美国药品生产质量管理规范
210部分和211部分
PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF
DRUGS; GENERAL
210部分人用及兽用药品的生产、加工、包装或贮存的CGMP
编者说明：英文版2010-05-23取自FDA官方网站
中文版取自中国GMP网友关大鹏2009-12-18的发的2003-12译本
两个版本可能稍有不同，不同之处红字标示。
目录
210.1 cGMP法规的地位 (2)
210.2 cGMP法规的适用性 (2)
210.3 定义 (2)
211-A- 总则 (4)
211-B- 组织与人员 (4)
211-C- 厂房和设施 (5)
211-D- 设备 (7)
211-E- 成份、药品容器和密封件的控制 (8)
211-F- 生产和加工控制 (10)
211-G- 包装和标签控制 (11)
211-H- 贮存和销售 (13)
211-I- 实验室控制 (14)
211-J- 记录和报告 (16)
211-K- 退回的药品和回收处理 (20)
Sec. 210.1 Status of current good manufacturing practice regulations.
210.1 cGMP法规的地位
(a) The regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.
(a) 在本部分及21CFR 211—226部分中陈述的法规是在药品生产、加工、包装或贮存中使用的现行生产质量管理规范及使用的设施或控制的最低标准，以保证该药品符合联邦食品、药品及化妆品法对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征。
(b) The failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.
(b) 凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211—226部分中陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该药应被视为劣药，同时
导致该事故发生的负责人应受相应的法规的制裁。
(c) Owners and operators of establishments engaged in the recovery, donor screening, testing (including donor testing), processing, storage, labeling, packaging, or distribution of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271.3(d) of this chapter, that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act), are subject to the donor-eligibility and applicable current good tissue practice procedures set forth in part 1271 subparts C and D of this chapter, in addition to the regulations in this part and in parts 211 through 226 of this chapter. Failure to comply with any applicable regulation set forth in this part, in parts 211 through 226 of this chapter, in part 1271 subpart C of this chapter, or in part 1271 subpart D of this chapter with respect to the manufacture, processing, packing or holding of a drug, renders an HCT/P adulterated under section 501(a)(2)(B) of the act. Such HCT/P, as well as the person who is responsible for the failure to comply, is subject to regulatory action.
[43 FR 45076, Sept, 29, 1978, as amended at 69 FR 29828, May 25, 2004]
Sec. 210.2 Applicability of current good manufacturing practice regulations.
210.2 cGMP法规的适用性
(a) The regulations in this part and in parts 211 through 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use; and in part 1271 of this chapter as they are applicable to a human cell, tissue, or cellular or tissue-based product (HCT/P) that is a drug (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act); shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.
(a) 本部分及21CFR 211—226适用于普通药品，21CFR 600—680适用于人用生物制品，除非另有明确规定，否则上述两者之间应该是相互补充而不是相互取代。如有上述两部分的法规不适用的药品，则可用特定的具体法规来替代。
(b) If a person engages in only some operations subject to the regulations in this part, in parts 211 through 226 of this chapter, in parts 600 through680 of this chapter, and in part 1271 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which he or she is engaged.
(c) An investigational drug for use in a phase 1 study, as described in 312.21(a) of this chapter, is subject to the statutory requirements set forth in 21 U.S.C.
351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter. However, this exemption does not apply to an investigational drug for use in a phase 1 study once the investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3 study, as described in 312.21(b) and (c) of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed, the drug for use in the phase 1 study must comply with part 211.
Sec. 210.3 Definitions.
210.3 定义
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 through 226 of this chapter.
(a) 在联邦食品、药品及化妆品法201部分中包含的定义和解释、说明适用于21CFR 211—226部分中的术语。
(b) The following definitions of terms apply to this part and to parts 211 through 226 of this chapter.
(b) 下面定义的术语适用于本部分及21CFR 211—226。
(1)Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301et seq. ). (1) 法(Act) 指联邦食品、药品及化妆品法，修订版(21 U.S.C 301 et seq.)。
(2)Batch means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
(2) 批(Batch) 指在规定限度内，按照某一生产指令在同一生产周期内生产出来的，具有同一性质和质量的一定数量的药品或其它物料。
(3)Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.
(3) 组分(Component) 指用于药品生产的所有成份，包括那些未在药品中出现的成份。
(4)Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in
association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.
(4) 药品(Drug Product) 指成品制剂(如：片剂、胶囊剂、口服液等)，通常含有一种活性成份并伴有非活性成份(但不是必需的)。本术语也包括不含有活性成份但作为安慰剂使用的成品制剂。
(5)Fiber means any particulate contaminant with a length at least three times greater than its width.
(5) 纤维(Fiber) 指长度大于其宽度的3倍的任何微粒状污染物。
(6)Nonfiber releasing filter means any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered.
(6) 无纤维脱落的过滤器(Non-fiber-releasing filter) 指任何经过适当的预处理(如清洗或冲洗)后，不会将纤维脱落到已过滤的组分或药品中的所有过滤器。所有含石棉过滤器均被认为是有纤维脱落的过滤器。
(7)Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.
(7) 活性成份(Active Ingredient) 是指所有用于保证药物活性或其他在疾病的诊断、治愈、缓解、治疗或预防中起直接作用，或影响人或其他动物身体结构或功能的组分。本术语包括那些能承受药品生产中的化学变化和为了保证其指定的活性或作用以一种经调整的形式存在于药品中的组分。
(8)Inactive ingredient means any component other than an active ingredient.
(8) 非活性成份(Inactive ingredient) 指不同于“活性成份”的其他组分。
9)In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.
(9) 中间产品(In-process material) 是指所有经制备、复合、混合或由化学反应得到的用于药品生产或制备的物料。
(10)Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced
by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.
(10) 批（lot）指一批或是一批中特定的均一部分，在指定的范围内具有相同的性质和质量；或者若为由连续的生产过程制造出的药品，“批”指在单位时间或单位数量生产出的特定的、均一的部分，并且确保该部分在指定的范围内具有均一性质与质量。
(11)Lot number, control number, or batch number means any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.
(11) 批号(Lot number, control number，batch number) 指由字母、数字、符号或他们的组合组成，由此可确定某批药品或物料的生产、加工、包装、贮存或销售的情况。
(12)Manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products.
(12) 药品的生产、加工、包装或贮存(Manufacture, processing, packing, or holding of a drug product) 包括药品的包装和标签操作、检验、质量控制。
(13) The term medicated feed means any Type B or Type C medicated feed as defined in 558.3 of this chapter. The feed contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated feeds is subject to the requirements of part 225 of this chapter.
(13) 药用物料(medicated feed) 指在21CFR 558.3中定义的B型和C型药用物料。该物料含有联邦食品、药品及化妆品法201(g)部分中定义的一种或一种以上的药物，药用物料的生产应符合21CFR 226部分中的要求。
(14) The term medicated premix means a Type A medicated article as defined in 558.3 of this chapter. The article contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated premixes is subject to the requirements of part 226 of this chapter.
(14) 药用预混合料(medicated premix) 指21CFR 558.3中定义的A型药用物质。该预混合料含有联邦食品、药品及化妆品法201(g)部分中定义的一种或一种以上的药物。药用预混合料生产应符合21CFR 226部分中的要求。
(15)Quality control unit means any person or organizational element designated by the firm to be responsible for the duties relating to quality control.
(15) 质量控制部门(Quality control unit) 指由企业任命负责质量控制相关责任的任何人员或组织机构。
(16)Strength means:
(16) 含量或效价（Strength）指：
(i) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or
(Ⅰ) 原料药的浓度(如：以重量/重量、重量/体积、单位剂量/体积为基础)；和/(或)
(ii) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).
(Ⅱ) 活性(效价)也即由适当的实验室检测或由足够的临床数据得出的指定的药品治疗活性(如：可表达为对照于某标准的单位的术语)。
(17)Theoretical yield means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.
(17) 理论产量(Theoretical yield) 指在生产、加工或包装某种药品的任一适当阶段中，并且基于所使用的组分的数量在实际生产中无任何损失或错误的情况下，应能生产的数量。
(18)Actual yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.
(18) 实际产量(Actual yield) 指某种药品在生产、加工、包装的任一适当的阶段实际生产出的数量。
(19)Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.
(19) 比率(Percentage of theoretical yield) 实际产量(生产、加工或包装某种药品的适当阶段)与理论产量(在相同阶段)的比率，以百分数表示。
(20)Acceptance criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).
(20) 验收标准(Acceptance criteria) 建立在相应的取样方法基础上的药品的质量检验标准和合格、不合格标准(如合格质量水平和不合格的质量水平)，是决定批准或拒收一批(或其他生产单元的小组)药品的必需因素。
(21)Representative sample means a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled.
(21) 代表性样品(Representative sample) 指一个样品按合理的标准抽取（如随机取样法），并包含若干单位（元），以能保证样品准确描绘被取样品的物料。
(22) Gang-printed labeling means labeling derived from a sheet of material on which more than one item of labeling is printed.
PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 211部分
Subpart A--General Provisions
A．总则
Sec. 211.1 Scope.
211?1范围
(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.
（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产质量管理规范（GMP）
(b) The current good manufacturing practice regulations in this chapter as they pertain to drug products; in parts 600 through 680 of this chapter, as they pertain to drugs that are also biological products for human use; and in part 1271 of this chapter, as they are applicable to drugs that are also human cells, tissues, and cellular and tissue-based products (HCT/Ps) and that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act); supplement and do not supersede the regulations in this part unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.
（b）在本章里的这些针对药品的现行GMP条例和本章600至800的所有部分针对人用生物制品的现行GMP条例，除非明确另有说明者外，应认为是对本部分条例的补充，而是不代替。本章其他部分或本章600至680各部分和本部分均可适用的条例，前部分的条例可代替本部分条例。
(c) Pending consideration of a proposed exemption, published in theFederal Registerof September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice. （c）在考虑经提议的，发表在1978年9月29日联邦注册表（FR）上一项免除时，若产品及其所有成份是以人用物品形式作一般销售和消费且这些产品根据其预期用途，亦可列入药品的范围内，则不应对这些非处方药（OTC）实施本部分条例，直至进一步的通知为止。本章110部分和113至119部分的条例用于鉴别这些变是食品的OTC药品是否按照GMP的要求生产、加工、包装和贮存。
Sec. 211.3 Definitions
The definitions set forth in 210.3 of this chapter apply in this part.
211?3定义
本章210?3中的定义适用于本部分。
Subpart B--Organization and Personnel
B．组织与人员
Sec. 211.22 Responsibilities of quality control unit.
211?22质量控制部门的职责
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.
（a）本部门有批准和拒收所有成份、药品包装容器、密封件、中间体、包装材料、标签及药品的职责与权力。复查生产记录和权力，保证不产生差错，或若发生差错，保证他们充分调查这差错。本部门负责根据合同，批准或拒收由其它公司生产、加工、包装或贮存的药品。
(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.
（b）适当的实验室检验设备、批准（或拒收）各种成份、药品容器、密封件、包装材料及药品，质量控制部门是可以获得的。
(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.
（c）本部门有批准或驳回影响药品的均一性、效价或含量、质量及纯度的所有程序或规格标准的职责。
(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.
（d）适用于本部门的职责与程序，应成文字材料，并应遵循。
Sec. 211.25 Personnel qualifications.
211?25人员资格
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
（a）每位从事药品生产、加工、包装或仓贮工作人员，应接受培训、教育及有实践经验，完成委派的各项职务。培训是按照现行GMP（包括本章中的现行GMP条例和这些条例要求的成文程序）中涉及雇员的内容。邀请合格人员指导，并连续多次培训，保证雇员熟悉现行GMP对他们的要求。
(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
（b）负责监督药品的生产、加工、包装或仓贮工作的每一个工作人员，应受教育、培训及有经验，完成委派的各项职务。以此作为提供药品具有安全性、均一性、效价或含量、质量及纯度的保证。
(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
（c）有足够量招待和监督每种药品的生产、加工、包装或仓贮的合格人员。
Sec. 211.28 Personnel responsibilities.
中英文对照版 自检互检，确保产品零缺点！ Self and mutual inspection, make sure zero defection! 杜绝不良思想，发扬优质精神！ Prevent unhealthy thinking; develop high quality inspirit. 持续的质量改进，是我们永恒的目标。 Quality continuous improvement is our eternal objective. 积累点滴改进，迈向完美品质。 Accumulate every improvement is led to Perfect quality 培养优质素养，提高团队力量。 Quality-cultivation,Strengthens our team 不为失败找理由，要为成功找方法。
Do not make excuses for failure, but find a way to solve it. 客户满意，是检验我们工作的唯一标准。 Customer satisfaction is the only benchmark to inspect our works. 没有执行力，就没有竞争力。 No implementation power; no competitiveness advantage. 执行力文化，是从负责任开始的。 Implementation starts from taking responsibility 消除一切浪费，追求精益求精和不断改善。 Stop waste to pursue perfection and constant improvement 。 节约是美德，珍惜能源点滴。 Saving is our virtue, treasure every bit of resource 。 努力是将工作做完，用心是将工作做好。
论语 CONFUCIAN ANALECTS
学而第一 『⒈１』子曰：“学而时习之，不亦说乎？有朋自远方来，不亦乐乎？人不知而不愠，不亦君子乎？” The Master said: "Is it not pleasant to learn with a constant perseverance and application? "Is it not delightful to have friends coming from distant quarters? "Is he not a man of complete virtue, who feels no discomposure though men may take no note of him?" 『⒈２』有子曰：“其为人也孝弟，而好犯上者，鲜矣；不好犯上，而好作乱者，未之有也。君子务本，本立而道生。孝弟也者，其为仁之本与！” The philosopher Yu said, "They are few who, being filial and fraternal, are fond of offending against their superiors. There have been none, who, not liking to offend against their superiors, have been fond of stirring up confusion. "The superior man bends his attention to what is radical. That being established, all practical courses naturally grow up. Filial piety and fraternal submission,-are they not the root of all benevolent actions?" 『⒈３』子曰：“巧言令色，鲜矣仁！” The Master said, "Fine words and an insinuating appearance are seldom associated with true virtue." 『⒈４』曾子曰：“吾日三省吾身——为人谋而不忠乎？于朋友交而不信乎？传不习乎？” The philosopher Tsang said, "I daily examine myself on three points:-whether, in transacting business for others, I may have been not faithful;-whether, in intercourse with friends, I may have been not sincere;-whether I may have not mastered and practiced the instructions of my teacher." 『⒈５』子曰：“道千乘之国，敬事而信，节用而爱人，使民以时。” The Master said, "To rule a country of a thousand chariots, there must be reverent attention to business, and sincerity; economy in expenditure, and love for men; and the employment of the people at the proper seasons." 『⒈６』子曰：“弟子，入则孝，出则弟，谨而信，凡爱众，而亲仁。行有余力，则以学文。” The Master said, "A youth, when at home, should be filial, and, abroad, respectful to his elders. He should be earnest and truthful. He should overflow in love to all, and cultivate the friendship of the good. When he has time and opportunity, after the performance of these things, he should employ them in polite studies." 『⒈７』子夏曰：“贤贤易色；事父母，能竭其力；事君，能致其身；于朋友交，言而有信。虽曰未学，吾必谓之学矣。”
Fédération Internationale Des Ingénieurs-Conseils 通用条件 General Conditions 1.一般规定 General Provisions 1.1 定义 Definitions 在包括专用条件和本通用条件的合同条件（“本合同条件”）中，以下措辞和用语的含义如下所述。除非上下文中另有要求，指当事人和当事各方的词包括公司和其它法律实体。 In the Conditions of Contract ("these Conditions"), which include Particular Conditions and these General Conditions, the following words and expressions shall have the meanings stated. Words indicating persons or parties include corporations and other legal entities, except where the context requires otherwise. 1.1.1 合同 1.1.1 The Contract 1.1.1.1“合同(Contract)”指合同协议书、中标函、投标函、本合同条件、规范、图纸、资料表、以及在合同协议书或中标函中列明的其它进一步的文件(如有时)。 1.1.1.1 "Contract" means the Contract Agreement, the Letter of Acceptance, the Letter of Tender, these Conditions, the Specification, the Drawings, the Schedules, and the further documents (if any) which are listed in the Contract Agreement or in the Letter of Acceptance. 1.1.1.2“合同协议书(Contract Agreement)”指第1.6款【合同协议】中所说明的合同协议(如有时)。 1.1.1.2 "Contract Agreement" means the contract agreement (if any) referred to in Sub-Clause 1.6 [Contract Agreement]. 1.1.1.3“中标函(Letter of Acceptance)”指雇主对投标文件签署的正式接受函，包括其后所附的备忘录(由合同各方达成并签定的协议构成)。在没有此中标函的情况下，“中标函”一词就指合同协议书，颁发或接收中标函的日期就指双方签订合同协议书的日期。 1.1.1.3 "Letter of Acceptance" means the letter of formal acceptance, signed by the Employer, of the Letter of Tender, including any annexed memoranda comprising agreements between and signed by both Parties. If there is no such letter of acceptance, the expression "Letter of Acceptance" means the Contract Agreement and the date of issuing or receiving the Letter of Acceptance means the date of signing the Contract Agreement. 1.1.1.4“投标函(Letter of Tender)”指名称为投标函的文件，由承包商填写，包括已签字的对雇主的工程报价。 1.1.1.4 "Letter of Tender" means the document entitled letter of tender, which was completed by the Contractor and includes the signed offer to the Employer for the Works. 1.1.1.5“规范(Specification)”指合同中名称为规范的文件，及根据合同规定对规范的增加和修改。此文件具体描述了工程。 1.1.1.5 "Specification" means the document entitled specification, as included in the Contract, and any additions and modifications to the specification in accordance with the Contract. Such document specifies the Works. 1.1.1.6“图纸(Drawings)”指合同中规定的工程图纸，及由雇主(或代表)根据合同颁发的对
各国国旗 Afghanistan Albania Algeria Andorra Angola Antigua Argentina Armenia 阿富汗阿尔巴尼亚阿尔及利亚安道尔安哥拉安提瓜阿根廷亚美尼亚 Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belgium 澳大利亚奥地利阿塞拜疆巴哈马巴林孟加拉巴巴多斯比利时 Belize Benin Bhutan Bolivia Botswana Brazil Brunei Bulgaria 伯里兹贝宁不丹玻利维亚博茨瓦纳巴西文莱保加利亚 BurkinaFaso Burundi Cameroon Canada CapeVerde C.A.R Chad Chile 布基纳法索布隆迪喀麦隆加拿大佛得角中非乍得智利 China Colombia Comoros Congo Costa Rica Cuba Cyprus Czech 中国哥伦比亚科摩罗刚果哥斯达黎加古巴塞浦路斯捷克 El Equatorial Estonia Denmark Dominica Dominican Ecuador Egypt Salvador 丹麦多米尼克多米尼加厄瓜多尔埃及萨尔瓦多赤道几内亚爱沙尼亚
Fiji Finland France Gabon Gambia Georgia Germany Ghana 斐济芬兰法国加蓬冈比亚乔治亚德国加纳 Greece Grenada Guatemala GuineaBissau Guinea Guyana Haiti Holy See 希腊格林纳达危地马拉几内亚比绍几内亚圭亚那海地梵蒂冈 Honduras Hungary Iceland India Idonesia Iran Iraq Ireland 洪都拉斯匈牙利冰岛印度印度尼西亚伊朗伊拉克爱尔兰 Israel Italy Jamaica Japan Jordan Kenya Kiribati Korea(N) 以色列意大利牙买加日本约旦肯尼亚基里巴斯朝鲜 Korea(S) Kuwait Laos Latvia LLebanon Lesotho Liberia Libya 韩国科威特老挝拉托维亚黎巴嫩莱索托利比里亚利比亚 Lithuania Madagascar Malawi Malaysia Maldives Mali Malta Man,Isle. 立陶宛马达加斯加马拉维马来西亚马尔代夫马里马耳他马恩岛 Mauritania Mauritius Mexico Monaco Mongolia Morocco Mozambique Namibia 毛里塔尼亚毛里求斯墨西哥摩纳哥蒙古摩洛哥莫桑比克纳米比亚
一、企业财务会计报表封面 FINANCIAL REPORT COVER 报表所属期间之期末时间点 Period Ended 所属月份 Reporting Period 报出日期 Submit Date 记账本位币币种 Local Reporting Currency 审核人 Verifier 填表人 Preparer 二、资产负债表 Balance Sheet 资产 Assets 流动资产 Current Assets 货币资金 Bank and Cash 短期投资 Current Investment 一年内到期委托贷款 Entrusted loan receivable due within one year 减：一年内到期委托贷款减值准备 Less: Impairment for Entrusted loan receivable due within one year 减：短期投资跌价准备 Less: Impairment for current investment 短期投资净额 Net bal of current investment 应收票据 Notes receivable 应收股利 Dividend receivable 应收利息 Interest receivable 应收账款 Account receivable 减：应收账款坏账准备 Less: Bad debt provision for Account receivable 应收账款净额 Net bal of Account receivable 其他应收款 Other receivable 减：其他应收款坏账准备 Less: Bad debt provision for Other receivable 其他应收款净额 Net bal of Other receivable 预付账款 Prepayment 应收补贴款 Subsidy receivable 存货 Inventory 减：存货跌价准备 Less: Provision for Inventory 存货净额 Net bal of Inventory 已完工尚未结算款 Amount due from customer for contract work 待摊费用 Deferred Expense 一年内到期的长期债权投资 Long-term debt investment due within one year 一年内到期的应收融资租赁款 Finance lease receivables due within one year 其他流动资产 Other current assets 流动资产合计 Total current assets 长期投资 Long-term investment 长期股权投资 Long-term equity investment 委托贷款 Entrusted loan receivable 长期债权投资 Long-term debt investment
激活(activate) 数组(array) 数组公式(array formula) 相关联的数据透视表(associated PivotTable report) 自动套用格式(autoformat) 坐标轴(axis) 基础地址(base address) “合并计算”表(consolidation table) 比较条件(comparison criteria) 比较运算符(comparison operator) 常量(constant) 单元格引用(cell reference) 当前区域(current region) 分类轴(category axis) 分类字段(category field) 复制区域(copy area) 计算列(calculated column) 计算项(calculated item) 计算字段（数据库）(calculated field) 计算字段（数据透视表）(calculated field) 列标题(column heading) 列标题(column heading) 列字段(column field) 条件(criteria) 条件窗格(criteria pane) 条件格式(conditional format) 图表工作表(chart sheet) 图表区(chart area) 修订记录(change history) 约束条件(constraints) 证书验证机构(certifying authority) 自定义计算(custom calculation) 垂直线(drop lines) 从属单元格(dependents) 明细数据(detail data) 默认工作表模板(default worksheet template) 默认工作簿模板(default workbook template) 默认启动工作簿(default startup workbook) 目标区域(destination area) 数据标签(data label) 数据标志(data marker) 数据表(data table) 数据表单(data form) 数据窗格(data pane)
1.Sales Agreement The agreement, (is) made in Beijing this eighth day of August 1993 by ABC Trading Co., Ltd., a Chinese Corporation having its registered office at Beijing, the People’ Repubic of China (hereinafter called “Seller”) and International Tradi ng Co., Ltd., a New York Corporation having its registered office at New York, N.Y., U.S.A. (hereinafter called “Buyer”). 2.WITNESSETH WHEREAS, Seller is engaged in dealing of (product) and desires to sell (product)to Buyer, and WHEREAS, Buyer desires to purchase(product) from Sellers, Now, THEREFORE, it is agreed as follows: 3.Export Contract This Contract is entered into this 5th day of August 1993 between ABC and Trading Co., Ltd. (hereinafter called “Seller”) who agrees to sell, and XYZ Trading Co., Ltd. (hereinafter called “Buyer”) who agrees to buy the following goods on the following terms and condition. 4.Non-Governmental Trading Agreement No. ＿＿This Agreement was made on the＿day of＿19＿, BETWEEN ＿ (hereinafter referred to as the Seller) as the one Side and ＿ (hereinafter referred to as the Buyer) as the one other Side. WHEREAS, the Seller has agreed to sell and the buyer has agreed to buy ＿ (hereinafter referred to as the Goods ) the quantity, specification, and price of which are provided in Schedule A. IT IS HEREBY AGREED AS FOLLOWS: 5.Contract For Joint-Operation Enterprise ＿＿ COMPANY LTD., a company duly organized under the Law of ＿＿ and having its registered office at (hereinafter called “Party A”) AND ＿＿ COMPANY LTD., a company duly organized under the Law of ＿＿ and having its registered office at (hereinafter called “Party B”) Party A and Party B (hereinafter referred to as the “Parties”) agree to jointly form a Co-operation Venture Company (hereinafter referred to as the “CVC”) in accordance with “the Laws of the People’s Republic of China on Joint Ventures Using Chinese and Foreign Investment” and the “Regulations for the Implementation of the Laws of the People’s Republic of China on Joint Ventures Using Chinese and Foreign Investment” and other applicable laws and regulations. 6.MODEL CONTRACT Contract No. Date: Seller: Signed at: Address: Cable Address: Buyer: Address: Cable Address: The Seller and the Buyer have agreed to conclude the following transactions according to the terms and conditions stipulated below: https://www.doczj.com/doc/20919993.html, of Commodity: 2.Specifications: 3.Quantity: 4.Unit Price: 5.Total Price: U.S.$: 6.Packing: 7.Time of Shipment: days after receipt of L/C. 8.Loading Port & Destination Port: From via to . 9.Insurance:
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合作合同 甲乙双方本着平等互利，协商一致的 原则，就甲方授权乙方在指定区域经 销甲方产品的有关事宜，达成如下协议： 第一条 合同双方保证自己是合法存在的法人 组织，具有经营与经销本合同指定产品的资格，并互换《营业执照》，《税务登记证》等有关证件的复印件。 第二条代理销售区域范围 1. 甲方授权乙方销售甲方产品的行 政区域为：奥地利； 2. 乙方同意作为甲方在上述指定区 域之代理商，并承诺全部履行本合同 项下之义务。 第三条合作方式 由甲方提供能源节电技术产品，由乙 方负责在奥地利进行推广、销售： a) 甲方提供的产品，应适于在奥地利 销售，并由缔约双方书面确定； b) 甲方对由自己提供的产品的使用， 负责为乙方进行人员培训； c) 甲方应在本合同规定的范围内向 奥地利WT或其指定的其它港口出口合作产品； d) 甲方应提供经乙方指定的优质可 销的能源节电技术产品； e) ）根据本合同合作的产品应采用专 Cooperation Contract On the basis of the principal of equality and mutual benefit, through friendly consultation, whereas Party A agrees to entrust Party B to sell the products of Party A in the appointed areas, now this presents witness that is hereby agreed between the parties hereto as follows. Article 1 Both parties hereto shall ensure their legal positions of corporate organizations and the qualification to sell the products as specified in this Contract. Both parties shall exchange the duplicated documentations of relevant certificates such as business license and tax registration certificate. Article 2 Distribution Area 1. The distribution area authorized by Party A to Party B is Austria; 2. Party B agrees to be the agent in the area mentioned above and undertake all the obligations under this Contract. Article 3 Cooperation Mode Party A shall provide energy resources electricity power saving / conservation technology products and Party B shall be responsible for the promotion and sales of the products: a) The products supplied by Party A shall be suitable for the sales in Austria and shall be confirmed by both parties hereto in written form; b) Party A shall be responsible for the training of the personnel of Party B for the use of the products supplied by Party A; c) Party A shall export the products to WT or other ports appointed by it within the scope as specified in this contract; d) Party A shall supply to the marketable resources electricity power saving / conservation technology products with high quality as specified by Party B; e) The products to be manufactured under this contract shall be specifically branded as being produced for the exclusive distribution by Party B in Austria; f) Party A shall have the exclusive rights to produce and supply the products under this contract to Party B and Party B shall have the exclusive right to receive the products made by Party A under this contract. Party A shall not transact any business with
纯干货，中英对照版，找资料可以用，当百科科普文看也是可以的！ 本来是自己需要用去查了几个词，结果越记越多QAQ 找东西度娘不靠谱大家都懂，谷歌必应随便哪个都比度娘好用 很多东西纯粹用中文也找不到，干脆把这些对照都整理了一下 以下英文一般需要配合一些更通用的词汇使用，不然找出来太泛 配合styel、art、design等自己的需求用词可以大大缩小搜索范围 木有细分，大概用空行隔了隔，也许会有重复的和手误 发现问题了我会随时更改网站版 所以发现问题了请留言或者微博私信给我就行~_(:зゝ∠)_） 【名词】 图案：patterns 图式：schemes 图解形式主义：diagrammatic formalism 写实主义：Realism 拟古主义：archaistic 自然主义：naturalism 背景：background 装饰文法（书名）：grammar of ornament 【地区】 希腊：hellenic 哥特：Gothic 巴洛克：Baroque 前希腊化：pre-hellenic 阿拉伯式：arabic 仿阿拉伯式：mock arabic 近东：Near Eastern 罗曼式：romanesque 古希腊+罗马流派：Greco-Roman school 远东：far east 【构成和形状】 编制：weaven
堆砌：built-up 点饰：spots 散点装饰：powdering 波浪状带饰图案：waved band pattern 分枝的基状图案：branching stem-work 连锁：interlocked 交错：counter changing 叠加：heaping 【图案】 铭文：inscriptions 螺旋纹：the spiral 十字纹：the cross 卍字纹：the swastika 准图画：quasi-pictorial 辫子图案：plaited pattern 叶饰图案：foliage-work 墨痕：blotted touch 斑状纹：splashed 大理石纹：marbled 叶脉纹：vening 木纹：grauning 图画式圆盘：picture-disks 茅尖形相：lance olate figwes 叶状空间填充纹饰：foliated space-fillings 条纹+方格：chequers 三叶饰：trefoil 圆叶饰：quatrefoil 五叶饰：cinquelfoil 叶形图形：foiled device 玫瑰花窗（叶形图案的极致）：rose-window 阿拉伯风格↓ 五角星形：pentagram 八角星形：eight-pinted star 十角星形：ten-pointed star 十二角星形：Twelve-pointed star 十六角星形：sixteen-pointed star 双重三角形：double triangle
历年政府工作报告中英文对照版和《经济学家》中英文对照版建议多看看，上面的习题最好都亲自做一下，三级没多大难度，充分准备应该可以通过 汉英翻译技巧的培养（translation competence development）应涉及以下内容： 一.要培养对英语的语感和悟性（language intuition – open and alert mind to pick up idioms, specific expressions, etc.）； 二.要培养对英语的判断能力和鉴赏能力（evaluation capacity – judgment）； 三.要培养对英语的洞察能力和剖析能力（power of observation – insight）； 四.要培养对英语细微特征的反应能力（linguistic nuances alertness）；- 五.要培养对社会文化和跨文化交流的敏感性（social-cultural sensitivity –cross-cultural awareness）； 六.要培养对英语和汉语之间差别的意识(sense of differences between Chinese and English)； 七.要培养对英语和汉语之间的辩证关系的认识(awareness of the dialectic relationship between Chinese and English)； 八.要培养对英语“洋为中用”的意识(“use things foreign to serve Chinese purposes”)； 九.要培养对英语“学以致用”的意识(apply what you have learned in your translation)； 十.要培养对翻译的多层次、多角度的立体思维方式(a multi-tier approach )。 十一.一名称职的翻译工作者必须懂得什么是翻译的真谛(a clear conception of what translation is)。 十二.一名优秀的翻译人员必须具有高屋建瓴的视角(great powers of conception)。 各种能力和意识的培养都需要加强翻译意识的锻炼： 第一：要对翻译的重要性有深刻的、充分的认识，翻译的对与错、好与坏有时会产生绝
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