引发不期望的后果。
The change management system should include the following, as appropriate for the stage of the lifecycle: 变更管理体系应在生命周期的各个阶段包括如下：
(a) Quality risk management should be utilised to evaluate proposed changes. The level of effort and formality of the evaluation should be commensurate with the level of risk; (a)运用质量风险管理评估计划的变更。评估的努力程序与正式程序应与风险水平相当。
(b) Proposed changes should be evaluated relative to the marketing authorisation, including design space, where established, and/or current product and process understanding. There should be an assessment to determine whether a change to the regulatory filing is required under regional requirements. As stated in ICH
Q8, working within the design space is not (b)应根据相关的上市许可，设计空间（如建立的话），和/或现行产品和工艺理解对计划的变更进行评估。需通过评估确定是否需要根据区域要求进行注册文件的变更。如ICH Q8所述，设计空间内的变动不被认为是变更（从注册文件的角度来看）。但是从制药质量体系的立场来看，所有的变更均需根据公司的变更管理体系进行评估。
considered a change (from a regulatory filing perspective). However, from a pharmaceutical quality systems, and point, all changes should be evaluated by a company’s chang e management system;
(c) Proposed changes should be evaluated by expert teams contributing the appropriate expertise and knowledge from relevant areas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulatory Affairs and Medical), to ensure the change is technically justified. Prospective evaluation criteria for a proposed change should be set; (c)计划的变更应得到专家组的评估，专家组需具备相关范围（如，药物开发，生产，质量，法规事务和医学）专长和知识，以保证变更在技术上被证明是合理的。对计划的变更应设立预期的评价标准。
(d) After implementation, an evaluation of the change should be undertaken to confirm the change objectives were achieved and that there was no deleterious impact on product quality. (d)实施后，应对变更进行评估以证实达到了变更目的，且证实对产品质量无有害影响。
Table III: Application of Change Management System throughout the Product Lifecycle
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
Management review should provide assurance that process performance and product quality are managed over the lifecycle. Depending on the size and complexity of the company, management review can be a series of reviews at various levels of management and should include a timely and effective communication and escalation process to raise appropriate quality issues to senior levels of management for review.管理评审应保证在整个生命周期内工艺性能和产品质量得到了管理。根据公司的规模和复杂性，管理评审可以是不同管理层次的一系列回顾，且要有及时有效的沟通和上报流程以使质量问题能被合理地上报至管理高层并得到审核。
(a) The management review system
should include:
(a)管理评审体系应包括：
(1) The results of regulatory inspections and findings, audits and other assessments, and commitments made to regulatory authorities; (1)官方检查和发现，审计或其它评估的结果，对药政部门的承诺
(2) Periodic quality reviews, that can
include:
(2)周期性的质量回顾，它可以包括：
(i) Measures of customer satisfaction
such as product quality complaints and
recalls;
(i)客户满意度，如产品质量投诉和召回
(ii) Conclusions of process performance
and product quality monitoring;
(ii)工艺性能和产品质量监控的结果
(iii)The effectiveness of process and product changes including those arising from corrective action and preventive actions. (iii)工艺和产品变更的效果，包括所引起的纠正和预防措施
(3) Any follow-up actions from previous
management reviews.
(3)先前管理评审的跟踪活动
(b) The management review system should
identify appropriate actions, such as:
(b)管理评审体系应确定适宜的行动，比如：
(1) Improvements to manufacturing
processes and products;
(1)生产工艺和产品改进
(2) Provision, training and/or
realignment of resources;
(2)资源的供应，培训和/或重组
(3) Capture and dissemination of
knowledge.
(3)知识的获取和发布
Table IV: Application of Management Review of Process Performance and Product Quality throughout the Product Lifecycle
4. CONTINUAL IMPROVEMENT OF
THE PHARMACEUTICAL QUALITY
4.制药质量体系的持续改进
SYSTEM
This section describes activities that should be conducted to manage and continually improve the pharmaceutical quality system 本章节叙述了管理和持续改进制药质量体系所需开展的活动。
4.1 Management Review of the
Pharmaceutical Quality System
4．1制药质量体系的管理审核
Management should have a formal process for reviewing the pharmaceutical quality system on a periodic basis. The review should include: 管理要有正式的流程，定期地评审制药质量体系。评审应包括：
(a) Measurement of achievement of
pharmaceutical quality system objectives;
(a)衡量制药质量体系目标成果
(b) Assessment of performance indicators that can be used to monitor the effectiveness of processes within the pharmaceutical quality system, such as: (b)评估性能指标，这些指标能被用来监控制药质量体系内流程的效果，如：
(1) Complaint, deviation, CAPA and
change management processes;
(1)抱怨，偏差，CAPA和变更管理程序
(2) Feedback on outsourced activities; (2)外包活动的反馈
(3) Self-assessment processes including
risk assessments, trending, and audits;
(3)自评程序，包括风险评估，趋势，审计
(4) External assessments such as regulatory inspections and findings and customer audits. (4)外部评估，如官方检查和发现及客户审计
4.2 Monitoring of Internal and External
Factors Impacting the
Pharmaceutical Quality System
4．2制药质量体系内外部影响因素的监控Factors monitored by management can include: 管理监控因素可以包括：
(a) Emerging regulations, guidance and quality issues that can impact the Pharmaceutical Quality System; (a)凸显能影响制药质量体系的法规，指
南和质量问题
(b) Innovations that might enhance the
pharmaceutical quality system;
(b)可能提高制药质量体系的革新
(c) Changes in business environment and
objectives;
(c)经营环境和目标的变更
(d) Changes in product ownership. (d)产品所有权的变更
4.3 Outcomes of Management Review
and Monitoring
4．3管理评审和监控成果
The outcome of management review of the pharmaceutical quality system and monitoring of internal and external factors can include: 制药质量体系的管理评审及内外部因素监控成果可以包括：
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英文推荐信 模板： Dear ______ , ① It is my great pleasure to recommend _____ （要推荐的人）to you. ② During his/her graduate years he/she was my _____ . ③ As his/her ______ I found him/her ______ （介绍与此人的关系）。 ④ His/Her performa nee in the school years was outsta nding. ⑤ First, he/she had bee n and showed great tale nts in ____ . ⑥ In additi on, he/she has a very pleasa nt pers on ality. ⑦ He has developed a strong sense of _____ , and worki ng with him/her is always _____ . ⑧ I can state that he/she has all the qualities of bei ng _____ . （介绍此人的能力） ⑨ Therefore, I here recomme nd him/her to you with all my heart. ⑩ Should you favor him/her with a positi on in your compa ny/Should you accept him/her in your university ？I am sure that his/her future conduct/academic work will prove worthy of your con fide nee. I look forward to heari ng from you at the earliest possible mome nt. Yours sin cerely, Wang Lin Paral:写信目的推荐 1.I am writing to recommend to you ...2.I would like to recommend to you (3) .It is a great honor for me to recommend to you … Para2全面介绍 1. He majors in computer software. 2. He has been given the title of the “ excellent student ” 3.He has great pote ntial.
英语谚语大全(中英互译)
英语谚语大全（中英互译） 本文是关于英语谚语大全（中英互译），仅供参考，希望对您有所帮助，感谢阅读。 1、All beginnings are hard. 万事开头难。 2、A book is like a garden carried in the pocket. 书是随时携带的花园。 3、A friend is a second self. 朋友是第二个自我。 4、A candle lights others and consumes itself. 蜡烛照亮了别人，燃尽了自己。 5、All work and no play makes Jack a dull boy. 只工作而无娱乐会使人愚钝。 6、A good conscience is a continual feast. 白日不做亏心事，夜半敲门心不惊。 7、A good name is better than riches. 好名誉胜过有财富 8、A bad workman always blames his tools. 劣工咎器。 9、A snow year, a good year. 瑞雪兆丰年。 10、Act fairly by all men. 一视同仁。 11、A man can die but once. 人生只有一次死。 12、A match will set fire to a large building. 星星之火，可以燎原。
13、A miss is as good as a mile. 失之毫厘，差之千里。 14、A bad beginning makes a bad ending. 开头不好，结尾必糟。 15、A man can not spin and reel at the same time. 一心不能二用。 16、Adversity makes a man wise, not rich. 困难和不幸不能使人富有，却能使人聪明。 17、A word to the wise is enough. 聪明人不用细说。 18、A good beginning makes a good ending. 欲善其终 , 必先善其始。 19、After rain comes fair weather. 否极泰来。 20、A body without knowledge is like a house without a foundation. 人无知犹如房屋无基。 22、A door must be either shut or open. 门不关就得开，二者必居其一。 / 非此即彼。 23、A little body often harbors a great soul. 浓缩的都是精品。 24、A man can do no more than he can. 凡事只能量力而行。 25、A little of everything, and nothing at all. 样样皆通，样样稀松。 26、A picture is a poem without words. 画为无言诗。 27、A word spoken cannot be recalled. 一言说出，难以收回。
出国留学导师推荐信中英文范文
出国留学导师推荐信中英文范文 导读：本文是关于出国留学导师推荐信中英文范文，希望能帮助到您！ 出国留学导师推荐信中英文范文 To whom it may Concern, I am writing this letter to attest to paul’s skills in language and public relations. In the four years I have known him, I have been consistently impressed with his ability not only to negotiate complex ideas in other languages, but also to relate these things in a personable, conscientious fashion. His manner in these cases is both professional and personal, two qualities which I find particularly valuable in a professional setting. He has personally helped me in professional negotiation for everything from train tickets to contract information, and I have always been able to count on him. I first met paul in school, where he was a student at the university at which I taught. He was well-known to most of the westerners in town, who could call from different universities to ask for his help. Sometimes this help involved translation of professional documents, and sometimes it involved personal help in making phone calls. Many of these westerners continue to call him today, even though they live quite far away from him, because they have come to trust him very much. From this foundation in public relations paul has found positions in various professional
推荐信签字中文还是英文
竭诚为您提供优质文档/双击可除推荐信签字中文还是英文 篇一：推荐信英文签字 推荐信签名及打印指引推荐信确定后，打印和签名要求如下：打印之前要排版，也就是把打印范围调好，内容不要打印在抬头上。第一步：点击“文件”--“页面设置”，看到“页边距”，然后用尺子量一下你所要打印 的纸张，上下左右是几厘米，数字敲进去；第二步：看到“纸张”--纸张大小默认为a4，宽度和高度，你需要用尺子量一下，然 后把数字敲进去就可以了； 最后，点击确定就可以了。信纸需要有学校（推荐单位）的抬头，信封要有学校（推荐单位）的标志。签名时注意：信封的封口线处，信纸下面有推荐人名字的地方要签名(签在署名右边)。并且，信封的签名 要横跨过信封的封口线（合上封口写名字，上面一半下面一半），签完名信封不要封口。签名 最好签英文的拼音，信封和信纸的签名要保持一致。你
申请几个学校，每个推荐人就签几份。 具体可以参考下面的图例推荐信请按照学校（或单位）信纸的大小调整格式，打印成一页或两页均可（美观即可），并请推荐人在落款处用黑色签字笔签名（如图所示）。 推荐信用学校（或单位）的信封装好，在信封封口骑缝签名（如图所示），推荐人签完名 后不要封口。信封封口的签名要与推荐信里的签名一致，中文名或拼音均可。篇二：英文推荐信dearsirormadam, xingyaoluhasbeenmorethantheidealstudent.inordertoac hievethehighest gradesandmydeepestrespect,shehasdemonstratedoutstan dinglearningpotential andmaintainedaclearsenseofpurpose.ifyourschoolprogr amisseekingsuperiorcandidateswitharecordofachieveme nt, xingyaoluisanexcellentchoice.shehasconsistentlydemo nstratedanabilityto
英文标点符号翻译中英文对照
+ plus 加号；正号 - minus 减号；负号 ±plus or minus 正负号 ×is multiplied by 乘号 ÷is divided by 除号 ＝is equal to 等于号 ≠is not equal to 不等于号 ≡is equivalent to 全等于号 ≌is equal to or approximately equal to 等于或约等于号 ≈is approximately equal to 约等于号 ＜is less than 小于号 ＞is more than 大于号 ≮is not less than 不小于号 ≯is not more than 不大于号 ≤is less than or equal to 小于或等于号 ≥is more than or equal to 大于或等于号 % per cent 百分之… ‰per mill 千分之… ∞infinity 无限大号 ∝varies as 与…成比例 √(square) root 平方根 ∵since; because 因为 ∴hence 所以 ∷equals, as (proportion) 等于，成比例 ∠angle 角 ⌒semicircle 半圆 ⊙circle 圆 ○circumference 圆周 πpi 圆周率 △triangle 三角形 ⊥perpendicular to 垂直于 ∪union of 并，合集 ∩intersection of 交，通集 ∫the integral of …的积分 ∑(sigma) summation of 总和 °degree 度 ′minute 分 ″second 秒 ℃Celsius system 摄氏度 { open brace, open curly 左花括号 } close brace, close curly 右花括号 ( open parenthesis, open paren 左圆括号 ) close parenthesis, close paren 右圆括号() brakets/ parentheses 括号 [ open bracket 左方括号 ] close bracket 右方括号 [] square brackets 方括号 . period, dot 句号，点 | vertical bar, vertical virgule 竖线 & ampersand, and, reference, ref 和，引用 * asterisk, multiply, star, pointer 星号，乘号，星，指针 / slash, divide, oblique 斜线，斜杠，除号 // slash-slash, comment 双斜线，注释符 # pound 井号 \ backslash, sometimes escape 反斜线转义符，有时表示转义符或续行符 ~ tilde 波浪符 . full stop 句号 , comma 逗号 : colon 冒号 ; semicolon 分号 ? question mark 问号 ! exclamation mark (英式英语) exclamation point (美式英语) ' apostrophe 撇号 - hyphen 连字号 -- dash 破折号 ... dots/ ellipsis 省略号 " single quotation marks 单引号 "" double quotation marks 双引号 ‖ parallel 双线号 & ampersand = and ～swung dash 代字号 §section; division 分节号 →arrow 箭号；参见号
英汉互译在线翻译怎样实现
现在英语的重要性相信大家都是有所了解的，特别是外贸工作者对英语的重要性更是深有体会的。同时在学业学习的过程中我们也是会经常遇到一些英汉互译的问题的额，那么我们应该怎样在线实现英汉互译的问题呢？下面就一起来看一下吧。 步骤一：要在线实现英汉互译的问题，我们就需要通过浏览器搜索在线翻译，进入下面这个页面来帮助我们进行实现。 步骤二：通过浏览器进入在线翻译页面后，有两个选项一个是短句翻译的选项，中文150字以内，英文150词以内都支持进行翻译，适合零散短句，日常用语，商贸交流，邮件往来，地址信息等短文本的翻译。
步骤三：还有一个选项是文档翻译的选项，一次只支持翻译一个文档，所支持翻译的文档格式有一下几种：PDF、WORD文档中的图片、扫描件、图纸。但是背景模糊的纯图片无法进行翻译。 步骤四：了解完上面的两个选项后，我们就可以根据需要选择一个选项进入了，下面小编就选择短句翻译的选项，来为大家进行讲解。
步骤五：转入短句翻译的选项后，会出现两个文本框，我们需要在左边的文本框中输入需要进行翻译的语句。 步骤六：语句输入好后，在文本框的上方可以对一些翻译的选项设置，这样可以帮助我们更快的实现翻译。
步骤七：翻译选项设置好后，就可以通过选择开始翻译按钮，对短语进行翻译了。 步骤八：耐心等待短语翻译结束后，翻译结果会在右边的文本框中呈现，我们可以通过文本框上方的复制按钮对翻译后的结果进行复制粘贴，也可以直接通过鼠标选中进行复制粘贴。
英汉互译的实现方法，上面已经为大家分享过了，实现过程简单快速，生活中再遇到关于翻译的问题，就可以用这个方法来进行实现了。
英文推荐信 模板
To Whom It May Concern: I have had the distinct pleasure of having JianPing Ding as a student in my English classes and on my debate team for four years at Shanghai University of Finance & Economics (SUFE). JianPing has been more than the ideal student. In order to achieve the highest grades, he has demonstrated outstanding leadership and maintained a clear sense of purpose. The academics at SUFE are most challenging, and JianPing fulfilled most the requirements with the added challenge of honors and advanced courses. Jianping is an outstanding speaker and debater. He has won many awards on the speech and debate circuits. Success in these activities requires extensive research and persuasive skills. One of the requirements in my advanced class is to prepare lectures and guidance for the beginners. With JianPing’s superior knowledge and involvement in the subjects, he developed a strong sense of confidence with a charming attitude. Therefore, I could always depend on him to set the best example as an instructor. Since his classmates, my fellow teachers, and I will always hold him in the highest esteem, I sincerely recommend JianPing Ding as the ideal candidate for Keio University. Respectfully submitted,
中英文经典电影中英文互译
中英文经典电影台词中英文互译 中英文经典电影台词中英文互译 (1) 英文电影 (1) 中文电影 (9) 英文电影 1. "Frankly, my dear, I don't give a damn." Gone with the Wind, 1939 ―坦白说，亲爱的，我不在乎。‖——《乱世佳人》（1939年） 2. "I"m going to make him an offer he can't refuse." The Godfather, 1972 ―我要开出一个他无法拒绝的条件。‖——《教父》（1972年） 3. "You don't understand! I coulda had class. I coulda been a contender. I could've been somebody, instead of a bum, which is what I am." On the Waterfront, 1954 ―你不明白！我本可以进入上流社会。我本可以成为一个上进的人。我本可以当个有脸面的人物，而不是像 现在这样当个小混混。"‖——《码头风云》（1954年） 4. "Toto, I've got a feeling we're not in Kansas anymore." The Wizard of Oz, 1939 ―托托，我有一种感觉我们再也回不了家了。‖——《绿野仙踪》（1939年）5. "Here's looking at you, kid." Casablanca, 1942 ―孩子，就看你的了。‖——《卡萨布兰卡》（1942年） 6. "Go ahead, make my day." Sudden Impact, 1983
英汉互译在线翻译句子
如果只是遇见，不能停留，不如不遇见。 if we can only encounter each other rather than stay with each other,then i wish we had never encountered. 2 。宁愿笑着流泪，也不哭着说后悔。心碎了，还需再补吗？ i would like weeping with the smile rather than repenting with the cry, when my heart is broken, is it needed to fix? 3 。没有谁对不起谁，只有谁不懂得珍惜谁。 no one indebted for others, while many people dont know how to cherish others. 4 。命里有时钟需有命里无时莫强求you will have it if it belongs to you, whereas you dont kvetch for it if it doesnt appear in your life. 5 。当香烟爱上火柴时，就注定受到伤害when a cigarette falls in love with a match, it is destined to be hurt. 6。爱情??在指缝间承诺指缝…。在爱情下交缠。love ,promised between the fingers finger rift, twisted in the love 7。没有人值得你流泪，值得让你这么做的人不会让你哭泣。 no man or woman is worth your tears, and the one who is, won?t make you cry. 8 。记住该记住的，忘记该忘记的。改变能改变的，接受不能改变的。 remember what should be remembered, and forget what should be forgotten. alter what is changeable, and accept what is unchangeable. love is like a butterfly. it goes where it pleases and it pleases where it goes. 爱情就像 一只蝴蝶，它喜欢飞到哪里，就把欢乐带到哪里。 if i had a single flower for every time i think about you, i could walk forever in my garden. 假如每次想起你我都会得到一朵鲜花，那么我将永远在花丛中徜徉。 within you i lose myself, without you i find myself wanting to be lost again. 有了你，我迷失了自我。失去你，我多么希望自己再度迷失。每一个沐浴在 爱河中的人都是诗人。 look into my eyes - you will see what you mean to me. 看看我的眼睛，你会发现你对 我而言意味着什么。distance makes the hearts grow fonder. 距离使两颗心靠得更 近。 i need him like i need the air to breathe. 我需要他，正如我需要呼吸空气。 if equal affection cannot be, let the more loving be me. 如果没有相等的爱，那就让 我爱多一些吧。 love is a vine that grows into our hearts. 爱是长在我们心里的藤蔓。
博士生导师推荐信范文(中英文版)
博士生导师推荐信范文(中英文版) being a professor in shanghai finance and economics university, i had given six lectures to hua sheng as an auditing teacher when she studied accountancy there as her second major, and had been her supervisor when she worked as an intern in my credit rating company. she had listened to me so attentively that many of the cases we studied in class were applied to her work effectively. i was really impressed by hua sheng’s performance during her five-week internship. in order to be more competent in the field of credit rating, she volunteered to assume more tasks, and further offered to work overtime with other regular employees. however hard the tasks were, she always managed to fulfill them with flying colors. such devotion to her career even as an intern is rarely seen in her peers. as she had done well in her accounting major, with an average score of 85 for the core courses, in addition to her remarkable learning ability, hua sheng was capable of doing some of the basic businesses in the company, and thus understanding the know-how of accounting more profoundly. she visited and researched fifteen companies in all, big or small, home or abroad, within the
中英文互译
中英文翻译 EXW FCA FAS FOB CFR CIF CPT DAF DES DEQ DDU DDP Offer Offeror Offeree Invitation for offer Subject to our final confirmation Cross offer Withdrawal Revocability Counter-offer Acceptance Mail box rule Receive of the letter of acceptance rule Late acceptance Identified to the contract Shipping documents Sale by description Sale by sample Fundamental breach of contract Anticipatory breach Specific performance Breach of condition Breach of warranty Unconditionally appropriated to the contract Reserve the right of disposal To the order of the seller or his agent Sale on approval Floating cargo Quality to be considered as being about equal to the sample Sales by specification, grade or standard Fair average quality Sales by brand of trade mark
英文推荐信Reference Letter
Reference Letter Dear sir or madam, In my capacity as a doctor and professor of history at XX University,I am writing to recommend Miss Han Meimei for the master programme in sociology at Your University.During academic year 2014-2015,she was a student in Sociology department,where I found her very diligent and intelligent. I came to know Miss Han because she enrolled in my section for the History of Chinese Women course in March 2015.In the class,she is one of the most outstanding students.She dared to raise doubts about the contents of book and carried out the discussions about the struggling ways of Chinese women.At the semester final she earned a high grade,which should be “A” according to our grading system. Besides,I also found her good at other subjects.After class,she had personal talks with me several times.She displayed such a great interest in history that she visited the National Museum to know about social division of labor in ancient times.In my opinion,Miss Han has a potential in sociology,which can be further developed.In view of her previous achievements in this college,I am firmly convinced that Miss Han will make a successful graduate student. Meanwhile,she took part in some other activities which made her obtain different capabilities.For example,she took charge of the English and Chinese interview for overseas students,which made her know about the English level and disciplinary quality of applicants.What is worth mentioning is her personality:she is honest,reliable,responsible and mature.I strongly recommend this promising young girl and your favorable consideration and assistance to her will be very much appreciated. I am sure she has had sufficient prerequisite knowledge for the subject and she certainly has the ability to undertake the study.I recommend Miss Han without reservation and shall appreciate your favorable consideration of her application. Sincerely yours, Li Lei Department Head of XX University Doctor in History of Tianjin Normal University Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxx Tel:0086-1xxxxxxxxxxxx E-mail:xxxxxxxxxxxxxxx@https://www.360docs.net/doc/511991133.html,
研究生推荐信英文
研究生推荐信英文 研究生推荐信英文 篇一： 英文信 Ad d: *** Email: *** Tel:*** Letter of Remendation Dear Sir or Madam, At ____’s request, I am riting a personal ahievement statement for her. I am ver supportive of her appliation for our postgraduate program hih she seems ell suited for. As an professor at ___________ , I have a great pleasure of riting this letter sine I have seen man examples of her talent and have long been impressed b her intelligene and diligene. The ourse of _________I taught from September 201X to Ju l 201X aims to develop the students’ high mand of reading and riting skills. It equips students ith a large amount of voabular, strong business riting skills, effetive riting methods andprehensive understanding of business ontext. Oing to her talent for language and her persistene in English learning, Ms. ________ made remarkable advanes. She proved herself to be a promising student ith solid language skill and exellent adaptive abilit. To most Chinese, English riting is the most diffiult part. Hoever, it seems that Ms. _______ has the talent to flexibl use English and to use the good sentenes in various riting materials. In addition to that,