TGAGMP中英对照
TABLE OF CONTENT 目录
CHAPTER 1 - QUALITY MANAGEMENT (1)
Principle (1)
Quality Assurance (1)
Good Manufacturing Practice for Medicinal products (GMP) (2)
Quality Control (3)
Product Quality Review (4)
Quality Risk Management (5)
CHAPTER 2 - PERSONNEL (7)
Principle (7)
General (7)
Key Personnel (7)
Training (9)
Personal Hygiene (9)
CHAPTER 3 - PREMISES AND EQUIPMENT (11)
Principle (11)
Premises (11)
General (11)
Production Area (11)
Storage Areas (13)
Quality Control Areas (13)
Ancillary Areas (14)
Equipment (14)
CHAPTER 4 - DOCUMENTA TION (15)
Principle (15)
General (15)
Documents required (16)
Specifications (16)
Specifications for starting and packaging materials (16)
Specifications for intermediate and bulk products (17)
Specifications for finished products (17)
Manufacturing Formula and Processing Instructions (17)
Packaging Instructions (18)
Batch Processing Records (18)
Batch Packaging Records (19)
Procedures and records (20)
Receipt (20)
Sampling (20)
Testing (21)
Other (21)
CHAPTER 5 - PRODUCTION (22)
Principle (22)
General (22)
Prevention of cross-contamination in production (23)
V alidation (24)
Starting materials (24)
Processing operations - Intermediate and bulk products (25)
Packaging materials (25)
Packaging operations (26)
Finished products (27)
Rejected, recovered and returned materials (28)
CHAPTER 6 - QUALITY CONTROL (29)
Principle (29)
General (29)
Good Quality Control Laboratory Practice (30)
Documentation (30)
Sampling (30)
Testing (31)
On-going Stability Programme (32)
CHAPTER 7 - CONTRACT MANUFACTURE AND ANALYSIS (35)
Principle (35)
General (35)
The Contract Giver (35)
The Contract Acceptor (36)
The Contract (36)
CHAPTER 8 - COMPLAINTS AND PRODUCT RECALL (38)
Principle (38)
Complaints (38)
Recalls (39)
CHAPTER 9 - SELF INSPECTION (40)
Principle (40)
CHAPTER 1 QUALITY MANAGEMENT质量管理PRINCIPLE 原则
The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels wi thin the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice, and thus Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the manufacturing authorisation and for the authorised person(s).
制造商生产的药品必须能满足药品本身的潜在用途，符合市场的要求并且对使用者不存在药品安全、质量和疗效方面的危险。客户与经销商的质量目标的实现不但是公司高级主管的职责，也是公司内各个阶层所有部门的职员应承担的义务。为确保质量目标的实现，必须包括有计划、能正确贯彻落实的质量保证体系，良好的生产操作规范以及相应的质量控制。必须有充足的文件证明与有效的监控。质量保证系统的所有工作必须得到充分保证包括能胜任的人员、适当的厂房、设备与设施。另外对制造商主管和被授权人员应当增加法律责任。
The basic concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products.
质量保证、良好的生产操作规范和质量控制，它们最基本的概念是有内在联系的。为了强调它们对药品生产和控制的关联性以及基本原理的重要性，在这儿分别对它们进行了阐述。
QUALITY ASSURANCE 质量保证
1.1 Quality Assurance is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.
质量保证是一个范围比较宽的概念，它覆盖了产品质量的个性和共性的所有要素。质量保证是为确保药品的预期用途而必须达到的质量要求，从而进行的所有有组织的活动。因此质量保证与良好的生产操作规范以及本规范范围以外的其它要素是一体化的。
The system of Quality Assurance appropriate for the manufacture of medicinal
products should ensure that:
药品制造商的合适的质量保证体系必须能确保以下几个方面：
i. medicinal products are designed and developed in a way that takes
account of the requirements of Good Manufacturing Practice ;
药品在设计和研发时就应当考虑到良好的生产操作规范与优良的实验室的要求；
ii. production and control operations are clearly specified and Good Manufacturing Practice adopted;
生产和控制方法以及所采用的GMP规范必须被清楚地描述；
iii. managerial responsibilities are clearly specified;
清楚描述管理职责；
iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
从产品的生产、供应以及恰当的原料与包装材料的使用都应当进行合理的安排；
v. all necessary controls on intermediate products, and any other in-process controls and validations are carried out;
对中间产品和所有的中间过程都必须进行控制和验证；
vi. the finished product is correctly processed and checked, according to the defined procedures;
根据程序正确地生产和检查成品；
vii. medicinal products are not sold or supplied before an authorised person has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of medicinal products;
每批产品必须得到被授权人员的确认，确认该产品符合客户以及相关要求之后才能进行产品的销售与供应；
viii. satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life;
满意的管理应当尽可能地包括药品的贮存、分销以及后来的使用，确保产品在有效期内的质量；
ix. there is a procedure for self-inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system.
企业必须有一个对质量保证体系的有效性和适宜性的定期评价，比如自检和/或质量审计。GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP) 良好的生产操作规范
1.2 Good Manufacturing Practice is that part of Quality Assurance which ensures that Medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation or product specification.
良好的生产操作规范是质量保证体系的一部分，它确保产品的质量符合它们潜在的用途并满足产品供应商以及产品规格的要求。
Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that:
良好的生产操作规范包括生产和质量控制。良好的生产操作规范最基本的要求有以下几个方面：
i. all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications;
必须详细说明所有的生产过程，根据经验系统地评估，并证明其能连续生产出符合质量和药品规范要求的药品；
ii. critical steps of manufacturing processes and significant changes to the process are validated;
对生产过程的关键步骤和生产过程中发生的重大变更必须进行验证；
iii. all necessary facilities for GMP are provided including:
所有的必备条件必须包括以下的内容：
a. appropriately qualified and trained personnel; 有资格的且经过培训的人员；
b. adequate premises and space; 适当的厂房与空间；
c. suitable equipment and services; 相匹配的设备与维修；
d. correct materials, containers and labels; 合格的原料，包装和标签；
e. approved procedures and instructions; 经批准的操作程序与生产指令；
f. suitable storage and transport; 适当的贮存与运输；
iv. instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;
用来指导生产的生产指令与操作规程语句必须明确，不得含糊，特别是针对那些在线使用的设备与设施；
v. operators are trained to carry out procedures correctly;
操作工人必须经过培训以便正确执行操作程序；
vi. records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated;
在生产指令与操作规程中规定的所有生产过程必须要有记录，如实地记录生产过程中所发生的一切，包括产品的数量与质量，任何一次有影响的偏离都必须要有完整的记载并进行调查。
vii. records of manufacture including distribution which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form;
生产以及销售记录必须能完全反映批生产的历史，以便追溯，记录的保存应便于查阅；
viii. the distribution (wholesaling) of the products minimises any risk to their quality;
产品的销售过程不能对质量产生影响；
ix. a system is available to recall any batch of product, from sale or supply;
召回系统对每批产品都必须是可行的；
x. complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent re-occurrence.
对已销售的产品的投诉必须进行调查，调查导致质量缺陷的原因，并针对原因采取适当的措施避免再次发生。
QUALITY CONTROL 质量控制
1.3 Quality Control is that part of Good Manufacturing Practice whic h is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
质量控制是良好的生产操作规范的一部分，它与取样、规格说明书和检测、组织机构、文件和产品的放行有关，质量控制确保使用的物料和销售的产品，只有经过必要的和相关的检测，质量符合要求后才能放行。
The basic requirements of Quality Control are that: 质量控制的基本要求是：
i. adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and
testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes;
足够的设施、经培训的人员和经批准的程序，取样、检查和检测起始物料、包装材料、中间体、散装物料和成品，以及根据GMP要求进行的环境监测等是适用的；
ii. samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control;
起始物料、包装材料、中间产品、散装物料和成品的取样必须由质量控制部门批准的人员采用经批准的方法完成；
iii. test methods are validated; 检测方法要经过验证；
iv. records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated;
所有能反映取样、检查和检测过程具体操作的手写的或自动生成的，都必须形成记录。所有偏离要有完整的记录并进行调查；
v. the finished products contain active ingredients complying with the qualitative and quantitative composition of the marketing authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled;
成品所包含的活性成分，其纯度必须在定性或定量上与市场的纯度要求相符，并使用合适的容器密封包装，贴上正确的标签；
vi. records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures;
物料、中间体、散装物料和成品的检查和检测结果所形成的记录，必须依据规格说明书进行评估。产品的评估包括相关生产文件的回顾和评价以及与程序相偏离的评估；
vii. no batch of product is released for sale or supply prior to certification by an authorised person that it is in accordance with the requirements of the relevant authorisations;
批产品在被授权人员证明符合市场要求之前，不允许放行销售，
viii. sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced.
必须保留足够的起始物料和产品的样品，以便以后必要时对产品进行检测，除非包装很大，产品必须留存在最终包装里。
PRODUCT QUALITY REVIEW 产品质量回顾
1.4 Regular periodic or rolling quality reviews of all licensed medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:
i. A review of starting materials including packaging materials used in the product, especially those from
new sources.
ii. A review of critical in-process controls and finished product results.
iii. A review of all batches that failed to meet established specification(s) and their investigation.
iv. A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken.
v. A review of all changes carried out to the processes or analytical methods.
vi. A review of Marketing Authorisation variations submitted/granted/ refused, including those for third country (export only) dossiers.
vii. A review of the results of the stability monitoring programme and any adverse trends.
viii. A review of all quality-related returns, complaints and recalls and the investigations performed at the time.
ix. A review of adequacy of any other previous product process or equipment corrective actions.
x. For new marketing authorisations and variations to marketing authorisations, a review of post-marketing commitments.
xi. The qualification status of relevant equipment and utilities, e.g. HV AC, water, compressed gases, etc.
xii. A review of any contractual arrangements as defined in Chapter 7 to ensure that they are up to date.
The manufacturer and marketing authorisation holder should evaluate the results of this review and an assessment made of whether corrective and preventative action or any revalidation should be undertaken. Reasons for such corrective actions should be documented. Agreed corrective and preventative actions should be completed in a timely and effective manner. There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures verified during self-inspection. Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid dosage forms, sterile products, etc. where scientifically justified.
Where the marketing authorisation holder is not the manufacturer, there should be a technical agreement in place between the various parties that defines their respective responsibilities in producing the quality review. The authorised person responsible for final batch certification together with the marketing authorisation holder should ensure that the quality review is performed in a timely manner and is accurate.
QUALITY RISK MANAGEMENT 质量风险管理
1.5 Quality risk management is a systematic process for the assessment, control, ommunication and review
of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.
1.6 The quality risk management system should ensure that:
- the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient;
- the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.
Examples of the processes and applications of quality risk management can be
found inter alia in Annex 20.
CHAPTER 2 PERSONNEL 人员
PRINCIPLE 原则
The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.
满意的质量保证体系的建立和维持以及药物的正确生产是依靠人来完成的。这就要求有足够的资质人员来完成企业的各项职能。人员必须清楚地了解每项职能，并形成记录。所有人员必须明白GMP的基本要求，并接受最初的和连续的培训，包括卫生指令以及它们的相关要求。
GENERAL 一般原理
2.1. The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.
企业必须要有足够的有实践经验的资质人员。产品质量的风险与每个人的责任相连。
2.2. The manufacturer must have an organisation chart. People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice.
企业必须提供组织机构图。负责人必须要有详细的工作职责的书面描述，并有足够的人员来完成他们的职责。他们的职责是满意的资质水平的代表。与GMP要求相关的各项职能之间必须没有缺口或重叠。
KEY PERSONNEL 关键人员
2.3. Key Personnel includes the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the release of products the authorised person(s) designated for the purpose. Normally key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other. In large organisations, it may be necessary to delegate some of the functions listed in 2.5., 2.6. and 2.7.
关键人员包括生产负责人、质量控制负责人或者至少他们当中的一个，关键人员不负责产品的放行，他们是为了指定目的而被授权的人员。通常关键人员必须由全职人员担任。生产负责人和质量控制负责人必须彼此独立。一个大的企业，一些必须的职能参见2.5、2.6和2.7。
2.4. ...
2.5. The head of the Production Department generally has the following responsibilities:
生产部门负责人通常有以下的职责：
i. to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;
为获得所要求的质量，必须确保根据适当的文件进行产品的生产和贮存；
ii. to approve the instructions relating to production operations and to ensure their strict implementation;
批准与生产有关的操作指令，并确保严格执行；
iii. to ensure that the production records are evaluated and signed by an authorised person before they are sent to the Quality Control Department;
生产记录在被送到质量控制部门前，确保被授权人员对生产记录进行复核和签名；
iv. to check the maintenance of his department, premises and equipment;
检查所负责的部门、厂房和设备的维护情况；
v. to ensure that the appropriate validations are done; 确保完成相关的验证；
vi. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
根据需要，确保本部门人员所必需的岗前培训和继续教育。
2.6. The head of the Quality Control Department generally has the following responsibilities:
质量控制部门负责人通常有以下的职责：
i. to approve or reject, as he sees fit, starting materials, packaging materials, and intermediate, bulk and finished products;
批准或拒绝起始物料、包装材料、中间体、散装产品或成品；
ii. to evaluate batch records; 审核批记录；
iii. to ensure that all necessary testing is carried out; 确保完成所有必需的检测；
iv. to approve specifications, sampling instructions, test methods and other Quality Control procedures;
对说明书、取样指令、检测方法和其它质量控制程序的批准；
v. to approve and monitor any contract analysts; 批准并监控所有合同分析；
vi. to check the maintenance of his department, premises and equipment; 检查所负责的部门、环境和设施的维护情况；
vii. to ensure that the appropriate validations are done; 确保相关验证的执行；
viii. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need. Other duties of the Quality Control Department are summarised in Chapter 6.
根据需要，确保本部门人员所必需的岗前培训和继续教育。质量控制部门的其它职责在第6章已有概述。
2.7. The heads of Production and Quality Control generally have some shared, or jointly exercised, responsibilities relating to quality. These may include, subject to any national regulations: 生产和质量负责人通常分担或共同承担与质量相关的一些职能。
.. the authorisation of written procedures and other documents, includingamendments;
书面程序和其它文件的认可，包括修订；
.. the monitoring and control of the manufacturing environment; 生产环境的监测和控制；
.. plant hygiene; 厂区卫生；
.. process validation; 生产验证；
.. training; 培训；
.. the approval and monitoring of suppliers of materials; 原料供应商的批准和监控；
.. the approval and monitoring of contract manufacturers; 合同供应商的批准和监控；
.. the designation and monitoring of storage conditions for materials and products;
物料和产品贮存条件的确定和监控；
.. the retention of records; 记录的保存；
.. the monitoring of compliance with the requirements of GMP; 对GMP要求符合性的监控； .. the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality. 对影响产品质量的原因进行检查、调研并取样分析。
TRAINING 培训
2.8. The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.
企业必须对所有进入生产区或控制实验室区域的人员(包括技术人员、维护人员和清洁人员)进行培训，包括其它对产品质量有影响的人员。
2.9. Beside the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.
除了GMP的理论和实践的基础培训外，还必须接受与人员职能相关的培训。必须进行继续教育，并定期进行培训效果的评价。培训程序必须是可行的，由生产负责人或质量控制负责人批准，培训记录必须保留。
2.10. Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training.
在易产生污染的生产区工作的人员必须进行专门的培训。例如洁净环境或高活性、有毒、易感染或敏感性物质的生产环境。
2.11. V isitors or untrained personnel should, preferably, not be taken into the production and Quality Control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.
参观或未经培训的人员不允许进入生产和质量控制区。如果不可避免时，进入前必须提前告诉他们相关信息，特别是个人卫生和工作服的穿戴。他们应在人员的指导下进入。
2.12. The concept of Quality Assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.
质量保证的观念和所有改进措施的理解和执行，必须在培训的过程中充分讨论。PERSONAL HYGIENE 个人卫生
2.1
3. Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management
and widely discussed during training sessions.
在工厂内必须根据不同的要求建立并采用详细的卫生程序。卫生程序必须包括与健康、卫生习惯和个人服饰相关的内容。程序必须被有权进入生产和质量控制区的每一个员工所理解并严格执行。卫生程序必须通过管理和培训充分讨论而不断改进。
2.14. All personnel should receive medical examination upon recruitment. It must be the manufacturer's responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacturer's knowledge. After the first medical examination, examinations should be carried out when necessary for the work and personal health.
所有人员必须进行健康检查。这是企业管理者的责任，并有相关指令确保与产品质量相关的健康要求能满足。在第一次健康检查以后，生产和人员健康对检查有需求时，仍必须进行。
2.15. Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.
必须采取措施，一直到能确保没有传染病患者或暴露在环境中的体表有伤口的人员从事药品的生产操作。
2.16. Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.
进入生产区的任何人必须穿戴与操作要求相适应的工作服。
2.17. Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected, should be forbidden.
在生产或贮存区必须禁止吃、喝、咀嚼或抽烟，或存放食物、饮料、香烟或私人药物。通常情况下，在生产区或其它对产品有影响的区域，必须禁止不良的卫生习惯。
2.18. Direct contact should be avoided between the operator's hands and the exposed product as well as with any part of the equipment that comes into contact with the products.
操作工的双手不允许直接接触产品或与产品接触的设备表面。
2.19. Personnel should be instructed to use the hand-washing facilities. 指导员工按规定使用洗手设施。
2.20. Any specific requirements for the manufacture of special groups of products, for example sterile preparations, are covered in the Supplementary Guidelines.
对特殊产品生产的特殊要求，例如灭菌，详见附录。
CHAPTER 3 PREMISES AND EQUIPMENT厂房与设备PRINCIPLE 原则
Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products.
厂房与设备的选址或选型、设计、建造、维护都必须与生产的要求相适应。设计和布局的要求是将错误的风险降低到最低，并易于清洁和维护以避免交叉污染、灰尘或污垢的积聚，基本要求是对产品的质量不能产生不良影响。
PREMISES 厂房
General 一般要求
3.1. Premises should be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products.
厂房必须坐落在合适的环境，厂房必须考虑如何便于采取措施对生产过程进行保护，使对物料和产品的污染的风险降低到最低。
3.2. Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, w here applicable, disinfected according to detailed written procedures.
厂房必须进行适当维护保养，并确保维护保养时不对产品的质量产生危害。厂房必须根据书面程序进行适当的清洁和消毒。
3.3. Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medic inal products during their manufacture and storage, or the accurate functioning of equipment.
必须采用合适的照度、温度、湿度和通风，使它们对药物的生产和贮存，或设备的正常性能，不产生直接或间接的影响。
3.4. Premises should be designed and equipped so as to afford maximum protection against the entry of insects or other animals. 厂房设计和安装时必须最大限度地防止昆虫或其它动物的进入。
3.5. Steps should be taken in order to prevent the entry of unauthorised people. Production, storage and quality control areas should not be used as a right of way by personnel who do not work in them.
必须采取措施阻止未经批准的人员进入厂区。生产、贮存和质量控制区域不允许非工作人员进入。
Production Area生产区
3.6. In order to minimise the risk of a serious medical hazard due to cross-contamination, dedicated and self-contained facilities must be available for the production of particular medicinal products, such as highly sensitising materials (e.g. penicillins) or biological preparations (e.g. from live micro-organisms). The production of certain additional products, such as certain antibiotics, certain hormones, certain cytotoxics, certain highly active drugs and non-medicinal products should not be conducted in the same facilities. For those products, in exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations are made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of medicinal products.
为了降低由于交叉污染而引起的严重药物危害的风险，专用以及自身所包含的设施必须对特殊药品的生产适用，例如高敏感性物料(如青霉素)或生物培养体(如来自活体微生物)。特殊产品的生产，比如抗生素、激素、细胞毒素、高活性药物以及非药物产品，不能在同一区域生产。对于这些产品必须有专门的生产区域，在同一区域的季节性生产是允许的，但要有详细的防范措施，并进行验证。像杀虫剂和除草剂等毒性药剂的生产不允许在药物生产区域进行。
3.7. Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels.
必须根据生产顺序以及洁净级别要求，对厂房进行合理的设计。
3.8. The adequacy of the working and in-process storage space should permit the orderly and logical positioning of equipment and materials so as to minimise the risk of confusion between different medicinal products or their components, to avoid cross-contamination and to minimise the risk of omission or wrong application of any of the manufacturing or control steps.
必须有足够的生产和中间体的贮存空间，使设备和物料能进行有序的合理布局，从而将不同药物或不同成分相互混淆的风险降低到最低，从而降低交叉污染以及生产和控制步骤的疏忽或错误的风险。
3.9. Where starting and primary packaging materials, intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors and ceilings) should be smooth, free from cracks and open joints, and should not shed particulate matter and should permit easy and effective cleaning and, if necessary, disinfection.
在起始物料、内包装材料、中间体或散装产品暴露的环境，其内表面(墙壁、地板和天花板)必须光滑，没有裂缝并衔接完好，没有颗粒物脱落并易于清洁，必要的时候进行消毒。
3.10. Pipe work, light fittings, ventilation points and other services should be designed and sited to avoid the creation of recesses which are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas.
管道、照明设施、通风口和其它设施的设计和安装必须易于清洁。为便于维护保养，尽可能地靠近生产区域的外面，
3.11. Drains should be of adequate size, and have trapped gullies. Open channels should be avoided where possible, but if necessary, they should be shallow to facilitate cleaning and disinfection.
必须有足够的地方排水，并有下水道。尽可能不设置敞口通道，必要的话也必须很浅以便于清洁和消毒。
3.12. Production areas should be effectively ventilated, with air control facilities (including temperature and, where necessary, humidity and filtration) appropriate both to the products handled, to the operations undertaken within them and to the external environment.
生产区域必须采用空气控制系统有效通风(包括温度，必要时湿度控制并进行过滤)，空气要求必须与生产要求和外部环境相适应。
3.13. Weighing of starting materials usually should be carried out in a separate weighing room designed for that use.
起始物料通常必须在单独的称重房内称量。
3.1
4. In cases where dust is generated (e.g. during sampling, weighing, mixing and processing operations, packaging of dry products), specific provisions should be taken to avoid cross-contamination and facilitate cleaning.
易产生粉尘的地方(例如取样、称重、混合和生产操作、干燥产品的包装)，必须采取措施避免交叉污染，并对设备进行清洁。
3.15. Premises for the packaging of medicinal products should be specifically designed and laid out so as to avoid mix-ups or cross-contamination.
药物的包装区域必须详细设计规划以避免药物混淆和交叉污染。
3.16. Productions areas should be well lit, particular ly where visual on-line controls are carried out.
生产区域必须有足够的照明，特别是通过视觉在线控制的地方。
3.17. In-process controls may be carried out within the production area provided they do not carry any risk for the production.
为防止产品产生任何风险，在生产区域有必要进行中间过程控制。
Storage Areas 贮存区
3.18. Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine, released, rejected, returned or recalled.
必须有足够的贮存区来保证不同种类的物料和产品的有序存放：起始物料和包装材料，中间体，散装产品和成品，待检品、合格品、不合格品、返工与召回产品。
3.19. Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.
仓储必须设计或改建得能确保良好的贮存条件。特别是贮存区必须清洁、干燥并维持在可接受的温度范围内。要求有特殊贮存条件的(例如温度、湿度)，企业必须提供，并进行检查和监控。
3.20. Receiving and dispatch bays should protect materials and products from the weather. Receptions areas should be designed and equipped to allow containers of incoming materials to be cleaned where necessary before storage.
接收区和分发区必须对物料和产品进行防护。对接收区的设计和安装必须考虑到，在贮存前对物料容器的清洁。
3.21. Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorised personnel. Any system replacing the physical quarantine should give equivalent security.
仓储的隔离区必须要有清楚的状态标识，并限制人员进出。任何系统的更换和隔离必须采取同等的安全措施。
3.22. There should normally be a separate sampling area for starting materials. If sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination. 通常对于起始物料要有单独的取样区。如果在仓储区取样，取样时必须防止污染或交叉污染。
3.23. Segregated areas should be provided for the storage of rejected, recalled or returned materials or products.
对不合格品、召回产品或返工的物料或产品必须专区存放。
3.2
4. Highly active materials or products should be stored in safe and secure areas.
高活性物料或产品必须贮存在安全可靠的地方。
3.25. Printed packaging materials are considered critical to the conformity of the medicinal products and special attention should be paid to the safe and secure storage of these materials.
已印制好的包装材料应当考虑到与药品的一致性，特别要注意的是包装材料贮存的安全可靠性。Quality Control Areas 质量控制区
3.26. Normally, Quality Control laboratories should be separated from production areas. This is particularly important for laboratories for the control of biologicals, microbiologicals and radioisotopes, which should also be separated from each other.
通常情况下，质量控制实验室必须与生产区域分开。这对生物体、微生物和放射性元素的实验室特别重要，它们必须彼此分开。
3.27. Control laboratories should be designed to suit the operations to be carried out in them. Sufficient space should be given to avoid mix-ups and cross-contamination. There should be adequate suitable storage space for samples and records.
实验室的设计必须与生产要求相适应。必须要有足够的地方避免混淆和交叉污染。对样品和记录足够的适宜的存放区。
3.28. Separate rooms may be necessary to protect sensitive instruments from vibration, electrical interference, humidity, etc.
对敏感性仪器必须提供单独的房间，防止震动、电磁干扰、潮湿等。
3.29. Special requirements are needed in laboratories handling particular substances, such as biological or radioactive samples.
处理特殊物质，实验室必须要有专门要求，例如生物体或放射性样品。
Ancillary Areas辅助区
3.30. Rest and refreshment rooms should be separate from other areas.
休息处和茶点室必须与其它区域分开。
3.31. Facilities for changing clothes, and for washing and toilet purposes should be easily accessible and appropriate for the number of users. Toilets should not directly communicate with production or storage areas.
对更换的工作服，清洗、洗手间的设施必须与使用的人员相适应。洗手间不能与生产区或贮存区直接相连。
3.32. Maintenance workshops should as far as possible be separated from production areas. Whenever parts and tools are stored in the production area, they should be kept in rooms or lockers reserved for that use.
维修车间必须与生产区域分开，并尽可能远离。在生产区域存放的零部件和工具，不使用时必须保留在专门房间内并上锁。
3.33. Animal houses should be well isolated from other areas, with separate entrance (animal access) and air handling facilities.
动物房必须和其它区域严格分开，并有专门通道(动物进出)和空气处理设施。EQUIPMENT 设备
3.3
4. Manufacturing equipment should be designed, located and maintained to suit its
intended purpose.
生产设备的选型、安装和维护保养必须与预期要求相适应。
3.35. Repair and maintenance operations should not present any hazard to the quality of the products.
维修和保养操作不能对产品的质量产生任何危害。
3.36. Manufacturing equipment should be designed so that it can be easily and thoroughly cleaned. It should be cleaned according to detailed and written procedures and stored only in a clean and dry condition.
生产设备选型必须考虑到能彻底清洁。设备必须根据详细的书面程序清洁并存放在洁净干燥的环境里。
3.37. Washing and cleaning equipment should be chosen and used in order not to be a source of contamination.
设备的洗涤剂和清洁剂不能产生污染。
3.38. Equipment should be installed in such a way as to prevent any risk of error or of contamination.
设备的安装必须避免错误和污染的风险。
3.39. Production equipment should not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard.
生产设备不能对产品有任何危害。生产设备与产品相接触的部分不能与产品发生反应、脱落或吸附产品，以免影响产品的质量和产生危害物。
3.40. Balances and measuring equipment of an appropriate range and precision should be available for
production and control operations.
称量和测量设备的量值和精度必须满足生产和控制要求。
3.41. Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.
测量、称重、记录和控制设备必须通过合适的方法定期进行校准和检测。所有记录必须详细并保留。
3.42. Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.
固定管路必须贴上内容物标识，并标明流向。
3.43. Distilled, deionized and, where appropriate, other water pipes should be sanitised according to written procedures that detail the action limits for microbiological contamination and the measures to be taken.
蒸馏水、去离子水或其它水的管道必须根据书面程序进行消毒，并采取措施对微生物污染进行控制。
3.4
4. Defective equipment should, if possible, be removed from production and quality control areas, or at least be clearly labelled as defective.
对于故障设备必须从生产或质量控制区域移走，或至少要有清楚的故障标识。
CHAPTER 4 DOCUMENTATION 文件
PRINCIPLE 原则
Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.
优良的文件系统是质量保证体系的基本组成部分。清晰的书面文件可以预防口头交接的差错，并提供了生产过程的追溯资料。规范、生产手册和指令、操作程序、以及生产记录必须避免书写错误并便于使用。文件的易读性和易理解性是极其重要的。
GENERAL 一般原理
4.1. Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.
说明书是对产品或所用物料或生产所必须遵循的要求进行的详细描述，它是质量评估的基础。Manufacturing Formulae, Processing and Packaging Instructions state all the starting materials used and lay down all processing and packaging operations.
质量手册、生产和包装指令规定了从起始物料一直到生产和包装的所有过程的活动。
Procedures give directions for performing certain operations e.g. cleaning, clothing, environmental control, sampling, testing, equipment operations.
操作程序给具体的操作例如清洁、服饰、环境控制、取样、检测、设备运行指明了方向。Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent for the quality of the final product.
记录提供了每批产品的生产历史，包括产品的销售，以及其它所有与成品质量相关的信息。
4.2. Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing and marketing authorisation dossiers.
文件应当被认真地计划、起草、审批和分发。文件必须符合当局的生产和市场的相关要求。
4.3. Documents should be approved, signed and dated by appropriate and authorised persons.
文件必须经过负责人批准、进行适当的标识并提供生效日期。
4.4. Documents should have unambiguous contents; title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.
文件内容必须明确；标题、特性和目的必须进行清楚地陈述。文件必须按序分发，并容易核查。文件的复印必须清晰。工作文件在复印过程中不允许任何差错的产生。
4.5. Documents should be regularly reviewed and kept up-to-date. When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents.
文件必须定期进行评估并及时更新。当文件修订时，必须有系统来防止替代文件在使用中的疏忽。
4.6. Documents should not be hand-written; although, where documents require the entry of data, these entries may be made in clear, legible, indelible handwriting. Sufficient space should be provided for such entries.
文件不允许手写；尽管有些文件要求数据的录入是手写，但手写必须清楚、易读、不能被擦掉。手写处必须要留有足够的空白。
4.7. Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.
在文件上出现的任何一处更改都必须要有签名和日期；更改必须要使原数据仍可辨认。必要时要记录更改的原因。
4.8. The records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable. They should be retained for at least one year after the expiry date of the finished product.
所有与药物生产相关的每一个重要活动的过程都必须进行详细的记录，以便追溯。记录至少保存至药品有效期后一年。
4.9. Data may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedures relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data processing methods, only authorised persons should be able to enter or modify data in the computer and there should be a record of changes and deletions; access should be restricted by passwords or other means and the result of entry of critical data should be independently checked. Batch records electronically stored should be protected by back-up transfer on magnetic tape, microfilm, paper or other means. It is particularly important that the data are readily available throughout the period of retention,.
记录数据可以由电子数据处理系统、拍照或其它可靠方法来完成，但是所有使用的系统的相关程序必须是可行的，并且要检查记录的正确性。如果文件是通过电子数据处理系统处理的，那么只有被授权的人员才允许进入计算机系统或修改数据，改动或删除同样要形成记录；进入系统可以通过密码或其它方式来控制，关键数据的入口必须进行单独检查。电子保留的批记录必须要有磁盘、缩微胶片、纸张或其它方式的备份来进行数据保护。数据在整个保存期内易被使用也是非常重要的。
DOCUMENTS REQUIRED 必备文件
Specifications 质量标准
4.10 There should be appropriately authorised and dated specifications for starting and packaging
materials, and finished products; where appropriate, they should be also available for intermediate or bulk products.
起始物料和包装材料的说明书必须经过批准并标明生效日期；必要时，它们对中间体或散装产品同样适用。
Specifications for starting and packaging materials起始物料和包装材料的说明书
4.11. Specifications for starting and primary or printed packaging materials should include, if applicable:
起始物料和内包装材料或已印制好的包装材料的说明书，必须包括：
a) a description of the materials, including: 材料的描述，包括：
.. the designated name and the internal code reference; 特定名称与内部参考编码；
.. the reference, if any, to a pharmacopoeial monograph; 参考药典标准；
.. the approved suppliers and, if possible, the original producer of the products;经批准的供应商，如果有可能，产品的生产商；
.. a specimen of printed materials; 印制好的包装材料的样本
b) directions for sampling and testing or reference to procedures; 取样和检测的说明，或参考程序
c) qualitative and quantitative requirements with acceptance limits; 可接受限值的定性与定量的要求
d) storage conditions and precautions; 贮存条件和防护
e) the maximum period of storage before re-examination. 复验前的最长贮存期
Specifications for intermediate and bulk products 中间产品和待包装品质量标准
4.12. Specifications for intermediate and bulk products should be available if these are purchased or dispatched, or if data obtained from intermediate products are used for the evaluation of the finished product. The specifications should be similar to specifications for starting materials or for finished products, as appropriate.
如果中间体或散装产品被销售、或它们的数据对成品的评估有用，那么它们的规格说明书是必须的。要求与起始物料和成品的说明书的要求相似。
Specifications for finished products 成品质量标准
4.13. Specifications for finished products should include: 成品的规格说明书必须包括
a) the designated name of the product and the code reference where applicable;
产品名称和产品的代码
b) the formula or a reference to; 配方或基准
c) a description of the pharmaceutical form and package details; 药物构成和包装的详细描述
d) directions for sampling and testing or a reference to procedures; 取样和检测的说明或参考的程序
e) the qualitative and quantitative requirements, with the acceptance limits; 可接受限值的定性和定量的要求
f) the storage conditions and any special handling precautions, where applicable; 贮存条件，必要时特殊的防范处理措施
g) the shelf-life. 货架期
MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS 制造手册和生产指令
Formally authorised Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured. They are often combined in one document.
被批准的正式的生产手册和操作指令必须放在每批产品的生产现场。一般情况下它们是文件的一个组成部分。
4.14. The Manufacturing Formula should include: 生产手册必须包括
a) the name of the product, with a product reference code relating to its specification;
产品的名称，与规格说明书要求相一致的产品编码
b) a description of the pharmaceutical form, strength of the product and batch size;
药物构成、产品浓度和批规格的描述
c) a list of all starting materials to be used, with the amount of each, described using the designated name and a reference which is unique to that material; mention should be made of any substance that may disappear in the course of processing;
所使用的起始物料的清单，包括数量、名称必须是唯一的；对于那些由于加工的原因已消失的物料也必须包括
d) a statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable.
预期产量的可接受限值的规定，必要时应当包括相关的中间体的产量
4.1
5. The Processing Instructions should include: 生产指令必须包括
a) a statement of the processing location and the principal equipment to be used; 生产场所和主要设备的综述
b) the methods, or reference to the methods, to be used for preparing the critical equipment (e.g. cleaning, assembling, calibrating, sterilising);
对关键设备的准备工作所使用的方法或参考方法（例如清洁、装配、校准、消毒）
c) detailed stepwise processing instructions (e.g. checks on materials, pretreatments, sequence for adding materials, mixing times, temperatures);
详细的逐步逐条的生产指令（例如物料的检查、预处理、添加物料的顺序、混合时间、温度）
d) the instructions for any in-process controls with their limits; 对在线控制的指令及限值要求
e) where necessary, the requirements for bulk storage of the products; including the container, labelling and special storage conditions where applicable;
必要时，散装产品的贮存要求；包括容器。标签和特殊的贮存条件
f) any special precautions to be observed. 对任何特别要注意的地方必须遵守
PACKAGING INSTRUCTIONS 包装指令
4.16. There should be formally authorised Packaging Instructions for each product for pack size and type. These should normally include, or have a reference to, the following: 每批产品包装规格的包装指令必须经过批准。必须包括或参考以下的内容
a) name of the product; 产品的名称
b) description of its pharmaceutical form, and strength where applicable; 药物构成、浓度的描述
c) the pack size expressed in terms of the number, weight or volume of the product in the final container; 包装规格应当从产品的数量、重量或体积上进行表述
d) a complete list of all the packaging materials required for a standard batch size, including quantities,
大学英语汉译英答案
Unit 4 Translation 1、接受这份工作就得经常在周末上班，但约翰并不在意。 To take this job would involve working on weekends frequently, but John didn’t mind 2、众所周知，肺癌至少部分地是由于吸烟过多而引起的。 It is well know that lung cancer is caused at least in part by smoking too much. 3、我祖父母说，发明电视的那个人曾住在他们那个地段。 My grandparents said that the man who invented television had once lived in their neighborhood. 4、我提议咱们会后马上去办公室找史斯密教授，邀请他参加我们的英语晚会。 I propose that we go to find Prof. Smith in his office right after the meeting and invite him to our English evening 5、她因那病开过两次刀，身体十分虚弱，几乎站不起来。 Having been operated on twice for the disease, she was so weakened that she could barely stand up 6、教育家们认为，伴随着电视机长大的一代人，在电视机前花的时间太多，以致没有足够的时间学习了。Educators think that the generation growing up with television spend so much of their time in front of the TV that they do not have enough time to study. 7、我真希望你能拿出一个比这更好的解决办法来。 I do hope that you can come up with a better solution than this. 8、乍一看，这幅画并不好，但经过仔细观察，我们才发现它的的确观察，我们才发现它的确是一幅杰作。 At first glance the picture didn’t l ook very good, but after examining it carefully we found that it was indeed a masterpiece. Unit 5 Translation 1、史密斯医生从窗口望出去，突然看到一个年轻人正向他的诊所奔来。 Looking out of the window, Dr. Smith caught sight of a young man running towards his clinic. 2、艾米过去除了咖啡什么都不喝。 Amy used to drink nothing but coffee. 3、迈拉得知丈夫在事故中受了伤便哭了起来。 Myra broke into tears when she learned that her husband had got injured in an accident. 4、我们好几天没有看见怀特小姐了。她是病倒了还还是怎么了？ W haven’t seen Miss White for quite a few days. Has she fallen ill of somethi ng? 5、研究所所长亲自查明一切都没有问题。 The director of the research institute came in person to make sure that everything was all right. 6、伦尼今天早晨上学又迟到了。他应该早一点起床的。肯定是昨晚睡得太迟了。 Lennie was late for school again this morning. He ought to /should have got up earlier. He must have stayed up too late last night 7、嗨，你不应该把那些孩子赶跑。他们是来帮忙的，不是来捣蛋的。 Say you oughtn’t to have driven away those kids. They came to lend you a hand, not to make trouble. 8、对护士来说，坚持这项规定是很重要的。 It is important for nurses to stick to this rule. Unit 6 Translation 1、据报道，那条铁路曾因洪水而停止修建。 It was reported that the building of the railway had been held up by a flood. 2、罢工结果，资方接受了工人的要求。 The strike resulted in the management accepting the workers’ demands. 3、煤矿工人们决定为争取更好的工作条件举行罢工。 The coalminers decided to go on strike for better working conditions 4、我很想买下这本英文词典，遗憾的是我身上带的钱不够。
英语汉译英翻译
Unit 1 1.餐饮行业与电影行业的共同之处在于其小型企业的失败率很高。 The restaurant industry has one thing in common with the film industry: the high failure rate among its small business. 2.他的伟大在于他具有非凡的能力，集科学家和实业家的品质于一身。 His greatness lies in his outstanding ability to connect the qualities of a scientist with those of an industrialist. 3.像工作单位取代居住地一样，我们的种族身份已被职业身份所取代。这一现象在流动作业的行业中表现得尤为明显。 We have replaced ethnic identity with professional identity, the way we replaced neighborhoods with workplace, which is quite obvious among the mobile professions. 4.显然，任何一家大公司的老板都不可能事事亲力亲为，需要找一些方法把他们的理念传达给他人。 Plainly, in any large enterprise the boss cannot be directly involved in everything, and some means have to be found to transfer his belief to others. 5.没有任何人愿意再过那种自己无法控制、要别人认可、任人摆布的日子了。No one was willing to experience the feeling of being out of control and dependent on someone else’s approval, at someone else’s mercy. 6.人们渴望一种成就感，渴望有能力凭自己的手、自己的脑、自己的意志办成事情。 The human being longs for a sense of accomplishment, and being able to do things, with his hand, with his mind and with his will. 7.政府希望通过大量出售资产来弥补损失。 The government hopes that the sale of a chunk of its assets will help make up for its lose. 8.现代社会里人们的身份更多地由他们所从事的职业，而不是他们所生活的社区来界定。
英国政体总介绍(中英文)
英国指南.英国的内政.英国的政体 （1）君主政制 女王拥有什么权力？ 王国政府代表英王（即宪法赋予其统治王国权力的人）及政府，也是最高行政机构的象征。英女王拥有王国政府的统治权，但行使有关权力的，一般都是向国会负责的部长级官员，因此英国实际上是由英国政府代替女王管治的。然而，大部分重要的政府议案仍须得到女王同意方可获得通过。 国会 女王有权召开、解散或下令国会休会。新一年度国会在召开第一次会议前，女王均会发表一篇由政府官员撰写的演辞，内容主要简述政府新一年的工作大纲。每项议案均须得到女王在国会两院宣布正式批准方能成为法律。 女王在部长的建议下有权特赦囚犯或宣布减刑。根据法律规定，女王个人是不会犯法的——因为她获民事及刑事起诉的豁免权，法庭也不能起诉她。然而，其他王室成员却不能享有该项豁免权。 勋衔及委任女王有权册封贵族、颁授爵位及其他勋衔。受勋人士名单通常由首相提名，但某些勋衔则由女王自己决定。许多重要的国家职位均由女王委任，人选则由首相或有关内阁大臣提名。 外交政策 各国派驻伦敦的外交人员均须得到女王的同意，她有权缔结条约、发动战争或议和、确认海外国家及政府、吞并及割让领土。 枢密院 女王负责主持枢密院的会议。按君主特权所订立的枢密令，以及其他法令均是由枢密院通过的。君主特权包括组织行政机关，而政府的权力则受制于宪法习惯（这些规则本身并非法律，但对政府的运作却异常重要）。 所有涉及君主特权的行为，均须由有关部长负责执行，他们须向国会负责，并就各项政策接受国会议员的质询。国会有权撤消或限制有关特权的行使。 除了听取各项报告外，女王也可随时就国民生活情况向其官员发表意见。 为什么英女王有两个生日呢？ 女王的出生日期是在4月21日。但传统以来，英国人都习惯于夏天庆祝君王的寿辰。由1805年起，英国人开始以举行军旗礼来庆祝君王的官方寿辰，日期通常是定于6月的第二个周末。 这个仪式的本来目的是让士兵熟识其所属兵团的旗帜式样，以便日后行军打仗时易于识别。五个步兵团，包括近卫步兵第一团、Coldsteam步兵团、苏格兰、爱尔兰及威尔士步兵团，每年按编制负责于仪式上展示其军旗。 仪式开始时，女王会在王室骑兵军官的陪同下骑马离开白金汉宫，沿着林荫大道步往骑兵卫队的阅兵场，检阅五百名卫兵。军旗礼展示的军旗依照卫兵的官阶高低排列，每队卫兵随着军旗带领，在步兵团的陪同下，分列式步操经过女王面前。至于女王正式生日当天，并无特别仪式举行，只是各政府大楼会有升国旗及播放国歌，以示庆祝。 王位继承人的排列次序如下： 1.威尔斯王储（1948年生）
新视野大学英语读写教程汉译英翻译答案
第一单元 1. The plant does not grow well in soils other than the one in which it has been developed. 2. Research findings show that we spend about two hours dreaming every night, no matter what we may have done during the day. 3 .Some people tend to justify their failure by blaming others for not trying their best. 4. We remain tree to our commitment: Whatever we promised to do; we would do it. 5. Even Beethoven's father discounted the possibility that his son would one day become the greatest musician in the world. The same is true of Edison, who seemed to his teacher to be quite dull. 6. They were accused by authorities of threatening the state security. 第二单元 1 ．If the characters in this comedy had been more humorous，it would have attracted a larger audience．‘ 2. She has never lost faith in her own ability, so it is a possibility for her to become a successful actress. 3 ．I never had formal training，I just learned as I went along? 4. As their products find their way into the international
英语(汉译英)
公交常用英语 一、常用词语： 1、公共汽车 Bus 巴斯 2、出租车 Taxi 太克sei 3、电车 Trolleybus 超类巴斯 4、您好 Hello / How do you do. 好度有度 5、劳驾或请问 Excuse me…… A科斯Q私密 6、抱歉或对不起 Sorry 扫瑞 7、对不起打扰了 I’m sorry to trouble you 阿姆扫瑞兔揣宝有 8、谢谢 Thank you / Thanks 9、没关系 Not at all / It doesn’t matter 闹特爱特奥/ A特大怎特迈特 10、可以 It’s OK. A次欧凯 11、月票 commutation / monthly ticket 抗缪忒什/ 忙特雷忒K特 12、票价 carfare 卡fai尔 13、起点站 The starting stop 泽思达挺思道普 14、终点站 terminal / The Last stop 特妹闹泽拉斯特思道普 15、市区路线 Urban route 饿本入特 16、郊区路线 Suburban route 瑟波本入特 17、请等一下 Wait a moment 维特饿某们特 18、再见 Goodbye / Bye 19、首班车 The first bus 泽发斯特巴斯 20、末班车 The last bus 泽拉斯特巴斯 21、驾驶员 Driver 拽玩儿 22、乘务员 Conductor 肯达科特儿 23、调度员 Dispatcher 得死派车儿 24、请上车 Get on please 盖特昂普类似 25、请下车 Get off please 盖特奥夫普雷斯 26、中国济南 Jinan , China 济南柴那 27、空调车 Air-conditioned bus 艾尔可得什恩德巴斯 28、K系列豪华车 K series bus /可sei儿瑞丝巴斯 K series comfortable express 可sei儿瑞斯抗木否特包A科丝普ruai 丝 29、欢迎您！ Welcome 维尔康目 30、先生，您好！ How do you do , sir? 好读有度色儿31、小姐，你好！ How do you do , miss?
The United Kingdom 英国介绍_中英文
The United Kingdom, including Great Britain (England, Wales and Scotland "and Northern Ireland, is a member of the European Community 12. Its full name is the United Kingdom. Britain is the British Isles by the majority of islands, of which the largest islands are Great Britain, the second largest island Northern Ireland and the Irish Republic. The west coast of Scotland there is a large islands called the Hebrides. Native north-east coast of Scotland Orkney Islands, Shetland Islands, and Samoa. Of these islands with the mainland have administrative relations, but the Irish Sea between Great Britain and the Isle of Man and the Channel Islands between France is largely autonomous and not an integral part of the United Kingdom. The United Kingdom area of approximately 242.5 thousand square kilometers (93600 square miles), from the south coast to Scotland is almost the most northern part of nearly 1,000 kilometers (about 600 miles), nearly horizontal at its widest point about 500 kilometers (about 300 miles). "Britain" the term originated in the Greek and Latin words, which may eventually be traced back to Celtic. Although the use of "Prehistoric" This yardstick to measure, the Celtics went to the British Isles is also a later (and before that had created those civilizations such as the Avebury stone circle Stonehenge construction sites and Such well-known historical monuments), but the history of written records relating to England, after all, about the Celtics from the start. "Celtic" This phrase is very common and regularly used to distinguish the early inhabitants of the British Isles and later the Anglo - Saxon invaders. The Romans ruled from AD 43 onwards lasted 300 years. The Romans in 408 before the final withdrawal of the island were from Northern Europe began to Angles, Saxons and Jutes intrusion, has undergone a period of growing chaos. "England" is the word from the "Angles" came. Over the next two centuries, and gradually became a settler harassment and the establishment of a number of small kingdom. British people in today's Wales and Cornwall Regional Independent survive. These small kingdom there was relatively strong to dominate the country's kingdom, first in the North (Northumbria Kingdom), and then in the central (the Kingdom of Mercia), and finally in the south (Wessex kingdoms). However, from the Scandinavian Vikings then invaded England and settled down, although in the 10th century Wessex dynasty, beat off the invading Danes and for a time to dominate the vast region of England. In 1066 took place on the last successful invasion of England. Duke William of Normandy in the Battle of Hastings defeated the British, the Normans from France and others come here to settle. In the ensuing three centuries, the French became the language of nobility, the legal structure has been the English Channel on the other side of the passage of that set of consequences, and social structure, to some extent been affected. Wales, though often in England within the sphere of influence, but has been a bastion of Boston. However, in the Prince Llewellyn was killed in 1282, after Edward I waged a battle and victory to put England under the rule of Wales. Welsh nationalist sentiment continues to rise, the beginning of the 15th century rebellion led by Owen
DCS常用单词中英文对照讲解
英文全称英文缩写中文 ( front ) big platen BIG PLTN 大屏 1st extraction 1ST EXTR 一段抽汽abnormal ABNM 异常accident ACDT 事故acknowledge ACK 确认 act ACT 动作 active ACTIVE 激励 active power A_PW 有功功率adjusting ADJ 调整admission ADMS 进汽 Air AIR 空气 Air flow AIR FLOW 风量 air leakage AL 漏风 air preheater APH 空预器 air side AIR_S 空侧 alarm ALM 报警 alarm window ALM WIN 光字牌 all phases 3 PH 全相alternating current AC 交流 area AREA 分区 area AREA 区 ash hopper ASH HOP 灰斗atmospheric relief valve ATM REL VLV 对空排汽门atomizing ATOM 雾化attemperating DT 减温attemperator，desuperheater DTR 减温器automatic AUTO 自动Auxiliary AUX 辅助 axial displacement AXI DISP 轴向位移Back BA 后 be out of order N_ORDER 失灵bearing BEAR 轴承Bearing box BEAR BOX 轴承箱Bearing vibration BEAR VIB 轴振begin BEGIN 开始behind BH 在…的后面belt BELT 皮带 bin BIN 煤粉仓bin, pulverized coal bunker BIN 粉仓
大学英语5_汉译英
掌握大量的词汇对于达到一门外语的流利程度是至关重要的。一个非官方的但却是经常被引用的有关剑桥初级证书英语考试（Cambridge First Certificate Examination）的数字表明，词汇量少于三千五百词的学生不大有可能在这项考试中成功。最近的研究也表明，其母语为英语的受教育至18岁或18岁以上的人至少认识一万六千个英语词。除非你已经会讲一种像西班牙语或德语这样的语言，要获得大的英语词汇是没有捷径可走的：你就得依靠勤奋和专注。当然，你可以从上下文猜出你阅读中遇到的一些生词的意思，但往往你得查词典才能搞清它们确切意思。一个切实可行的学习新词的方法或许就是大量阅读，最好是读那些你觉得有趣或刺激的故事。反复阅读同一本书常常是很有好处的：你每读一次都会学到不同的生词，而熟悉的背景又有助于将这些新词牢牢地印在你的脑海中。 Mastering a large number of words is essential to achieving fluency in a foreign language. An unofficial, but often quoted, figure for the Cambridge First Certificate examination suggests that students with a vocabulary of less than 3,500 words are unlikely to be successful in the exam. Current research also suggests that native English speakers who have been educated up to 18 years old or beyond know at least 16,000 English words. And unless you already speak a language like Spanish or German, there are no shortcuts to a large vocabulary in English: you just have to rely on diligence and dedication. Of course you can figure out from the context the meanings of some new words you come across in your reading, but more often than not you have to look them up in a dictionary in order to be clear about their accurate meanings. A practicable way to pick up new words is, perhaps, to read a lot, preferably stories that you find interesting or exciting. It often pays to read the same book over and over again: each time you read it you will learn different new words, and the familiar context helps to fix them in your mind.
汉译英翻译方法
汉译英三步骤： 1.理解原文 包括原文逐字逐句的理解、对原文整体思想、观点和态度的理解，也包括对原文句子之 间和各部分之间相互关系的理解。 2.英语表达 在正确理解原文的基础上进行的，不是一对一的死译，而是在理解原文的基础上用相应 的英语结构、词汇和表达习惯准确的表达原文的意思。 3.核对检查 认真阅读自己的译文，要用挑错的眼光来检查译文是否正确表达了原文的意思，是否有 漏译、错译，译文语法如时态、语态、单复数形式和拼写上是否有错误。 汉译英翻译技巧： 1.选择恰当的英语词汇 有些英语词汇不仅有字面意思，还有内含意思。 e.g.“国家”：country, nation, state, land 分别内涵：疆土、人民、政府、感情 有些英语词汇本身含有贬义或一些委婉的意思，运用时要特别注意。 e.g.“宣传”publicize, propaganda （带贬义） 汉译英选词原则： （1）选适合上下文的词汇 e.g.“观众”：audience,viewer, spectator 分别表示：听音乐会或看戏的观众、电视观众、看体育表演的观众 “条件”不同情况下应用不同的英语词表达： 工作条件：working condition 有利的条件：favorable situation 录取条件：admission requirement 付款条件：terms of payment 词汇选择首先要忠于原文的意思。 e.g.近年来由于就业问题日益严重，有些人建议让没有工作的未婚妇女来替换那些 家务繁重的女工。 “就业问题”：employment problem, unemployment problem（找不到工作就业已 成问题，即失业问题） “没有工作的妇女”: women without jobs, women hunting for jobs（没有工作又 需要找工作的妇女，不需找工作的并不包括在内） （2）要注意词的广义、狭义、具体的意思和抽象意思的不同 e.g. ①他讲的笑话逗得我们都笑了。 ②他讲的话使我们大家都笑了。 ①His joke made us laugh. ②What he said make us laugh. We all smile at what he said. （3）选词时不要望文生义，不要死译，要考虑与汉语对应的英语词汇真正的意思。 e.g.①他们的好奇心得到了满足。
新视野大学英语3课后汉译英答案(全)
第1单元：（此单元无汉语） 1. No matter how experienced a speaker you are, and how well you have prepared your speech, you will have difficulty making a speech at such a noisy reception. 2. Just as all his sister’s friends cared about him, Jimmy cared about them. 3. Car manufacturers stamp a vehicle identification number at several places on new cars to help track down stolen vehicles. 4. If you dare tell on me when the teacher gets back I won’t say a word to you any more. 5. Some elderly people prefer to live on their own while the great majority choose to live with their children. 6. Here is something that needs to be reckoned with: how to get the necessary finances to establish the company. 第2单元： 1、被告是位年仅30岁的女子，她坚称自己无罪。 The defendant, a woman of only 30, kept insisting on her own innocence. 2、总体看来，枣、豆类以及一些多叶的绿色蔬菜是最好的铁质来源。 All tings considered, dates, beans and some leafy green vegetables are the best sources of iron. 3、正餐时不供应饮料，饮料会影响消化。 No beverages are served with meals because they interfere with digestion. 4、考虑到那个地区受欢迎的程度，提前订宾馆是明智的。 Taking the popularity of the region into consideration, it is advisable to book hotels in advance. 5、服药后若有呕吐感，请立即停止服用并尽快咨询医生。 If you have a feeling of wanting to throw up after taking this drug, stop taking it immediately and consult your doctors as soon as possible. 6、总结这次讨论时，他说双方都会好好考虑怎样以最有效的方法来解决这一问题。 Summing up the discussion, he said both parties should consider the most effective way to solve the problem. 第3单元 1、在思维方面，与他的行为一样，他是非常传统的。 In his thinking, as in his behavior, he is very traditional. 2、教室一旦同意接受新的教学计划，他们就得面对新计划所带给他们的压力。 Once the teachers agree to accept the new teaching program, they have to face the strain it puts on them. 3、从长远看，大学毕业后继续深造而不是直接参加工作是值得的。 In the long run, it is worthwhile to pursue one’s study after graduating from universi ty instead of going to work directly. 4、由于这所学校的办学宗旨是品德第一，所以道德观和学习成绩受到同样的重视。 As the school operates on the Character First principle, moral values and academic achievements are stressed equally. 5、据说，原定于这个月召开的会议将推迟到下个月召开。 It is said that the meeting, which is scheduled to be held this month, will be put off till next month.
建筑专业词汇中英对照(精心整理版)
1DESIGN BASIS 设计依据 计划建议书planning proposals 设计任务书design order 标准规范standards and codes 条件图information drawing 设计基础资料basic data for design 工艺流程图process flowchart 工程地质资料engineering geological data 原始资料original data 设计进度schedule of design 2STAGE OF DESIGN 设计阶段 方案scheme, draft 草图sketch 会谈纪要summary of discussion 谈判negotiation 可行性研究feasibility study 初步设计preliminary design 基础设计basic design 详细设计detail design 询价图enquiry drawing 施工图working drawing, construction drawing 竣工图as built drawing 3CLIMATE CONDITION 气象条件 日照sunshine 风玫瑰wind rose 主导风向prevailing wind direction 最大(平均)风速maximum (mean) wind velocity 风荷载wind load 最大(平均)降雨量maximum (mean) rainfall 雷击及闪电thunder and lightning 飓风hurricane 台风typhoon 旋风cyclone 降雨强度rainfall intensity 年降雨量annual rainfall 湿球温度wet bulb temperature 干球温度dry bulb temperature 冰冻期frost period
大学英语3汉译英
Unit1 Caring for Our Earth 1.年轻人有时会抱怨无法和父母沟通。(communicate with) Young people sometimes complain of being unable to communicate with their parents 2. 能在中国云南的一个苗家村落住下来一直是玛丽长久以来的梦想，现在她终 于梦想成真了。(to take up residence) It has been Mary’s long cherished dream to take up residence in a Miao vill age in Yunnan, China. Now her dream has finally come true. 3.家养的动物习惯于依赖人，因此很难能在野外活下来。(survive) Domestic animals are used to depending on humans, so it is difficult for the m to survive in the wild. 4.他突然有种恐惧感，觉得自己会因为经济不景气而被公司裁员。(overtake) He was suddenly overtaken by a fear that he would be laid off by the comp any because of depression. 5.我估计公交路线上堵车了，因为我都等了30分钟也没见一辆车开过去(figure) I figure that there is a traffic jam on the route of the bus, for I’ve waited for 30 minutes without seeing one passing by. 1. 十年前，当公司还处在生产的鼎盛时期时，我们就决定投资新技术， 将公司转型为技术密集型企业。由于拥有先进技术，我们在激烈动荡的市场竞争中脱颖而出。现在我们的成本下降了百分之三十，销售业绩却上涨了三分之二，利润翻了一番。 Ten years ago, when our company was at the height of i ts production, we decided to invest in new technologies, so as to tur n our company into a technology-intensive one. With our advanced tech nologies, we out-competed all our competitors in the rough and tumble of the marketplace. Now we have reduced the cost by 30 percent, even as / while our sales have grown by two-thirds and the earnings have doubled. 2. 我们将可持续性定义为保持企业盈利，但不以环境为代价。从商业的角度看，这合理吗？事实上，在追求可持续发展目标的过程中，我们的收益已经超过了所有的投资和开支。可持续发展的推进起到了如此重要的作用，帮助我们撑过了史上最深重的经济衰 We define sustainability as keeping a business profitable, but not at the expense of the environment. Does this mak e good business sense? Actually, what we get has more than offset all
汉译英部分(全)
汉译英部分 第一课 等截面Constant cross section，单位面积上的力Unit area on the force杆件的横截面面积A cross-sectional area of the member横截面的形心Centroid of the cross section单位长伸长量Elongation per unit length相邻横截面Adjacent cross-section除非另有说明Unless otherwise noted 力的集度。即是单位面积上的力，称为应力The force set degrees, that is the force per unit area, known as stress 应力常用希腊字母@来表示Stress commonly used Greek letters @ 单位长度的伸长量称为应变，常来以下公式确定Unit length of elongation is called strain, often to the following formula to determine 材料力学是应用力学的一个分支The materials mechanics is a branch of applied mechanics 材料力学讨论固体在承受各种荷载时的性能Of Material Mechanics Discussion solid performance under various loads 第二课 临界应力Critical stress欧拉公式Euler's formula比例极限Proportional limit强度极限Strength limit非弹性屈曲Inelastic buckling平均压应力Average compressive stress回转半径Radius of gyration许可应力Allowable stress 我们注意到临界应力的变化和柱子长细比的平方成反比We note that the critical stress changes and pillars slenderness ratio is inversely proportional to the square of 如果，柱子将由于弹性屈曲而失效，欧拉公式可以应用If, pillars elastic buckling failure.Euler's formula， 曲线ABC是根据公式2-1绘制的，被称为欧拉曲线Curve ABC is according to the formula 2-1 draw, is called the euler's curve 结构工程安全系数的典型值介于1.5和3这一范围内。The structural engineering typical value of the safety factor of between 1.5 and 3 within this range 第三课 温度差Temperature difference 补救措施Remedial measures 补安全度规范Complement safety norms， 雨水积聚Rainwater accumulation 概率密度函数Probability density function 概率曲线Probability curve 失效概率Probability of failure 分项安全系数Partial safety factors 结构必须具备抗破坏的安全度和实用时的实用性The structure must have anti undermine the security and practical usefulness 作用在结构上的荷载可分为三大类。Effect on the structure of the load can be divided into three categories. 像活荷载一样，某时刻的环境荷载无论大小还是分布都是不确定的 Like live load, a time of environmental load regardless of size or distribution is uncertain