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美国cGMP-中英文对照

PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN

MANUFACTURING, PROCESSING, PACKING, OR

HOLDING OF DRUGS; GENERAL

Sec. 210.1 Status of current good manufacturing practice regulations.

cGMP的法规地位。

(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.

在本部分及本章第211－226部分中所陈述的法规，为现行良好制造规范的最低要求，适用于药品制造、加工、包装或贮存中所采用的方法及所使用的设施或控制手段，以保证该药品符合《法案》对安全性的要求，具有其声称的或表明拥有的同一性和药物规格，并符合质量及纯度特征。

(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.

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本章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.

人类细胞、组织和细胞组织底物产品（HCT/Ps），根据本章§1271.3(d)的定义属药品（按照《法案》第505节递交的申请或按照《公共健康服务法案》第351节进行的生物制品许可申请接受审核）。从事该类药品回收、捐献者筛选、检验（包括捐献者检验）、加工、贮藏、贴标、包装或销售企业的所有者和经营者，除受本部分法规及本章第211－226部分约束外，还应受本章第1271部分的C子部和D子部陈述的捐献者合格性和适用的《现行良好组织操作规程》的约束。在药品制造、加工、包装或贮存过程中，如存在不符合本部分及本章第211—226部分、本章第1271部分的C子部或本章第1271部分的D子部中任何法规的情况，依据《法案》第501节(a)(2)(B)，将该HCT/P视为劣药，并且对该HCT/P及事故责任人采取相应监管措施。

Sec. 210.2 Applicability of current good manufacturing practice regulations.

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.

本部分及本章211—226适用于普通药品，本章600—680适用于人用生物制品，本章1271部分适用于人类的细胞、组织或是细胞组织底物产品(HCT/P)）属药品（按照《法案》第505节递交的申请或按照《公共健康服务法案》第351节进行的生物制品许可申请接受审核）的法规，它们之间应该是相互补充而不是相互取代，法规另有明确规定除外。在适用本部分法规和本章其它部分法规发生冲突的情况下，特别法规应替代普通法规适用于所涉及的药品。

(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 through 680 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.

如果一个人参与到了21CFR中相关法规的一些具体操作中，21CFR的211到226部分，600到680部分和1271部分，而不参与到其他部分的，这个人仅仅需要遵守他/她所涉及的相关操作的相关规范。

(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.

在本章312.21(a)部分描述的要调查研究第一阶段研究的药品要服从在21 U.S.C.

351(a)(2)(B)中的陈述的法定的要求。这种药物的生产免予21CFR第211部分法规的要求。然而，一旦这个要调研的新药可以被申请者应用到第二，三阶段的研究中，如本章

中312.21(b) and (c)描述的那样，或是药品已经合法上市，那前面所述的不一致并不适

用于一个要用到的调研新药的第一阶段的研究。如果要调研的新药已经在第二阶段和第

三阶段中应用或是药品已经合法上市了，那么药品的第一阶段的研究必须遵守211部分

的要求。

[69 FR 29828, May 25, 2004, as amended at 73 FR 40462, July 15, 2008]

[《联邦公报》69卷第29828页，2004年5月25日，联邦公报》71 卷第2462页修订，2006年1月17日]

Sec. 210.3 Definitions.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.

在联邦食品、药品及化妆品法201部分中包含的定义和解释、说明适用于本章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.

在联邦食品、药品及化妆品法201部分中包含的定义和解释、说明同样适用于本章211—226部分中的术语

(1)Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301et seq. ).

法案(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.

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.

组分(Component)指用于药品生产过程中的所有成份，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.

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.

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.

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。

(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.

活性成份(Active Ingredient)是指任何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。本术语包括那些在药品制造中发生化学变化并为了发挥其特定的活性或疗效而以一种修饰的形式存在于药品中的组份。

(8)Inactive ingredient means any component other than an active ingredient.

非活性成份(Inactive ingredient)指不同于“活性成份”的其他任何组分。

(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.

中间产品(In-process material)是指所有经制备、复合、混合或经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.

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.

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.

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.

药用物料(medicated feed)指在本章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 225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.

药用预混合料(medicated premix)指本章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.

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:

(i) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or

(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).

规格（Strength）

(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) 活性(效价)即根据适当的实验室检测或足够的临床研究可靠数据而得出的药品治疗活性(例如可表达为相对当于多少单位的标准物质)。

(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.

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.

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.

理论收率(Percentage of theoretical yield)指制造、加工或包装某种药品的任一适当阶段的实际产量与该阶段理论产量的比率，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).

接受标准(Acceptance criteria) 指与取样检验方法相联系的产品技术规定和接受/拒绝标准，诸如可接受的质量水平及不可接受的质量水平，这是对一批或一整批（或其它产出单元中方便表示的小集合）做出接受或拒绝的必要依据。

(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.

代表性样品(Representative sample)指一个样品包含若干单位（元）按合理的标准抽取（如随机取样法），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.

多项印刷贴标(Gang-printed labeling)指从物料表所演变来的贴标，上面印刷有一个以上的条目。

[《联邦公报》43卷第45076页，1978年9月29日，《联邦公报》51卷第7389页修订，1986年3月3日；《联邦公报》58卷第41353页，1993年8月3日；《联邦公报》73卷第51931页，2008年9月8日]

[43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993; 73 FR 51931, Sept. 8, 2008]

PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR

FINISHED PHARMACEUTICALS

Subpart A--General Provisions总则

§ 211.1 - Scope. 范围

§ 211.3 - Definitions. 定义

Subpart B--Organization and Personnel组织机构及人员

§ 211.22 - Responsibilities of quality control unit. 质量控制部门的职责

§ 211.25 - Personnel qualifications. 人员资质

§ 211.28 - Personnel responsibilities. 人员职责

§ 211.34 - Consultants. 顾问

Subpart C--Buildings and Facilities建筑和设备

§ 211.42 - Design and construction features. 设计与建造特征

§ 211.44 - Lighting. 照明

§ 211.46 - Ventilation, air filtration, air heating and cooling. 通风、空气过滤、空气加热与冷却

§ 211.48 - Plumbing. 管件

§ 211.50 - Sewage and refuse. 污水和废料

§ 211.52 - Washing and toilet facilities. 洗涤和盥洗设备

§ 211.56 - Sanitation. 卫生

§ 211.58 - Maintenance. 保养

Subpart D--Equipment设备

§ 211.63 - Equipment design, size, and location. 设备的设计、尺寸及位置

§ 211.65 - Equipment construction. 设备的建造

§ 211.67 - Equipment cleaning and maintenance. 设备的清洁和维护

§ 211.68 - Automatic, mechanical, and electronic equipment. 自动化设备、机械化设备和电子设备

§ 211.72 - Filters. 过滤器

Subpart E--Control of Components and Drug Product Containers and Closures成分、药品容器和密封件控制

§ 211.80 - General requirements. 总体要求

§ 211.82 - Receipt and storage of untested components, drug product containers, and closures. 未检验的成份、药品容器和密封件的接收与贮存

§ 211.84 - Testing and approval or rejection of components, drug product containers, and closures. 成份、药品容器和封口物品的试验、批准或拒收

§ 211.86 - Use of approved components, drug product containers, and closures. 批准的组分，药物的容器和密封件的应用

§ 211.87 - Retesting of approved components, drug product containers, and closures. 获准的组分、药品容器和密封件的复检.

§ 211.89 - Rejected components, drug product containers, and closures. 拒收的成份、

药品容器和密封件

§ 211.94 - Drug product containers and closures. 药品容器和密封件

Subpart F--Production and Process Controls生产和加工控制

§ 211.100 - Written procedures; deviations. 成文的规程、偏差

§ 211.101 - Charge-in of components. 成分的进料

§ 211.103 - Calculation of yield. 产量计算

§ 211.105 - Equipment identification. 设备鉴别

§ 211.110 - Sampling and testing of in-process materials and drug products. 中间体和药品的取样与检验

§ 211.111 - Time limitations on production. 生产时间限制

§ 211.113 - Control of microbiological contamination. 微生物污染的控制

§ 211.115 - Reprocessing. 返工

Subpart G--Packaging and Labeling Control包装和标签控制

§ 211.122 - Materials examination and usage criteria. 材料的检查和使用标准

§ 211.125 - Labeling issuance. 标签的发放

§ 211.130 - Packaging and labeling operations. 包装和标签操作

§ 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 人用非处方药（OTC）保险包装的要求

§ 211.134 - Drug product inspection. 药品检查

§ 211.137 - Expiration dating. 有效期

Subpart H--Holding and Distribution贮存和销售

§ 211.142 - Warehousing procedures. 入库程序

§ 211.150 - Distribution procedures. 销售程序

Subpart I--Laboratory Controls实验室控制

§ 211.160 - General requirements. 总体要求

§ 211.165 - Testing and release for distribution. 销售的检验与发放

§ 211.166 - Stability testing. 稳定性实验

§ 211.167 - Special testing requirements. 特别检验要求

§ 211.170 - Reserve samples. 样品保存

§ 211.173 - Laboratory animals. 实验动物

§ 211.176 - Penicillin contamination. 青霉素污染

Subpart J--Records and Reports记录和报告

§ 211.180 - General requirements. 总体要求

§ 211.182 - Equipment cleaning and use log. 设备清洁和使用记录

§ 211.184 - Component, drug product container, closure, and labeling records. 成份、药品容器、密封件及标签记录

§ 211.186 - Master production and control records. 主要生产和控制的记录

§ 211.188 - Batch production and control records. 批生产和控制记录

§ 211.192 - Production record review. 产品记录复查

§ 211.194 - Laboratory records. 实验记录

§ 211.196 - Distribution records. 销售记录

§ 211.198 - Complaint files. 投诉档案

Subpart K--Returned and Salvaged Drug Products退回的药品和回收处理§ 211.204 - Returned drug products. 药品的退回

§ 211.208 - Drug product salvaging.药品的挽回处理

PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR

FINISHED PHARMACEUTICALS

Subpart A--General Provisions 一般性法则

Sec. 211.1 Scope. 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.

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.

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，在本章的1271部分中，法规适用于人类细胞，组织和细胞组织为底物的产品（HCT/Ps）和一些药品，这些药品（服从联邦法律505部分的关于提交申请的复查部分或是公共卫生法的351部分的生物产品的申请许可）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。在本章的这部分和其他部分，或者是在本章的600到680的部分，或是1271部分法规有发生冲突的情况下，则可用存在争议药品的特定具体的法规来替代一般性的。

(c) Pending consideration of a proposed exemption, published in the Federal Register of 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.

在考虑经提议的，发表在1978年9月29日联邦注册表（FR）上的一项免除项是，若

产品及其所有成份是以人用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OTC药品是否按照GMP 的要求生产、加工、包装和贮存。

[43 FR 45077, Sept. 29, 1978, as amended at 62 FR 66522, Dec. 19, 1997; 69 FR 29828, May 25, 2004]

Sec. 211.3 Definitions.

The definitions set forth in 210.3 of this chapter apply in this part.

本章210?3中解释的定义适用于本部分

Subpart B--Organization and Personnel 组织机构和人员

Sec. 211.22 Responsibilities of quality control unit. 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.

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.

质量控制部门要可以获得足够的实验室检验设备用于批准（或拒收）各种成份、药品容器、密封件、包装材料及中间体。

(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.

本部门有批准或驳回影响药品的均一性、规格、质量和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.

适用于本部门的职责与程序，应成文字材料，并应遵循执行。

Sec. 211.25 Personnel qualifications. 人员资质

(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.

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，完成委派的各项任务。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。邀请有资质的人员指导，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.

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、规格、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.

有足够人数的合格人员进行和监督每种药品的生产、加工、包装或仓贮的。

Sec. 211.28 Personnel responsibilities. 人员职责

(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

从事药品生产、加工、包装或仓贮的人员，应穿着适合于其履行职责的清洁衣服。按需

要，头部、脸部、手部、臂部要戴上保护性的装置，防止药物受污染。

(b) Personnel shall practice good sanitation and health habits.

人员要保持良好的个人卫生和健康。

(c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.

只有监督人员授权的人员可以进入限制区域的建筑物和设施。

(d) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

任何人，在任何时间（无论是通过医学检查或是监管观察出），明显地表现出有可能影响药品安全性和质量的疾病或开放性损伤，应避免接触各种成份、药品容器、包装设备、密封件、中间体和最终产品，直至状况改善或是相关权威的监督人员认为不会对药品安全性和质量有危害。所有的人员都要被告知如果发生任何可能对药品产生不良影响的健康状况，都要向相关的监督人员报告。

Sec. 211.34 Consultants. 顾问

Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.

顾问应对药品生产、加工、包装或仓贮提出建议，他们要受过足够的教育、培训，且有丰富的实践经验，来对他们在行的领域的问题提出意见。有关他们的姓名、地址、任何的顾问资格证明及服务形式等履历资料要保存。

Subpart C--Buildings and Facilities

Sec. 211.42 Design and construction features. 设计与建造特征

(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.

任何用于某类药品生产、加工、包装或贮存的厂房或建筑群，大小要适宜，结构与位置要使其易于清洁、保养、适合操作。

(b) Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.

建筑物有足够空间来有条理地安装设备和放置材料，避免不同类的成份、药品容器、密封件、标签、中间体或药品等相互混放，防止污染。通过厂房的上述物料其流向在设计时要防止污染。

(c) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mixups during the course of the following procedures:

操作应在明确规定的、大小适中的区域内进行。在下列公司的操作过程中，操作要分开，在特定的区域或其他控制系统中进行，这个对于防止污染或是混淆是必要的。

(1) Receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging;

发放给生产或包装前，由质量控制部门取样、检测和检查药品的成份、容器、密封件及标签，监督接收、鉴别、贮存及拒收的过程。

(2) Holding rejected components, drug product containers, closures, and labeling before disposition;

在处理前，拒收的成份、药品容器、密封件及标签的贮存过程；

(3) Storage of released components, drug product containers, closures, and labeling; 已发放的成份、药品容器、密封件及标签的贮存过程；

(4) Storage of in-process materials;

中间体的贮存；

(5) Manufacturing and processing operations;

生产与加工操作；

(6) Packaging and labeling operations;

包装和贴标签操作；

(7) Quarantine storage before release of drug products;

药品发放前的隔离贮存；

(8) Storage of drug products after release;

发放后药品的贮存；

(9) Control and laboratory operations;

控制室与实验室操作；

(10) Aseptic processing, which includes as appropriate:

无菌操作及有关适当操作；

(i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable;

地板、墙壁和天花板平滑、坚硬、表面易清洁；

(ii) Temperature and humidity controls;

温度与湿度控制；

(iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar ;

空气经高效过滤器、在正压下过滤、层流或非层流均可；

(iv) A system for monitoring environmental conditions;

环境监测系统；

(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;

创造无菌环境、房间和设备清洁、消毒系统；

(vi) A system for maintaining any equipment used to control the aseptic conditions.

控制无菌环境的设备维修系统；

(d) Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use. 青霉素生产、加工及包装设备与生产其他人用药品的设备分开；

[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]

Sec. 211.44 Lighting 照明.

Adequate lighting shall be provided in all areas. 所有地区均须提供充足的照明

Sec. 211.46 Ventilation, air filtration, air heating and cooling.

通风、空气过滤、空气加热与冷却

(a) Adequate ventilation shall be provided. 提供足够的通风

(b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.

提供足够能控制空气正压、微生物、灰尘、温度和湿度的设备，适应药品生产、加工、包装和贮存需要。

(c) Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.

空气过滤系统，包括预过滤器和微粒物质空气过滤器是用来在合适情况过滤空气送至生产区，如果空气是再循环到生产区，应测量尘埃含量，控制从生产区带来的尘埃。在生产区、生产中发生空气污染，应以排气系统或其他系统充分抽出空气，控制污染。

(d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use.

青霉素生产、加工和包装的空气输送系统应与其他人用药品的空气输送系统完全分开。Sec. 211.48 Plumbing. 管件

(a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards shall not be permitted in the potable water system.

在持续正压下，应对药品无污染的管道系统内供应饮用水，管道系统内应没有可能导致药品污染的缺陷。饮用水应符合环境保护机构制订的“基本饮用水条例”标准（40CFR141部分）。不符合该标准的水，不许进入水系统。

(b) Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage.

排水设备应有足够的大小，可直接连接排水管及安装防止虹吸倒流的空气破坏设备或其他机械设备。

[43 FR 45077, Sept. 29, 1978, as amended at 48 FR 11426, Mar. 18, 1983]

Sec. 211.50 Sewage and refuse. 污水和废料

Sewage, trash, and other refuse in and from the building and immediate premises shall

be disposed of in a safe and sanitary manner.

来自水厂和附近建筑物或在建筑内的污水、垃圾及其他废料，用安全、卫生的方法处理

Sec. 211.52 Washing and toilet facilities洗涤和盥洗设备.

Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accesible to working areas.

提供洗涤和盥洗设备，包括热、冷水、肥皂、清洁剂、空气干燥器、专用毛巾和干净的进入工作区域的厨卫设备。

Sec. 211.56 Sanitation. 卫生

(a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.

所有用作药品生产、加工、包装及贮存的建筑应保持清洁、卫生的环境，这种建筑不受啮齿动物、鸟类及其他害虫侵害扰（实验动物除外）。垃圾和有机废料，及时以卫生的方法控制处理。

(b) There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.

填写分配卫生清洁任务的详细的清洁项目、方法、设备、用于清洁厂房和设施的材料的一览表，这些内容要依照执行。

(c) There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).

填写适用的杀鼠剂、杀昆虫剂、杀真菌剂、熏蒸剂、去垢剂和消毒剂一览表。这个文件要设计成是防止这些物品对设备、成份、药品容器密封件、包装材料、标签或药品污染。除依据联邦杀虫剂、杀真菌剂及杀鼠剂法规（7U.S.C135）已登记和使用的品种外，其他的杀虫剂、杀真菌剂及杀鼠剂不能使用。

(d) Sanitation procedures shall apply to work performed by contractors or temporary

employees as well as work performed by full-time employees during the ordinary course of operations.

卫生程序要在临时承包人和临时雇员的工作中应用，同时也要在全职工作的雇员日常操作中应用。

Sec. 211.58 Maintenance. 保养

Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.

任何用于药品生产、加工、包装或贮存的建筑应保持良好保养状态。

Subpart D--Equipment设备

Sec. 211.63 Equipment design, size, and location. 设备的设计、尺寸及位置

Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

药品生产、加工、包装或贮存的设备，设计合理，大小适当，布置合理，便于操作、清洁和保养。

Sec. 211.65 Equipment construction. 设备制造

(a) Equipment shall be constructed so that surfaces that contact components,

in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

设备的制造要使表面与各种中间体材料或药品成品接触，不产生反应、添加和吸附作用。保证在官方的和其他的设立的要求中，药品的安全性、均一性、效价或含量、质量或纯度不发生改变。

(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

操作所需之物质，如润滑剂、冷却剂等不能接触组分、药品成品的容器、封口物品、中间体和药品，保证在官方的和其他的设立的要求中，药品的安全性、均一性、效价或含量、质量或纯度不发生改变。

Sec. 211.67 Equipment cleaning and maintenance. 设备清洁与保养

(a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent

malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

相隔一定时间，对设备与工具进行清洁、保养和消毒，防止出故障与污染，影响药品的安全性、均一性、效价或含量、质量或纯度，超出了官方的和其他的设立的要求。

(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:

制订并执行设备的清洁维护，包括在药品生产、加工包装或贮存设备的工具的清洁和保养的文字程序。这些程序包括，但不限于以下内容：

(1) Assignment of responsibility for cleaning and maintaining equipment;

分配清洁、保养任务

(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;

保养和清洁细目一览表，包括清洁的日程；

(3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;

详细说明用于清洁和保养的设备、物品和方法。拆卸和装配设备的方法必须保证适合清洁和保养的要求；

(4) Removal or obliteration of previous batch identification;

除去或擦去前批遗留物的鉴定；

(5) Protection of clean equipment from contamination prior to use;

已清除了污染的清洁设备的保护；

(6) Inspection of equipment for cleanliness immediately before use.

使用前检查清洁的设备；

保留保养、清洁、消毒的记录。按211?180及211?182的说明检查。

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51931, Sept. 8, 2008]

Sec. 211.68 Automatic, mechanical, and electronic equipment.

自动化设备、机械化设备和电子设备

(a) Automatic, mechanical, or electronic equipment or other types of equipment,

中英文对照版

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》中英文对照版

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。”

美国50个州名中英文对照

美国州名美国州名英文州名简写和简称首府首府英文名阿拉巴马州Alabama AL 蒙哥马利Montgomery 阿拉斯加州Alaska AK 朱诺Juneau 阿利桑那州Arizona AZ 菲尼克斯Phoenix 阿肯色州Arkansas AR 小石城Little rock 加利福尼亚州California CA 萨克拉门托Sacramento 科罗拉多州Colorado CO 丹佛Denver 康涅狄格州Connecticut CT 哈特福德Hartford 特拉华州Delaware DE 多佛Dover 佛罗里达州Florida FL 塔拉哈西Tallahassee 乔治亚州Georgia GA 亚特兰大Atlanta 夏威夷州Hawaii HI 檀香山火努鲁鲁Honolulu 爱达荷州Idaho ID 博伊西Boise 伊利诺斯州Illinois IL 斯普林菲尔德Springfield 印第安纳州Indiana IN 印第安纳波利斯Indianapolis 爱荷华州Iowa IA 得梅因Des Moines 堪萨斯州Kansas KS 托皮卡Topeka 肯塔基州Kentucky KY 法兰克福Frankfort 路易斯安那州Louisiana LA 巴吞鲁日Baton Rouge 缅因州Maine ME 奥古斯塔Augusta 马里兰州Maryland MD 安纳波利斯Annapolis 马萨诸塞州Massachusetts MA 波士顿Boston 密歇根州Michigan MI 兰辛Lansing 明尼苏达州Minnesota MN 圣保罗St. Paul 密西西比州Mississippi MS 杰克逊Jackson 密苏里州Missouri MO 杰斐逊城Jefferson City 蒙大拿州Montana MT 海伦娜Helena 内布拉斯加州Nebraska NE 林肯Lincoln 内华达州Nevada NV 卡森城Carson City 新罕布什尔州 New hampshire NH 康科德Concord 新泽西州New jersey NJ 特伦顿Trenton 新墨西哥州New mexico NM 圣菲Santa Fe 纽约州New York NY 奥尔巴尼Albany 北卡罗来纳州North Carolina NC 纳罗利Raleigh 北达科他州North Dakota ND 俾斯麦Bismarck 俄亥俄州Ohio OH 哥伦布Columbus 俄克拉荷马州Oklahoma OK 俄克拉何马城Oklahoma City 俄勒冈州Oregon OR 塞勒姆Salem 宾夕法尼亚州Pennsylvania PA 哈里斯堡Harrisburg 罗得岛州Rhode island RL 普罗维登斯Providence

美国五十个州名称、音标、地图

美国五十州名称州名英文音标简州名英文音标简亚拉巴马州Alabama [,?l?'b?m?] AL 阿拉斯加州Alaska [?'l?sk?]AK 亚利桑那州Arizona [,?ri'z?un?] AZ 阿肯色州Arkansas ['ɑ:k?ns?:]AR 加利福尼亚州California [,k?li'f?:nj?] CA 科罗拉多州Colorado [,k?l?'rɑ:d?u]CO 康涅狄格州Connecticut [k?'netik?t] CT 特拉华州Delaware ['del?w??]DE 佛罗里达州Florida ['fl?rid?] FL 佐治亚州Georgia ['d??:d?j?]GA 夏威夷州Hawaii [h?'waii:] HI 爱达荷州Idaho ['aid?h?u]ID 伊利诺伊州Illinois [,ili'n?i(z)] IL 印第安纳州Indiana [,indi'?n?]IN 艾奥瓦州Iowa ['ai?w?] IA 堪萨斯州Kansas ['k?nz?s]KS 肯塔基州Kentucky [ken't?ki] KY 路易斯安那Louisiana [lu:,i:zi'?n?]LA 缅因州Maine [mein] ME 马里兰州Maryland ['mε?ril?nd]MD 马萨诸塞州Massachusetts [,m?s?'t?u:sits] MA 密歇根州Michigan ['mi?ig?n]MI 明尼苏达州Minnesota [,mini's?ut?] MN 密西西比州Mississippi [,misi’sipi]MA 密苏里州Missouri [mi'zu?ri] MO 蒙大拿州Montana [m?n't?n?]MT 内布拉斯加州Nebraska [ni'br?sk?] NE 内华达州Nevada [ni'v?d?]NV 新罕布什尔州New Hampshire [nju: 'h?mp??] NH 新泽西州New jersey [nju: 'd??:zi]NJ 新墨西哥州New Mexico [nju: 'meksik?u] NM 纽约州New York [nju:j?:k]NY 北卡罗来纳州North Carolina [n?:θ ,k?r?'lain?] NC 北达科他州North Dakota [n?:θ d?'k?ut?]ND 俄亥俄州Ohio [?u'hai?u] OH 俄克拉何马Oklahoma [?ukl?'h?um?]OK 俄勒冈州Oregon ['?riɡ?n]OR 宾夕法尼亚Pennsylvana [pensil'veinj?] PA 罗得岛州Rhode Island [r?ud,'ail?nd] RL 南卡罗来纳州South Carolina [sauθ ,k?r?'lain?]SC 南达科他州South Dakota [sauθ d?'k?ut?] SD 田纳西州Tennessee [,teni'si:]TN 德克萨斯州Texas ['teks?s] TX 犹他州Utah ['ju:ta:]UT 佛蒙特州Vermont [v?:'m?nt] VT 弗吉尼亚州Virginia [v?(:)'d?inj?]VA 华盛顿州Washington ['w??i?t?n] WA 西弗吉尼亚州West Virginia [west v?(:)'d?inj?]WV 威斯康星州Wisconsin [wis'k?nsin] WI 怀俄明州Wyoming [wai'?umi?]WY 华盛顿特区Washington D.C. ['w??i?t?n di ci]

条款中英文对照版

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美国50州中英文名称对照表.

美国50州中英文名称对照表 Alabama 阿拉巴马（AL）* Alaska 阿拉斯加（AK）Arizona 亚利桑那（AZ）Arkansas 阿肯色（AR）California 加利福尼亚（CA）Colorado 科罗拉多（CO）Connecticut 康乃狄格（CT）Delaware 特拉华（DE）Florida 佛罗里达（FL）Georgia 佐治亚（GA）Hawaii 夏威夷（HI）Idaho 爱达荷（ID）Illinois 伊利诺斯（IL）Indiana 印第安纳（IN）Iowa 衣阿华（IA）Kansas 堪萨斯（KS）Kentucky 肯塔基（KY）Louisiana 路易西安那（LA）Maine 缅因（ME）Maryland 马里兰（MD）Massachusetts 马萨诸塞（MA）Michigan 密西根（MI）Minnesota 明尼苏达（MN）Mississippi 密西西比（MS）Missouri 密苏里（MO）Montana 蒙大拿（MT）Nebraska 内布拉斯加（NE）Nevada 内华达（NV）New Hampshire 新罕布什尔（NH）New Jersey 新泽西（NJ）New Mexico 新墨西哥（NM）New York 纽约（NY）North Carolina 北卡罗来纳（NC）North Dakota 北达科他（ND）Ohio 俄亥俄（OH）Oklahoma 俄克拉荷马（OK）Oregon 俄勒冈（OR）Pennsylvania 宾夕法尼亚（PA）Rhode Island 罗德岛（RI）South Carolina 南卡罗来纳（SC）South Dakota 南达科他（SD）Tennessee 田纳西（TN）

各国国旗 (中英文对照版)

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

中英文对照版财务报表

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

美国50个州名中英文对照

英文版EXCEL中英文对照

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)

美国各州时差

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美国50个州名中英文对照之欧阳光明创编

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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.wendangku.net/doc/3f15514405.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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