21CFR211中英文对照版(SMART)

PART 211 211部分

- CURRENT GOOD MANUFACTURING PRACTICE FOR

—制剂药品的CGMP

FINISHED PHARMACEUTICALS

Subpart A--General Provisions A.总 则

§211.1 - Scope.211?1范围

§211.3 - Definitions.211?3定义

Subpart B--Organization and Personnel B．组织与人员

§211.22 - Responsibilities of quality control unit.211?22质量控制部门的职责

§211.25 - Personnel qualifications.211?25人员资格

§211.28 - Personnel responsibilities.211?28人员职责

§211.34 - Consultants.211?34顾问

Subpart C--Buildings and Facilities C．厂房和设施

§211.42 - Design and construction features.211?42设计与建造特征

§211.44 - Lighting.211?44照明

§211.46 - Ventilation, air filtration, air heating and211?46通风、空气过滤、空气加热与冷却

§211.48 - Plumbing.211?48管件

§211.50 - Sewage and refuse.211?50污水和废料

§211.52 - Washing and toilet facilities.211?52洗涤和盥洗设备

§211.56 - Sanitation.211?56卫生

§211.58 - Maintenance.211?58保养

Subpart D--Equipment D．设备

§211.63 - Equipment design, size, and location.211?63设备的设计、尺寸及位置

§211.65 - Equipment construction.211?65设备构造

§211.67 - Equipment cleaning and maintenance.211?67设备清洁与保养

§211.68 - Automatic, mechanical, and electronic

211?68自动化设备、机械化设备和电子设备equipment.

§211.72 - Filters.211?72过滤器

Subpart E--Control of Components and Drug

E．成分、药品容器和密封件控制

Product Containers and Closures

§211.80 - General requirements.211?80总要求

§211.82 - Receipt and storage of untested

211?82未检验的成份、药品容器和密封件的接收与贮存components, drug product containers, and closures.

§211.84 - Testing and approval or rejection of

211?84成份、药品容器和密封件的试验、批准或拒收components, drug product containers, and closures.

§211.86 - Use of approved components, drug product

211?86获准的成份、药品容器和密封件的使用containers, and closures.

§211.87 - Retesting of approved components, drug

211?87获准的成份、药品容器和密封件的复检product containers, and closures.

§ 211.89 - Rejected components, drug product

211?89拒收的成份、药品容器和密封件containers, and closures.

§ 211.94 - Drug product containers and closures.211?94药品密封容器和密封件

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

§211.100 - Written procedures; deviations.211?100成文的规程、偏差

§211.101 - Charge-in of components.211?101成分的控制

§211.103 - Calculation of yield.211?103 产量计算

§211.105 - Equipment identification.211?105设备鉴别

§211.110 - Sampling and testing of in-process

211?110中间体和药品的取样与检验materials and drug products.

§211.111 - Time limitations on production.211?111生产时间限制

§211.113 - Control of microbiological contamination.211?113微生物污染的控制

§211.115 - Reprocessing.211?115返工

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

§211.122 - Materials examination and usage criteria.211?122材料的检查和使用标准

§211.125 - Labeling issuance.211?125标签的发放

§211.130 - Packaging and labeling operations.211?130包装和贴签操作

§211.132 - Tamper-evident packaging requirements

211?132人用非处方药（OTC）保险包装的要求for over-the-counter (OTC) human drug products.

§211.134 - Drug product inspection.211?134药品检查

§ 211.137 - Expiration dating.211?137有效期

Subpart H--Holding and Distribution H．贮存和销售

§ 211.142 - Warehousing procedures.211?142入库程序

§ 211.150 - Distribution procedures.211?150销售程序

Subpart I--Laboratory Controls I?实验室控制

§ 211.160 - General requirements.211?160总要求

§ 211.165 - Testing and release for distribution.211?165销售前的检验与发放

§ 211.166 - Stability testing.211?166稳定性试验

§211.167 - Special testing requirements.211?167特别检验要求

§ 211.170 - Reserve samples.211?170留样

§ 211.173 - Laboratory animals.211?173实验动物

§ 211.176 - Penicillin contamination.211?176青霉素污染

Subpart J--Records and Reports J．记录和报告

§ 211.180 - General requirements.211?180总要求

§ 211.182 - Equipment cleaning and use log.211?182设备清洁和使用记录

§ 211.184 - Component, drug product container,

211?184成份、药品容器、密封件及标签记录closure, and labeling records.

§ 211.186 - Master production and control records.211?186主要生产和控制的记录

§ 211.188 - Batch production and control records.211?188批生产和控制记录

§ 211.192 - Production record review.211?192产品记录复查

§ 211.194 - Laboratory records.211?194实验室记录

§ 211.196 - Distribution records.211?196销售记录

§ 211.198 - Complaint files.211?198客户投诉档案

Subpart K--Returned and Salvaged Drug Products K．退货的药品和回收处理

§ 211.204 - Returned drug products.211?204退货的药品

§ 211.208 - Drug product salvaging.211?208 药品的回收利用

Subpart A-General Provisions A.总 则§ 211.1 Scope211?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, and in parts 600 through 680 of this

chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question （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 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 （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。

§ 211.3 Definitions.211?3定义

The definitions set forth in § 210.3 of this chapter

apply in this part.

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

§ 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 （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质量标准的职责。

(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。

§ 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 (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 (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)有足够数量执行和监督每种药品的生产、加工、包装或仓贮的合格人员。

§ 211.28 Personnel responsibilities.211?28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.(a)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、臂部应外罩，防止药物受污染

(b) Personnel shall practice good sanitation and

health habits.

(b)人员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.(c)未经监督人员允许，其他人员不能进入限制进入的建筑物和设施。

(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.(d)任何人，在任何时间，明显地表现出现有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，直至恢复或由资质的医务人员确认不会危害到药品的安生和质量。所有人员应受教育知道，应向负责人报告对药品有不利影响的健康情况。

§ 211.34 Consultants.211?34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.为了对问题提出意见，聘请顾问。顾问应对药品生产、加工、包装或仓贮提出建议，他们受过足够的教育、培训，且有丰富的实践经验。保留他们的姓名、地址、任何的顾问资格证书及服务形式等履历资料。

Subpart C-Buildings and Facilities C．厂房和设施

§ 211.42 Design and construction features.211?42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 (a)任何用于某类药品生产、加工、包装或贮存的厂房或建筑群，大小适宜，结构与位置使其易于清洁、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.(b)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 for the firm's operations to prevent contamination or mixups as follows:(c)操作应在明确规定的、大小适中的地区内进行。这些地区按规定各自分隔开，以防止污染。下列操作须在单独的地区内进行：

(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 (1)发放给生产或包装前，质量控制部门取样期间，成份、药品容器、密封件及标签的签收、鉴别、贮存及拒收区域。

(2) Holding rejected components, drug product containers, closures, and labeling before disposition;(2)在处理前，拒收的成份、药品容器、密封件及标签的贮存。

(3) Storage of released components, drug product

containers, closures, and labeling;

(3)已放行的成份、药品容器、密封件及标签的贮存。

(4) Storage of in-process materials;(4)中间体的贮存。

(5) Manufacturing and processing operations;(5)生产与加工操作。

(6) Packaging and labeling operations;(6)包装和贴标签操作。

(7) Quarantine storage before release of drug(7)药品放行前的待验隔离贮存。

(8) Storage of drug products after release;(8)放行后药品的贮存。

(9) Control and laboratory operations;(9)控制室与实验室操作。

(10) Aseptic processing, which includes as(10)无菌操作，包括如下适当的

(I) Floors, walls, and ceilings of smooth, hard

surfaces that are easily cleanable;

（Ⅰ）地板、墙壁和天花板平滑、坚硬、表面易清洁；(ii) Temperature and humidity controls;（Ⅱ）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;（Ⅲ）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;（Ⅳ）环境监测系统；

(v) A system for cleaning and disinfecting the room

and equipment to produce aseptic conditions;

（Ⅴ）创造无菌环境的房间和设备清洁、消毒系统；(vi) A system for maintaining any equipment used to

control the aseptic conditions.

（Ⅵ）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.（d）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

§ 211.44 Lighting.211?44照明

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

§ 211.46 Ventilation, air filtration, air heating and

cooling.

211?46通风、空气过滤、空气加热与冷却

(a) Adequate ventilation shall be provided.(a)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.(b)提供足够能控制空气正压、微生物、尘粒、温度和湿度的设备，适应药品生产、加工和贮存需要。

(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.(c)空气过滤系统，包括预过滤器和微粒物质空气过滤器。空气经过滤才送至生产区，如果空气是再循环到生产区，应控制从生产区带来的尘埃。生产中发生空气污染生产区，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 (d)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。

§ 211.48 Plumbing.211?48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.(a)饮用水应在持续正压下、对药品无污染的管道系统内供。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-(b)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。（43FR45077，1978年9月29日，修正于48FR11426，1983年3

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

18, 1983]

§ 211.50 Sewage and refuse.211?50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.来自附近建筑物的污水、垃圾及其他废料，用安全、卫生的方法处理。

§ 211.52 Washing and toilet facilities.211?52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 accessible to working areas.提供洗涤和盥洗设备，包括热、冷水，肥皂或清洁剂，空气干燥器或专用毛巾，及干净的盥洗设备，以便于进入进行工作区。

§ 211.56 Sanitation.211?56 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.(a)所有用作药品生产、加工、包装及贮存的厂房应保持清洁、卫生的环境，且不受啮齿动物、鸟类及其他害虫侵害扰（实验动物除外）。垃圾和有机废料，定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.(b)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,应有成文规定。

(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)(c)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，应有成文规定。防止这些操作对设备、成份、药品容器密封件、包装材料、标签或药品产生污染。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.(d) 消毒程序应适用于合同雇用或临时雇员，如同全职雇员一样在普通例行的操作时执行。

§ 211.58 Maintenance.211?58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、包装或贮存的厂房保持良好状态。

Subpart D-Equipment D．设备

§ 211.63 Equipment design, size, and location.211?63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 药品生产、加工、包装或贮存设备，设计合理，大小适当，布置合理，便于操作、清洁和保养。

§ 211.65 Equipment construction.211?65设备构造(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.(a)设备表面与各种成份、中间体或药品接触，不会发生改变药品的安全性、均一性、效价或含量、质量或纯度的化学反应或吸收作用。

(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 (b)操作所需的物质，如润滑剂、冷却剂等不能进入设备里，与成份、药品容器、密封件、中间体或药品接触，保证药品的安全性、均一性、效价或含量、质量或纯度不变。

§ 211.67 Equipment cleaning and maintenance.211?67设备清洁与保养(a) Equipment and utensils shall be cleaned,

maintained, and sanitized 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 (a)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。

(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 (b)制订药品生产、加工包装或贮存设备（包括用具）的清洁和保养文字程序，并执行。这些程序包括，但不一定限于以下内容；

(1) Assignment of responsibility for cleaning and

maintaining equipment;(1)分配清洁、保养任务。

(2) Maintenance and cleaning schedules, including,

where appropriate, sanitizing schedules;(2)保养和清洁细目一览表。

(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;(3)详细说明用于清洁和保养时使用的方法、设备、物质。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(4)除去或擦去前批遗留物的鉴定。

(5) Protection of clean equipment from contamination

prior to use;(5)已清除了污染的清洁设备的保护。

(6) Inspection of equipment for cleanliness immediately

before use.(6)使用前清洁设备的检查。

(7) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in §§ 211.180 and 211.182.(7)保留保养、清洁、消毒的记录。按211?180及211?182的说明检查。

§ 211.68 Automatic, mechanical, and electronic

equipment.

211?68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, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and

i i h ll b i i d (a)用于药品生产、加工、包装和贮存的自动化、机械化或电子包括计算机或其它类型的设备。按惯例，对其设计之成文条款作标定、检查或核对，保证其工作性能良好。保留检查、标定、核对等文字记录。(a)用于药品生产、加工、包装和贮存的自动化、机械化或电子包括计算机或其它类型的设备。按惯例，对其设计之成文条款作标定、检查或核对，保证其工作性能良好。保留检查、标定、核对等文字记录。

(b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas

or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures or loss shall be maintained (b)对保障重要生产变化的计算机或有关系统进行操作培训。操作记录或其他记录只能由被认可的人员制订。向计算机或有关系统输入或从中输出的各种方案、其他记录或资料，应核查其准确性。输入计算机或关系统内的档案资料，除与实验室共同分析计算的结果可消除外，其他的应保留。文字记录与相应的证明资料一起保存。事先设计好的硬件复制品或多台选择系统，如复印件、磁带或微型胶卷等，保证其副本资料正确、可靠及完整。出现资料改动、非人为消除或遗失时，应维修。

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

20, 1995]

§ 211.72 Filters.211?72过滤器Filters for liquid filtration used in the manufacture,

processing, or packing of injectable drug products

intended for human use shall not release fibers into

such products. Fiber-releasing filters may not be used in

the manufacture, processing, or packing of these injectable drug products unless it is not possible to manufacture such drug products without the use of such filters. If use of a fiber-releasing filter is necessary,an additional non-fiber-releasing filter of 0.22 micron maximum mean porosity (0.45 micron if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of particles in the injectable drug https://www.wendangku.net/doc/e21920578.html,e of an asbestos-containing filter, with or without subsequent use of a specific non-fiber-releasing filter, is permissible only upon submission of proof to the appropriate bureau of the Food and Drug Administration that use of a non-fiber-releasing filter will or is likely to compromise the safety 用于生产、加工的液体过滤器或人用注射药品的包装材料不许释放出的纤维进入产品。除非不得已，不应在生产、加工中使用释放纤维的过滤器或注射药品的包装材料。若必须使用一种能释放纤维素的过滤器，最后应使用一非释放纷纷物、平均最大孔径为0.22μm(如实际生产条件限制，可用0.45μm)的附加过滤器过滤，降低注射剂内微粒量。使用含石棉的过滤器最后用或不用特殊非释放纤维过滤器均可以，但要根据FDA有关部门提供的该非释放纤维过滤器会或可能损害注射剂的安全性和有效性的证据而定。

Subpart E-Control of Components and Drug

Product Containers and Closures

E．成份、药品容器和密封件控制§ 211.80 General requirements.211?80总要求

(a) There shall be written procedures describing in

sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.(a)有文字详细说明成份、药品容器、密封件的签收、鉴定、贮存、装运取样、检验和批准或拒收程序，并遵循。

(b) Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination.(b)成份、药品容器和密封件应专人管理和在防止污染的环境下贮存。

(c) Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection.(c)药品容器的包装袋或包装箱或密封件应离地面放置保持适当间隔，以便清洁和检查。

(d) Each container or grouping of containers for components or drug product containers, or closures

shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).(d)用明显批号代码对已接收的每次到货的成份、药品容器或密封件加以区别。此批号代码用于记录每批货的处理。每批货按其状态应有适当标识，如待验、批准或拒收。

§ 211.82 Receipt and storage of untested

components, drug product containers, and

211?82未检验的成份、药品容器和密封件的接收与贮存(a) Upon receipt and before acceptance, each container

or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.(a)接收时和验收前，对每个或编组的成份容器、药品容器和密封件进行目检，检查标签与内容物是否一致、容器损坏或拆封和污染等情况

(b) Components, drug product containers, and closures

shall be stored under quarantine until they have been tested or examined, as appropriate, and released. Storage within the area shall conform to the (b)成份、药品容器各密封件应隔离贮存，直至经检验为止。合格后，方可发放。在符合211?80要求的地方中贮存。

§ 211.84 Testing and approval or rejection of

components, drug product containers, and

211?84成份、药品容器和密封件的试验、批准或拒收(a) Each lot of components, drug product containers,

and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.(a)每批成份、药品容器和密封件，在未经质量部门取样、检查合格前，不准使用。检验合格后发放使用。

(b) Representative samples of each shipment of each

lot shall be collected for testing or examination. The number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for component variability, confidence levels, and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where (b)每次到货的每个批号应收集代表性样品用于检测或检查。要取样的包装个数以及每个包装应取的样品量应根据适当标准来定，比如成份分可变程度的统计标准、供应商的信用级别、期望的精密度、供应商以往质量历史、以及按照法规§ 211.170规定的分析和保留的样品及其质量。

(c) Samples shall be collected in accordance with the

following procedures:(c)收集样品程序：

(1) The containers of components selected shall be

cleaned where necessary, by appropriate means.(1)必要时，用适当的方法，清洁选出成份容器；

(2) The containers shall be opened, sampled, and

resealed in a manner designed to prevent contamination of their contents and contamination of other components, drug product containers, or closures.(2)打开容器，取样，重新封口，防止其内容物受污染和其他成分、药品容器或密封件的污染。

(3) Sterile equipment and aseptic sampling techniques

shall be used when necessary.(3)必要时，使用灭菌设备和无菌取样技术。

(4) If it is necessary to sample a component from the top, middle, and bottom of its container, such sample subdivisions shall not be composited for testing.(4)如果需要从容器顶部、中部和底部的成分中取样，这些样品不得混合。

(5) Sample containers shall be identified so that the

following information can be determined: name of the material sampled, the lot number, the container from which the sample was taken, the date on which the sample was taken, and the name of the person who (5)标识样品容器，目的是确定如下资料：被取样的材料名称、批号、被取样的容器，取样日期及样品收集人的名字等。

(6) Containers from which samples have been taken

shall be marked to show that samples have been

removed from them.

(6)已取样的容器，应作标志，表示样品已取出。

(d) Samples shall be examined and tested as follows:(d)样品检验程序：

(1) At least one test shall be conducted to verify the identity of each component of a drug product. Specific identity tests, if they exist, shall be used.(1)一个药品的每个成分，最少做一个特性试验。如有专一特性实验就应采用。

(2) Each component shall be tested for conformity with all appropriate written specifications for purity, strength,

and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test l i i l (2)依照所有成文的规格标准检验每个成份的纯度、含量和质量。假如通过定期验证供应者的试验结果，证明供应商的分析结果正确可靠的基础上，可以接受以供应商提供的分析报告来代替上述试验，但最少要做个成份特性试验。

(3) Containers and closures shall be tested for conformance with all appropriate written procedures. In

lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals.(3)依照成文规程，检验容器和密封件。假如通过定期验证供应者的试验结果，证明供应商的分析结果正确可靠的基础上，可以接受以供应商提供的分析报告来代替上述试验，但最少做一次目检。

(4) When appropriate, components shall be

microscopically examined.(4)必要时，用显微镜检测成分。

(5) Each lot of a component, drug product container, or

closure that is liable to contamination with filth, insect infestation, or other extraneous adulterant shall be examined against established specifications for such (5)对于易受污物、昆虫或其他外来杂物污染的某一成份、药品容器或密封件，每批应按制订的标准检查，避免污染。

(6) Each lot of a component, drug product container, or closure that is liable to microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use.(6)对于易被微生物污染的某一成份、药品容器或密封件，而且对其预计的用途会产生不良影响，则每批在使用前应当做微生物试验。

(e) Any lot of components, drug product containers, or

closures that meets the appropriate written specifications of identity, strength, quality, and purity and related tests under paragraph (d) of this section may be approved and released for use. Any lot of such material that does not meet such specifications shall be （e）任何批号的成份、药品容器或密封件，若符合已成文的均一性、效价或含量、质量、纯度等的规格标准和本部分（d）的有关试验，可批准使用。任何批号的上述物料，不符合这些规格，应拒收。

§ 211.86 Use of approved components, drug

product containers, and closures.

211?86获准的成份、药品容器和密封件的使用Components,drug product containers,and closures

approved for use shall be rotated so that the oldest approved stock is used first.Deviation from this requirement is permitted if such deviation is temporary 获准使用的成份、药品容器和密封件，先入库者先用。若产生的偏差是暂时的和适当，这种偏差是容许的。

§ 211.87 Retesting of approved components, drug

product containers, and closures.

211?87获准的成份、药品容器和密封件的复检Components, drug product containers, and closures

shall be retested or reexamined, as appropriate, for

identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with §211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the component, drug product container, or closure.经质量控制部门批准或拒收的成份、药品容器、密封件，若长期贮存或曝露在空气、热或其他可能对其产生不良影响的环境后，应依照211?84，对均一性、效价或含量、质量、纯度等复检。

§ 211.89 Rejected components, drug product

containers, and closures.

211?89拒收的成份、药品容器和密封件Rejected components, drug product containers, and

closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.拒收的成份、药品容器和密封件应经鉴定和在隔离系统下加以控制，防止在生产和加工使用。

§ 211.94 Drug product containers and closures.211?94药品密封容器和密封件

(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.(a)药品包装容器和密封件应不起反应、不吸着、不吸附、不致改变药品的安全性、均一性、含量或效价、质量和纯度而超出制定的或其它颁布的规定要求。

(b) Container closure systems shall provide adequate

protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.(b)容器封口系统应对贮藏和使用过程中可预见的能引起药品变质或污染的外部因素提供足够的防护。

(c) Drug product containers and closures shall be clean

and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.(c)药品容器和密封件应清洁、灭菌和除热原，保证其适用于预期目的。

(d) Standards or specifications, methods of testing, and,

where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and (d)药品容器和密封件的标准或规格、检验方法（指清洁和消毒方法、除热原过程）应成文并遵循。

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

§ 211.100 Written procedures; deviations.211?100成文的规程、偏差(a) There shall be written procedures for production and

process control designed to assure that the drug

products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and (a)编写为保证药品的均一性、含量或效价、质量及纯度而设计的生产和加工控制程序，这些程序包括本部内全部要求。这些成文程序（包括变化）须经有关部门起草、审核和批准，然后再经质量控制部门审核与批准。

(b) Written production and process control procedures

shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and (b)在实施各种生产和加工控制功能中，遵循已制定的生产和加工控制程序，并在实施时以文件记录加以证明。程序中出现的任何偏差，应作记录，并提出证据。

§ 211.101 Charge-in of components.211?101成分的控制Written production and control procedures shall include

the following, which are designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to 成文的生产和控制程序包括下面的内容，其设计应保证所生产的药品具有的均一性、含量和效价、质量和纯度。

(a) The batch shall be formulated with the intent to provide not less than 100 percent of the labeled or established amount of active ingredient.(a)按处方配制的药品，保证其活性成份含量不低于100%标示量或规定量。

(b) Components for drug product manufacturing shall be

weighed, measured, or subdivided as appropriate. If a component is removed from the original container to another, the new container shall be identified with the following information:(b)生产药品用的成份应称量、测量或适当粉碎。若一种成份从原来容器转移到另一容器内，新容器上应有下列标识内容：

(1) Component name or item code;(1)成份名称或项目代码。

(2) Receiving or control number;(2)接收或控制号。

(3) Weight or measure in new container;(3)在新容器中的重量或份量。

(4) Batch for which component was dispensed, including its product name, strength, and lot number.(4)使用此成份配制的一批药品，包含其产品名称、规格和批号。

(c) Weighing, measuring, or subdividing operations for

components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that:(c)成份的称重、测量或粉碎操作，应受到严密的监督。盛放用于生产成份的每一容器，须经第二人检查，保证：

(1) The component was released by the quality control(1)此成份是由质量控制人员放行的。

(2) The weight or measure is correct as stated in the

batch production records;(2)重量或份量正确，与批生产记录一致。

(3) The containers are properly identified.(3)容器经严格区别。

(d) Each component shall be added to the batch by one

person and verified by a second person.（d）每一成份投料时，一人操作，另一人核对。§ 211.103 Calculation of yield.211?103 产量计算

Actual yields and percentages of theoretical yield shall

be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall be performed by one person and independently verified by 在药品生产、加工或贮存的每一适当阶段结束时，测算实际产量与理论产量的百分比。这个计算应由一人执行后，由另外一人独立进行核实。

§ 211.105 Equipment identification211?105设备鉴别(a) All compounding and storage containers, processing

lines, and major equipment used during the production of a batch of a drug product shall be properly identified at all times to indicate their contents and, when necessary, the phase of processing of the batch.(a)在整个生产周期内，同批药品生产使用的全部混合和贮存容器、生产线和主要设备应严格识别，标示出药品的成份，必要时，还应标出所处的加工阶段。

(b) Major equipment shall be identified by a distinctive identification number or code that shall be recorded in

the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code.(b)一种药品每批生产使用的主要设备，以一鉴别性识别号或代号加以识别。此鉴别号或代号记录在该批号产品的记录本。若生产中只使用一种特殊型号的设备，可用该设备名字代替鉴别性识别或代号。

§ 211.110 Sampling and testing of in-process

materials and drug products.

211?110中间体和药品的取样与检验(a) To assure batch uniformity and integrity of drug

products, written procedures shall be established and

followed that describe the in-process controls, and tests,

or examinations to be conducted on appropriate samples of in-process materials of each batch.Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures shall include, but are not limited to, the following, where

i t (a)制订和遵循说明每批的加工过程控制及对加工过程中材料的适当样品实行检验或检查的成文程序，保证药品的一致性和完整性。这些控制程序应当建立并用于监控产出和验证生产工艺的性能，考虑可能的引起产品和过程物料的性质变化的原因。上述控制程序包括，但不限于如下内容：

(1) Tablet or capsule weight variation;(1)片剂或胶囊的重量差异。

(2) Disintegration time;(2)崩解时间。

(3) Adequacy of mixing to assure uniformity and

homogeneity;(3)充分混和，保证均匀。

(4) Dissolution time and rate;(4)溶解时间和速率。

(5) Clarity, completeness, or pH of solutions.(5)溶液的澄明度、溶解完全性及PH值。

(b)Valid in-process specifications for such

characteristics shall be consistent with drug product

final specifications and shall be derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate.Examination and testing of samples shall assure that the drug product and in-process materials (b)考虑上述特性而制定的有效中间加工规格与药品最终规格一致。此中间加工规格应在以前可靠的加工方法稳定性评估和经应用统计学程序断定认为合适的基础上制定的。样品测试，保证药品和中间体符合规格标准。

(c) In-process materials shall be tested for identity,

strength, quality, and purity as appropriate, and approved or rejected by the quality control unit, during the production process, e.g., at commencement or completion of significant phases or after storage for long (c)过程物料应当根据适合程度检测鉴别、剂量、质量和纯度，并由质量部门在生产过程中，比如开始或完成重要步骤时或在长期储存以后，确定批准或拒绝使用。

(d) Rejected in-process materials shall be identified and

controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.(d)不合格的中间体，在隔离系统下标识及控制，防止其在生产或加工操作中使用。

§ 211.111 Time limitations on production.211?111生产时间限制When appropriate, time limits for the completion of each

phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.在适当时候，制定完成每一生产阶段的时间限制，保证药品质量。制定的时间限制产生偏差时，如这些偏差不损害药品质量，是可以接受的。这些偏差应有文字文件证明是正当的。

§ 211.113 Control of microbiological contamination.211?113微生物污染的控制

(a) Appropriate written procedures, designed to prevent

objectionable microorganisms in drug products not

required to be sterile, shall be established and followed.

(a)制订和遵循预防非无菌药品有害微生物的适当程序。

(b) Appropriate written procedures, designed to prevent

microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of any sterilization process.(b)制订和遵循预防无菌药品微生物污染的适当程序。这些程序应包括所有灭菌过程的验证。

§ 211.115 Reprocessing.211?115返工(a) Written procedures shall be established and

followed prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics.

(a)应建立并执行书面程序，有关不符合标准或质量标准的批的返工处理的系统，所采取的步骤以确保返工的批次符合所有已经建立的标准、质量标准和性质。

(b) Reprocessing shall not be performed without the

review and approval of the quality control unit.(b)没有质量控制部门审核与批准，不许进行返工。Subpart G-Packaging and Labeling Control G.包装和标签控制

§ 211.122 Materials examination and usage criteria.211?122材料的检查和使用标准

(a) There shall be written procedures describing in

sufficient detail the receipt, identification, storage,

handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be https://www.wendangku.net/doc/e21920578.html,beling and packaging materials shall be representatively sampled, and examined or tested upon receipt and before use in (a)制订详细标签和包装材料的接收、鉴别、贮存、搬运、取样、检验的程序，并遵循这些成文程序。在接收、用于药品包装和贴标签前，有代表性地对其取样与检查。

(b) Any labeling or packaging materials meeting

appropriate written specifications may be approved and released for use. Any labeling or packaging materials that do not meet such specifications shall be rejected to prevent their use in operations for which they are (b)只有符合成文规格标准的标签和包装材料，方可批准发放使用。不符合规格者，不得用于生产。

(c) Records shall be maintained for each shipment

received of each different labeling and packaging material indicating receipt, examination or testing, and whether accepted or rejected.(c)收到每次发货的每个不同的标签和包装材料应保留记录，记录应表明接收、检查或检测，以及是否接收或拒收。

(d) Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be stored separately with suitable identification. Access to the storage area shall be limited (d)用于不同药品、规格、剂型及成份数量的标签和包装材料应分别贮存，并挂上适当标识，只限经核准人员接近贮存地区。

(e) Obsolete and outdated labels, labeling, and other

packaging materials shall be destroyed.(e)作废和过时的标签、标示材料及其他包装材料应销毁。

(f) Use of gang printing of labeling for different drug

products or different strengths or net contents of the same drug product, is prohibited unless the labeling from gang-printed sheets is adequately differentiated by size, shape, or color.(f)不同产品或规格或净含量时使用联合印刷是禁止的，除非联合印刷页上的贴签得到足够的区别，比如大小、形状或颜色。

(g) If cut labeling is used, packaging and labeling operations shall include one of the following special (g)如果使用切割标签，在包装和标签时，至少有一项如下的专门的控制过程：

(1) Dedication of labeling and packaging lines to each

different strength of each different drug product.(1) 不同产品各个剂量应有专用贴签和包装线。

(2) Use of appropriate electronic or electromechanical

equipment to conduct a 100- percent examination for correct labeling during or after completion of finishing operations; or (2) 使用适当的电子的或电子机械的设备来100%的检查贴签过程或完成操作后的标签正确性。或

(3) Use of visual inspection to conduct a 100- percent

examination for correct labeling during or after completion of finishing operations for hand- applied labeling. Such examination shall be performed by one person and independently verified by a second person.(3) 使用目检来100%检查手工包装的贴签过程或完成操作后的标签正确性。这个检查应由一人执行，并有另外一人独立核实。

(h) Printing devices on, or associated with,

manufacturing lines used to imprint labeling upon the drug product unit label or case shall be monitored to assure that all imprinting conforms to the print specified in the batch production record.(h) 打印设备，或标签批号打印与产品生产线在一起或有联系时，应监控以确保所有的批号打印与产品批记录一致。

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41353, Aug.

3, 1993]

§ 211.125 Labeling issuance.211?125标签的发放

(a) Strict control shall be exercised over labeling issued

for use in drug product labeling operations.(a)严格控制用于药品的标签。

(b) Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production (b)已发放的一批标签材料，须认真检查其同一性，应与一批或单批生产记录中说明的标签一致。

(c) Procedures shall be utilized to reconcile the quantities of labeling issued, used, and returned, and

shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with § 211.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with §

211122()(2)(c)核对发放的，已使用的及退回的标签，若发现成品数量与发出的标签数量不符，差额超出根据先前历史水平定下的数量范围，则需对这些偏差作出评估，按照211?192要求调查原因。如果按照211.122(G)(2)执行的100%的贴签正确性检查，则切割或滚动贴签的平衡可以不做。

(d) All excess labeling bearing lot or control numbers

shall be destroyed.(d)印有批号或控制号的剩余标签，应全部销毁。

(e) Returned labeling shall be maintained and stored in

a manner to prevent mixups and provide proper(e)退回的标签，如保留应加上证明标志贮存，防止混淆。

(f) Procedures shall be written describing in sufficient

detail the control procedures employed for the issuance

of labeling; such written procedures shall be followed.

(f)制订发放标签的详细控制程序，并遵循执行。

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41345, Aug.

3, 1993]

§ 211.130 Packaging and labeling operations.211?130包装和贴签操作

There shall be written procedures designed to assure

that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate 设计保证标签、标示及包装材料正确用于药品的程序，并遵循。这些程序结合下列特征：

(a) Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products.(a)预防由物理的或其他操作空间物质引起的混淆和交叉污染

(b) Identification and handling of filled drug product

containers that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number (b)识别并处理已经装了药品的容器，放在一边，并且控制在未贴签的状态以便以后进行贴签操作，防止单个容器、批或部分批被误贴签。没有必要识别每个容器，但是要足够明确每个容器的名称、剂量、内容物的质量和批号或控制号。

(c) Identification of the drug product with a lot or control

number that permits determination of the history of the

manufacture and control of the batch.

(c) 用批号或控制号来识别，能确定批生产和控制历史

(d) Examination of packaging and labeling materials for

suitability and correctness before packaging operations, and documentation of such examination in the batch production record.( d)包装工作开展前，检查包装和标签材料的适用性和正确性，且这些检验所提供的证明文件应符合批生产记录。

(e) Inspection of the packaging and labeling facilities immediately before use to assure that all drug products

have been removed from previous operations. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records. (e)使用前立即检查包装和贴签设施，确保前次操作的药品已经被除去。也应检查并确保不能用来包装和贴签的物料已经被除去。检查结果应记录在产品批记录里面。

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41354, Aug.

3, 1993]

§ 211.132 Tamper-resistant packaging requirements

for over-the-counter (OTC) human drug products.

211?132人用非处方药（OTC）保险包装的要求(a) General. The Food and Drug Administration has the

authority under the Federal Food, Drug, and Cosmetic

Act (the act) to establish a uniform national requirement

for tamper-resistant packaging of OTC drug products that will improve the security of OTC drug packaging and help assure the safety and effectiveness of OTC drug products. An OTC drug product (except a dermatological, dentifrice, insulin, or throat lozenge product) for retail sale that is not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated under section 501 of the act or misbranded under section 502 of the act, or both.(a)一般来说，在联邦食品、药物和化妆品法规下，FDA有权制定非处方药保险包装的统一国家要求。提高非处方药包装的可靠性和有助保证非自主药的安全与效果。一种零售OTC 药品（除皮肤科药、洁牙剂、胰岛素、喉片除外）没有包装在保险包装内或没有适当的标签，根据联邦法规501部分，属掺假药；根据502部分或两者，此类属错贴标签。

(b) Requirement for tamper-resistant package. Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or

throat lozenge product) for retail sale shall package the product in a tamper-resistant package, if this product is accessible to the public while held for sale.A tamper-resistant package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design (e.g., an aerosol product container) or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). For purposes of this section, the term "distinctive by design'' means the packaging cannot be duplicated with commonly available materials or through commonly (b)每个OTC药品（皮肤科药、洁牙剂、胰岛素、喉片除外）生产者和包装者，应将零售OTC药品装入保险包装内，若此药易受公众影响，该药应在内保持至售出。保险包装是内有一个或多个指示物或障碍物的药品包装。若缺损或失落，能适当地给顾客提供已发生破损的明显证据。如果因缺损而使产品受损，则要求此包装在设计上应有特色（例如喷雾产品容器）或使用一个或多个有鉴别性指示物或障碍物加进包装内（例如图案、名称、注册商标、标识或图画等）。上述“在设计上有特色”之意，即此包装不能用一般的通用材料和加工工艺来复制。术语“喷雾产品”即用液化气体或压缩气体将成份从容器中喷出。保险包装可以是能提供目视其中包装完整性的密闭容器、第二容器、封闭系统或任何联合系统。这些保险装置被设计成在生产、分装和销售陈列期间，以适当方法搬运，保持不致受损坏。

(1) For two-piece, hard gelatin capsule products subject

to this requirement, a minimum of two tamper-resistant packaging features is required, unless the capsules are sealed by a tamper- resistant technology (1)两段式明胶硬胶囊产品，除非包装工艺密封的外，最少需二个保险装置。

(2) For all other products subject to this requirement,

including two-piece, hard gelatin capsules that are sealed by a tamper- resistant technology, a minimum of one tamper-resistant feature is required.(2)所有其他产品，包括经保险工艺密封的二段式明胶硬胶囊，最少需要一个保险装置。

(c) Labeling. Each retail package of an OTC drug product covered by this section, except ammonia inhalant in crushable glass ampules, aerosol products as defined in paragraph (b) of this section,or containers

of compressed medical oxygen, is required to bear a statement that is prominently placed so that consumers are alerted to the specific tamper-resistant feature of the package. The labeling statement is also required to be so placed that it will be unaffected if the tamper-resistant feature of the package is breached or missing. If the tamper-resistant feature chosen to meet the requirement in paragraph (b) of this section is one that uses an identifying characteristic, that characteristic is required to be referred to in the labeling statement.For example, the labeling statement on a bottle with a shrink band could say "For your protection, this bottle has an imprinted seal around the neck''(c)标签。除在易拆安瓿中氨吸入物、本部分的（b）节规定的喷雾产品或压缩医用氧容器外，本部分涉及的非处方药的每个零售包装，要求带有一“声明”放置在一明显的地方，使顾客对包装的特殊保险装置有所警觉。此标签“声明”不要求放置于适当的地方，当包装的保险装置破损或失落时，不受影响。如果选择符合本部分（b）节要求的保险装置是使用识别性质的话，那要参考标签“声明”。例如，在带有一收缩套的瓶上的标签“声明”应写“为了此瓶周围印有标志”。

(d) Request for exemptions from packaging and labeling requirements. A manufacturer or packer may

request an exemption from the packaging and labeling requirements of this section. A request for an exemption is required to be submitted in the form of a citizen petition under § 10.30 of this chapter and should be clearly identified on the envelope as a "Request for Exemption from Tamper-Resistant Rule.'' The petition is (d)申请免除对包装和标签的要求。生产者和馐者可申请免除本部分对包装和标签的要求。一个免除申请，要求按本章10?30，以公民申请形式提交，且根据“免除保险包装申请条例”加以鉴别。申请所需之内容如下：

(1) The name of the drug product or, if the petition seeks an exemption for a drug class, the name of the drug class, and a list of products within that class.(1)药品名称。若申请的是某一类药，需列出类别名称，并列出该类药中的产品表。

(2) The reasons that the drug product's compliance with the tamper-resistant packaging or labeling requirements of this section is unnecessary or cannot be achieved.(2)药品没必要实施或不能达到本部分的保险包装或标签的要求的理由。

(3) A description of alternative steps that are available,

or that the petitioner has already taken, to reduce the likelihood that the product or drug class will be the subject of malicious adulteration.(3)其他措施有描述，或当早已采取的措施有描述，以减少恶意掺假的可能性。

(4) Other information justifying an exemption.(4)证明免除是合理的其他资料。

(e)OTC drug products subject to approved new drug

applications.Holders of approved new drug

applications for OTC drug products are required under§

314.70of this chapter to provide the agency with notification of changes in packaging and labeling to comply with the requirements of this section.Changes in packaging and labeling required by this regulation may be made before FDA approval, as provided under §314.70(c)of this chapter.Manufacturing changes by which capsules are to be sealed require prior FDA l d § 31470(b) f thi h t (e)非处方药受已被批准的新药申请管辖。要求非处方药原被批准的新药申请持有人，根据本章314?70（c）提供的要求，可在FDA批准前实施。根据本章314?70（b），胶囊密封的生产改进需FDA先批准。

(f)Poison Prevention Packaging Act of1970.This section does not affect any requirements for"special packaging''as defined under§310.3(l)of this chapter and required under the Poison Prevention Packaging (f)1970年毒药预防包装条例。本部分不影响本章310?3（L）规定的特殊包装的任何要求和1970年毒药保护包装条例的要求

(Approved by the Office of Management and Budget under OMB control number 0910-0149)

[54 FR 5228, Feb. 2, 1989]（经管理和预算处批准，控制号0910149）[54联邦注册5228，1989年2月2日]。

§ 211.134 Drug product inspection.211?134药品检查

(a)Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct (a)在结束工作时，应检查已包装和贴标签的产品，保证本批容器和包装的标签正确无误。

(b)A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling.(b)操作结束时，每组收集一个代表性样品，同时检查标签。

(c)Results of these examinations shall be recorded in

the batch production or control records.(c)检查结果记录在该批的生产或控制记录中。§ 211.137 Expiration dating.211?137有效期

(a)To assure that a drug product meets applicable standards of identity,strength,quality,and purity at the time of use,it shall bear an expiration date determined by appropriate stability testing described in § 211.166.(a)保证一个产品在使用时符合均一性、效价或含量、质量和纯度等标准，应提供一个有效期。有效期按211?166所述的稳定性试验测定。

(b)Expiration dates shall be related to any storage conditions stated on the labeling,as determined by stability studies described in §211.166.(b)有效期是在符合标签上规定的贮存条件下，按211?166所述的稳定性试验测定。

(c)If the drug product is to be reconstituted at the time of dispensing,its labeling shall bear expiration information for both the reconstituted and (c)如药品在配制时要重新配伍，那重新配伍好的和未重新配伍的两种药品标签上均须提供有效日期。

(d)Expiration dates shall appear on labeling in

accordance with the requirements of§201.17of this(d)根据本章201?17的要求，有效日期应标在标签上。

(e)Homeopathic drug products shall be exempt from

the requirements of this section.(e)顺势治疗（homeopathic）药品免除本部分的要求。

(f)Allergenic extracts that are labeled"No U.S. Standard of Potency''are exempt from the requirements (f)标“没有美国效价标准”的变应原提取物免除本部分要求。

(g)New drug products for investigational use are exempt from the requirements of this section,provided

that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations.Where new drug products for investigational use are to be reconstituted at the time of dispensing,their labeling shall bear expiration information for the reconstituted drug product.(g)对于调查研究用新药，如果它们符合合适的标准或规格，并在临床研究使用能证明其稳定性，可以免除本部分要求。如研究用新药在配制时要重新配伍，那重新配伍好的药品标签上须标明有效日期。

(h)Pending consideration of a proposed exemption,

published in the Federal Register of September29, 1978,the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least3years as supported by appropriate stability (h)1978年9月29日联邦注册发表了一个未决的免除提议，本章的要求可以对人用OTC药品不执行，只要它们的标签不包括剂量限制而且在3年内稳定并有适当的稳定性数据来支持。

[43 FR 45077, Sept. 29, 1978, as amended at 46 FR 56412, Nov. 17, 1981; 60 FR 4091, Jan. 20, 1995][43联邦注册45077，1978年9月29日，修正，在46联邦56412，1981年11月17日，在60联邦4091，1995年1月20]。

Subpart H-Holding and Distribution H．贮存和销售

§ 211.142 Warehousing procedures.211?142入库程序

Written procedures describing the warehousing of drug

products shall be established and followed. They shall

include:

制订和遵循药品入库程序，包括：(a)Quarantine of drug products before release by the

quality control unit.(a)在质量控制部门放行前，药品待验。

(b)Storage of drug products under appropriate

conditions of temperature,humidity,and light so that the identity,strength,quality,and purity of the drug products are not affected.(b)药品在适当的温度、湿度和照明下贮存，不影响药品的均一性、效价或含量、质量及纯度。

§ 211.150 Distribution procedures.211?150销售程序

Written procedures shall be established, and followed,

describing the distribution of drug products. They shall

include:

制订和遵循药品销售程序，包括：(a) A procedure whereby the oldest approved stock of a

drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.(a)最早批准入库的药品，应先销售。若违背本要求的地方是暂时和适可的，这是允许的。

(b)A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.(b)通过每批药品的销售系统，能迅速追查药品，便于有必要召回。

Subpart I-Laboratory Controls I?实验室控制§ 211.160 General requirements.211?160总要求(a)The establishment of any specifications,standards,

sampling plans,test procedures,or other laboratory

control mechanisms required by this subpart,including

any change in such specifications,standards,sampling plans,test procedures,or other laboratory control mechanisms,shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.The requirements in this subpart shall be followed and shall be documented at the time of performance.Any deviation from the written specifications,standards,sampling plans,test procedures,or other laboratory control mechanisms h ll b d d d j tifi d (a)按本部分的要求，制订规格、标准、取样方法、试验程序或其他实验室控制机制，包括上述内容的修改，由有关部门起草，并经质量控制部门审核、批准。遵守本部分中各要求，在实施时，提供证明文件。任何超出成文的规格、标准、取样方法、试验程序或其他实验室控制机制的偏差，应作记录，并提供证明。

(b)Laboratory controls shall include the establishment

of scientifically sound and appropriate specifications, standards,sampling plans,and test procedures designed to assure that components,drug product containers,closures,in-process materials,labeling,and drug products conform to appropriate standards of identity,strength,quality,and https://www.wendangku.net/doc/e21920578.html,boratory controls (b)实验室控制内容，包括科学地制订完善、合理的规格、标准、取样方法及为保证各种成份、药品容器、密封件、中间体、标签和药品符合均一性、效价和含量、质量与纯度标准而设计的检验程序。实验室控制包括：

(1)Determination of conformance to appropriate written specifications for the acceptance of each lot within each

shipment of components,drug product containers, closures,and labeling used in the manufacture, processing,packing,or holding of drug products.The specifications shall include a description of the sampling and testing procedures used.Samples shall be representative and adequately identified.Such procedures shall also require appropriate retesting of any component,drug product container,or closure that i bj t t d t i ti (1)根据接收的规格，测定用于药品生产、加工包装及贮存的每装货量中的每批的成份、药品容器、密封件和标签。保证它们符合制定的规格标准。此规格包括使用的取样和检验程序说明。样品有代表性及经适当鉴别。这些程序亦要求对任何变质的成份、药品容器或密封件作重复检验。

(2)Determination of conformance to written

specifications and a description of sampling and testing procedures for in-process materials.Such samples shall be representative and properly identified.(2)根据中间体的成文规格和取样及检验程序，测定中间体。样品应有代表性和经适当鉴定。

(3)Determination of conformance to written descriptions

of sampling procedures and appropriate specifications for drug products.Such samples shall be representative and properly identified.(3)根据产品的成文规格和取样及检验程序，测定产品。样品应有代表性和经适当鉴定。

(4)The calibration of instruments,apparatus,gauges,

and recording devices at suitable intervals in accordance with an established written program containing specific directions,schedules,limits for accuracy and precision,and provisions for remedial action in the event accuracy and/or precision limits are not met.Instruments,apparatus,gauges,and recording devices not meeting established specifications shall not (4)设备、仪器、量具和记录设备的校验有适当的间隔，符合已经建立的书面程序，该程序包括详细的指导、时间表、准确度和精密度的限度、当准确度/精密度不符合限度时的校正措施。设备、仪器、量具和记录设备不符合已经建立的质量标准时不得使用。

§ 211.165 Testing and release for distribution.211?165销售前的检验与放行

(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory

conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on specific batches of shortlived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such testing is completed as soon as ibl (a)每批药品发放前须经实验室检测，保证其符合药品的最终规格标准，包括均一性和活性成份的含量。对有效期短的，需无菌和/或热原试验的放射药物特殊批号，可在无菌和/或热原试验完成前放行，但应规定尽快完成试验。

(b) There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.(b)根据需要，每批药品应进行适当的实验室有害微生物检验。

(c) Any sampling and testing plans shall be described

in written procedures that shall include the method of sampling and the number of units per batch to be tested; such written procedure shall be followed.(c)任何取样和检验方法，应在成文程序中说明。此程序包括取样方法和每批检验的取样数量，并遵循。

(d) Acceptance criteria for the sampling and testing

conducted by the quality control unit shall be adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or (d)对质量控制部门的取样和检验的接收标准是满足保证那些药品符合各自的规格标准和统计学的质量控制标准。这些标准是批准和发放药品的条件。此统计学质量控制标准包括适当的接收水平和/或适当的拒收水平。

(e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in (e)证实和提供文件证明经严格使用的检验方法的准确性、灵敏性、专属性和重现性。此验证和文件，可按照211?194（a）(2)项完成。

(f) Drug products failing to meet established standards

or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed. Prior to acceptance and use, reprocessed material must meet appropriate standards, specifications, and any other relevant criteria.(f)不符合制订的标准、规格和其他有关质量控制标准的药品，应拒收，但可返工。被返工的药品，在接收和应用前，须符合标准、规格和其他有关标准

§ 211.166 Stability testing.211?166稳定性试验 (a) There shall be a written testing program designed to

assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed (a)有一个设计确定药品稳定性的成文试验方案。此试验用于测定合适的贮存条件和有效期。该方案应包括：

(1) Sample size and test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability;(1)样品量和检测周期。是基于各自的检查特征的统计学标准而定，保障稳定性评价的正确性。

(2) Storage conditions for samples retained for testing;(2)保留样品的贮存条件。

(3) Reliable, meaningful, and specific test methods;(3)可靠的、有意义和有效的试验方法。

(4) Testing of the drug product in the same container-

closure system as that in which the drug product is

marketed;

(4)使用与上市销售药品相同的容器密闭系统。

(5) Testing of drug products for reconstitution at the time of dispensing (as directed in the labeling) as well as after they are reconstituted.(5)配制时，配伍的药品（按标签指出的）和配制后的药品的检验。

再别康桥中英文对照版

英文版 Saying Good-bye to Cambridge Again --by Xu Zhimo Very quietly I take my leave As quietly as I came here; Quietly I wave good-bye To the rosy clouds in the western sky. The golden willows by the riverside Are young brides in the setting sun; Their reflections on the shimmering waves Always linger in the depth of my heart. The floating heart growing in the sludge Sways leisurely under the water; In the gentle waves of Cambridge I would be a water plant! That pool under the shade of elm trees Holds not water but the rainbow from the sky; Shattered to pieces among the duckweeds Is the sediment of a rainbow-like dream? To seek a dream? Just to pole a boat upstream To where the green grass is more verdant; Or to have the boat fully loaded with starlight And sing aloud in the splendor of starlight. But I cannot sing aloud Quietness is my farewell music; Even summer insects heap silence for me Silent is Cambridge tonight! Very quietly I take my leave As quietly as I came here; Gently I flick my sleeves Not even a wisp of cloud will I bring away 中文版 再别康桥 ----徐志摩 轻轻的我走了， 正如我轻轻的来； 我轻轻的招手， 作别西天的云彩。 那河畔的金柳，

香港地名中英文对照表

香港地名中英文对照表香港分为十八个行政分区，每行政区设一个区议会，负责讨论区内民生事务。18个分区分别为： 香港岛(Hong Kong Island)(共有4个分区) 中西区(Central and Western District) 东区(Eastern District) 南区(Southern District) 湾仔区(Wan Chai District) 九龙(Kowloon)(共有5个分区) 九龙城区(Kowloon City District) 观塘区(Kwun Tong District) 深水埗区(Sham Shui Po District) 黄大仙区(Wong Tai Sin District) 油尖旺区(Yau Tsim Mong District) 新界(New Territories)(共有9个分区) 离岛区(Island District) 葵青区(Kwai Tsing District) 北区(North District) 西贡区(Sai Kung District) 沙田区(Sha Tin District) 大埔区(Tai Po District) 荃湾区(Tsuen Wan District) 屯门区(Tuen Mun District) 元朗区(Yuen Long District)

香港地名中英文对译 九龍水塘九龍城區九龍塘九龍灣 Kowloon Reservoir Kowloon City Kowloon Tong Kowloon Bay 八仙嶺上水上環土瓜灣 Pat Sin Leng Sheung Shui Sheung Wan To Kwa Wan 大水坑大老山大坑大尾篤 Tai Shui Hang Tate''s Cairn Tai Hang Tai Mei Tuk 大角咀大東山大埔區大埔滘 Tai Kok Tsui Tai Tung Shan Tai Po Tai Po Kau 大埔墟大浪灣大圍大帽山 Tai Po Market Tai Long Wan Tai Wai Tai Mo Shan 大窩口大網仔大潭水塘大潭灣 Tai Wo Hau Tai Mong Tsai Tai Tam Reservoirs Tai Tam Bay 大澳大嶼山大鵬灣大欖涌 Tai O Lantau Island Tai Pang Wan Tai Lam Chung 大欖涌水塘小西灣小欖中西區 Tai Lam Chung Siu Sai Wan Siu Lam Central and Western Reservoir 中環井欄樹元朗區分流 Central Tseng Lan Shue Yuen Long Fan Lau 天水圍天后太子太古 Tin Shui Wai Tin Hau Prince Edward Tai Koo 太和屯門區火炭牛池灣 Tai Wo Tuen Mun Fo Tan Ngau Chi Wan 牛尾海牛頭角北角北區 Ngau Mei Hoi Ngau Tau Kok North Point North 北潭涌打鼓嶺汀九石門 Pak Tam Chung Ta Kwu Ling Ting Kau Shek Mun 石崗石硤尾石塘咀石壁

一些香港地名中英对照

一些香港地名中英对照 2008年12月26日10:30 标签：暂无 觉得香港的地名很陌生，为工作方便，收集一些中英文对照。 香港分为十八个行政分区，每行政区设一个区议会，负责讨论区内民生事务。18个分区分别为：香港岛(Hong Kong Island)(共有4个分区) 中西区(Central and Western District) 东区(Eastern District) 南区(Southern District) 湾仔区(Wan Chai District) 九龙(Kowloon)(共有5个分区) 九龙城区(Kowloon City District) 观塘区(Kwun Tong District) 深水埗区(Sham Shui Po District) 黄大仙区(Wong Tai Sin District) 油尖旺区(Yau Tsim Mong District) 新界(New Territories)(共有9个分区) 离岛区(Island District) 葵青区(Kwai Tsing District) 北区(North District) 西贡区(Sai Kung District) 沙田区(Sha Tin District) 大埔区(Tai Po District) 荃湾区(Tsuen Wan District)

屯门区(Tuen Mun District) 元朗区(Yuen Long District) Chan Uk 陈屋 Chau Tau 洲头 Cheung Sha Wan 长沙湾Ching Chau Steep Island Green Island Tsing Chau Table Island 青洲 Chuk Hang 竹坑 Chuk Yuen 竹园 Chung Hau 涌口 Chung Uk Tsuen 钟屋村Ham Tin 咸田 Hung Fa Leng Robin's Nest 红花岭 Kai Kung Leng 鸡公岭Kai Kung Shan 鸡公山Kwun Yam Shan 观音山Lai Chi Yuen 荔枝园 Lei Uk 李屋 Lin Fa Shan 莲花山 Lo Uk 罗屋 Luk Wu 鹿湖 Lung Mei 龙尾 Nam Fung Wan 南风湾Nam Hang 南坑 Nam Shan 南山 Nam Wan 南湾 Ng Uk Tsuen 吴屋村Nga Yiu Tau 瓦头 Ngan Chau Flat Island Round Island 银洲 Ngau Liu 牛寮 Pak Kok North Point Boulde Point

《再别康桥》-中英文对照

《再别康桥》英文翻译 Saying Good-bye to Cambridge Again 徐志摩by Xu Zhimo 轻轻的我走了，Very quietly I take my leave 正如我轻轻的来；As quietly as I came here; 我轻轻的招手，Quietly I wave good-bye 作别西天的云彩。To the rosy clouds in the western sky. 那河畔的金柳The golden willows by the riverside 是夕阳中的新娘Are young brides in the setting sun 波光里的艳影，Their reflections on the shimmering waves 在我的心头荡漾。Always linger in the depth of my heart. 软泥上的青荇，The floatingheart growing in the sludge 油油的在水底招摇；Sways leisurely under the water; 在康河的柔波里，In the gentle waves of Cambridge 我甘心做一条水草I would be a water plant! 那榆荫下的一潭，That pool under the shade of elm trees 不是清泉，是天上虹Holds not water but the rainbow from the sky; 揉碎在浮藻间，Shattered to pieces among the duckweeds 沉淀着彩虹似的梦。Is the sediment of a rainbow-like dream? 寻梦？撑一支长篙，To seek a dream? Just to pole a boat upstream 向青草更青处漫溯，To where the green grass is more verdant; 满载一船星辉，Or to have the boat fully loaded with starlight 在星辉斑斓里放歌And sing aloud in the splendour of starlight.

日本地名总汇

日本地名总汇 东京（とうきょう）是日本的政治、经济、文化中心，是日本的海陆空交通的枢纽，是现代化国际都市和世界著名旅游城市之一。 新宿（しんじゅく）：日本东京的一个地区名，指的是以新宿车站为中心的地区，隶属东京都新宿区管辖。与涩谷、池袋并列为东京都的3大副都心之一。 池袋（いけぶくろ）：是中国留学生的主要聚集地，因为物价比较便宜。 浅草（あさくさ）：是庶民的居住地，在大街上穿西服会很不搭调，因为这里大家都穿拖鞋上街。 秋葉原（あきはばら）：是世界上屈指可数的电器一条街。时代尖端的电脑、手机、网络相关、家电都可以在秋叶原找到。 大阪（おおさか）：大阪市位于日本本州西部，座落近畿平原，面临大阪湾。古时为京都的外港。与京都、神户合称为京阪神。是西日本、近畿地方、京阪神都市圈及大阪都市圈的行政、产业、文化、交通中心，也是大阪府府厅所在地。白天人口仅次于东京23区为全国第二名，夜间人口次于横滨市为全国第三名。

神田（かんだ）：停驻于"观稼台"上，远处那层层梯田状的钟乳凝石就是举世闻名的神田。【神田祭（かんだまつり）：神田祭围绕神田明神神社举行，距离著名的秋叶原电器街不远。神田祭始于17世纪初期，是为了庆祝德川家康在关原之战役中的胜利，这一战役是日本历史上的转折点，为日本带来了长达250年的和平时期。神田神社供奉的三位神灵当中，两位是神话传说中在新年降临到日本的七福神中的两位，而另一位是平将门，在10世纪敢于公然反叛天皇朝廷自立皇号的唯一一位日本武士。与三社祭一样，神田祭也是每年举行一次，但是在阳历奇数年的5月】 渋谷（しぶや）：涉谷，日本东京都涉谷区中部、涉谷车站附近一地区。因涉谷车站是个枢纽站，上下乘客较多，故附近已形成繁华街区。 仙台（せんだい）：仙台是日本本州东北地区最大城市，经济和文化中心，宫城县首府。面积237平方公里，人口 68.9万(1986)。而地势东南部低平，西、北部为丘陵。气候温凉湿润，年平均气温12℃，1月－3.2℃， 8月28.2℃。1889年设市。 大手町（おおてまち）：是日本城郭之附近常见的地名。特别是江户城附近位置，即东京之大手町，与邻接的丸之内同为日本经济之中心地。 日本橋（にほんばし）：（花岗岩制，1911年4月3日建成）日本桥（にほんばし）是日本东京中央区，中央通横跨日本桥川的一条桥，亦成为邻近地带的地名。日本桥是东京都的道路元标，即日本道路网的起点。 六本木(ろっぽんぎ)是日本东京港区其中一个区域，以夜生活及西方人聚集而闻名。六本木位处赤坂以南，麻布以北。 神保町（じんぼうちょう）：是东京千代田区的一个町。这条街道上有很多书店和出版社，是世界上最大的旧书店街。 長崎（ながさき）：长崎的地形宛如一个圆形剧场，将长崎港广阔无垠的海面展现在舞台上。这里的山村农舍一直排列到山顶，形成一道亮丽的风景线，也是长崎的一大特色。号称价值“1000万美金”的长崎夜景实际上大多是农家灯火交织而成的迷人景象。以长崎港为中心，长崎市开展着与众多国家的交流往来，孕育了长崎独有的节日、饮食文化和传统。 宮崎（みやざき）：被称为“向阳国”。这里气候温暖，日照时间长，雨量充沛，因此自然环境十分优越，人们生活富足充裕。被外县人称为“居住条件优越的县”。位于九州地方的东南部，首府宫崎市。 広島（ひろしま）：广岛市是日本广岛县的县厅所在地，自毛利氏入府以来就是日本中国地方的最大城市。广岛市是世界上第一个被核武器原子弹轰炸的城市。

《再别康桥》英汉版本及诗歌赏析

《再别康桥》英汉语版本及诗歌赏析Saying Good-bye to Cambridge Again By Xu Zhimo 再别康桥 徐志摩 Very quietly I take my leave As quietly as I came here Quietly I wave good-bye To the rosy clouds in the western sky 轻轻的我走了 正如我轻轻的来 我轻轻的招手 作别西天的云彩 The golden willows by the riverside Are young brides in the setting sun Their reflections on the shimmering waves Always linger in the depth of my heart 那河畔的金柳 是夕阳中的新娘 波光里的艳影 在我的心头荡漾 The floating heart growing in the sludge Sways leisurely under the water In the gentle waves of Cambridge I would be a water plant 软泥上的青荇 油油的在水底招摇 在康桥的柔波里 我甘心做一条水草 That pool under the shade of elm trees Holds not water but the rainbow from the sky Shattered to pieces among the duckweeds Is the sediment of a rainbow-like dream 那榆荫下的一潭 不是清泉,是天上虹 揉碎在浮藻间 沉淀着彩虹似的梦 To seek a dream? Just to pole a boat upstream To where the green grass is more verdant Or to have the boat fully loaded with starlight And sing aloud in the splendour of starlight 寻梦？撑一支长蒿 向青草更青处漫溯 满载一船星辉 在星辉斑斓里放歌

再别康桥英文版

Saying Good-bye to Cambridge Again --by Xu Zhimo 再别康桥徐志摩 Very quietly I take my leave As quietly as I came here; Quietly I wave good-bye To the rosy clouds in the western sky. The golde n willows by the riverside Are young brides in the sett ing sun; Their reflecti ons on the shimmeri ng waves Always lin ger in the depth of my heart. The floati ng heart grow ing in the sludge Sways leisurely un der the water; In the gen tle waves of Cambridge I would be a water pla nt! That pool un der the shade of elm trees Holds not water but the rain bow from the sky; Shattered to pieces among the duckweeds Is the sedime nt of a rai nbow-like dream? To seek a dream? Just to pole a boat upstream To where the gree n grass is more verda nt; Or to have the boat fully loaded with starlight And si ng aloud in the sple ndor of starlight.

日本所有地名的英文

日本所有地名的英文(法文同) 东京地区 东京TOKYO 六本木ROPPONGI 新宿SHINJUKU 原宿HARAJUKU 银座GINZA 涩谷SHIBUYA 上野UNEO 池袋IKEBUKURO 浅草ASAKUSA 赤阪AKASAKA 东京附近 日光nikko 热川atagawa 镰仓kamakura 河津kawazu 那须nasu 河津七泷kawazu nanadaru 江之岛enoshima 下田shimoda 热海atami 下贺茂shimogamo 伊东ito 三岛mishima 小室山komuroyama 韭山nirayama 川奈kawana 伊豆长冈izu nagaoka 伊豆高原izu kogen 箱根hakone 一碧湖ippeki 富士山fujiyama 东北地区 青森aomori 松岛matsushima 八甲田山hakkoda-san 牡鹿半岛oshika-hanto 十和田湖towada-ko 山寺yamadear 弘前hirosaki 最上峡mogami-kyo 角馆kakunodate 酒田sakata 田泽湖tazawa-ko 鹤冈tsuruoka 盛冈morika 出羽三山dewa sanzan 八幡平hachimantai 会津若松aizu wakamatsu 平泉hiraizumi 猪苗代inawashiro 仙台sendai 磐梯山bandai-san 秋保温泉akiu onsen 磐梯高原bandai kogen 作并温泉sakunami onsen 喜多方kitakata 本州中部 名古屋nagoya 上高地kamikochi 犬山inuyama 乘鞍高原norikura kogen 明治村meiji-mura 信浓大町shinano omachi 高山takayama 立山黑部tateyama kurobe 古川furukawa 仁科三湖nishina-sanko 长野nagano 白马八方hakuba

再别康桥英文翻译

再别康桥英文翻译 Saying Good-bye to Cambridge Again 徐志摩by Xu Zhimo 轻轻的我走了，Very quietly I take my leave 正如我轻轻的来；As quietly as I came here; 我轻轻的招手，Quietly I wave good-bye 作别西天的云彩。To the rosy clouds in the western sky. 那河畔的金柳The golden willows by the riverside 是夕阳中的新娘Are young brides in the setting sun 波光里的艳影，Their reflections on the shimmering waves 在我的心头荡漾。Always linger in the depth of my heart. 软泥上的青荇，The floatingheart growing in the sludge 油油的在水底招摇；Sways leisurely under the water; 在康河的柔波里，In the gentle waves of Cambridge 我甘心做一条水草I would be a water plant! 那榆荫下的一潭，That pool under the shade of elm trees 不是清泉，是天上虹Holds not water but the rainbow from the sky; 揉碎在浮藻间，Shattered to pieces among the duckweeds 沉淀着彩虹似的梦。Is the sediment of a rainbow-like dream? 寻梦？撑一支长篙，To seek a dream? Just to pole a boat upstream 向青草更青处漫溯，To where the green grass is more verdant; 满载一船星辉，Or to have the boat fully loaded with starlight

柬埔寨地名中英文对照 Cambodia

柬埔寨Cambodia 金边Phnom Penh 暹粒Siem Reap 南门外 1. 吴哥窟（小吴哥）Angkor Wat 2. 南门South Gate 3. 巴肯山Bakeng 4. 巴色占空寺Baksei Chamkrong 吴哥城（大吴哥）Angkor city 5. 巴戎寺Bayon 6. 八方寺Baphuon 7. 战象台Terrace of the Elephant 8. 癞王台Terrace of the Leper King

9. 空中宫殿Phimeanakas 10. 圣琵丽寺Preah Palilay 11. 泰普拉南佛寺Tep Pranam 12. 圣皮度寺Preah Pithu 13. 北克朗（北大仓）North Kleang 14. 南克朗（南大仓）South Kleang 15. 十二塔Prasat Sour Prats 东门外 16. 东门（胜利门）Victory gate 17. 周萨神庙Chau Say Thevoda 18. 托马农神庙Thommanom 19. 石桥Spean Thma 20. 医院Chapel of the hospital 21. 茶胶寺Ta Keo

22. 比粒寺Pre Rup 东圈 23. 塔布笼寺Ta Prohm 24. 巴琼寺(Prasat) Bat Chum 25. 班提可待Banteay Kdei 26. 班提普瑞Banteay Prei 27. 克柔口Krol Ko 28. 皇家浴池Sras Srang 29. 豆蔻寺(Prasat) Kravan 30. 东梅奔寺East Mebon 31. 圣剑寺Preah Khan 32. 龙蟠水池Neak Pean 33. 塔逊Ta Som

日本地名英文对照

Hokkaido Region 北海道地区 1. Hokkaido 北海道 Tohoku Region 东北地区 2. Aomori 青森 3. Akita 秋田 4. Iwate 岩手 5. Yamagata 山形 6. Miyagi 宫城 7. Fukushima 福岛 Kanto Region 关东地区 8. Tochigi 栃木9. Gunma 群马10. Ibaragi 茨城 11. Saitama 埼玉12. Chiba 千叶13. Tokyo 东京14. Kanagawa 神奈川 Chubu Region 中部地区 15. Yamanashi 山梨16. Shizuoka 静冈17. Niigata 新泻 18. Nagano 长野19. Toyama 富山20. Ishikawa 石川 21. Fukui 福井22. Gifu 岐阜23. Aichi 爱知 Kinki Region 近畿地区 24. Shiga 滋贺25. Kyoto 京都26. Mie 三重27. Nara 奈良 28. Wakayama 和歌山29. Osaka 大阪30. Hyogo 兵库

Chugoku Region 中国地区 31. Tottori 鸟取32. Okayama 冈山33. Hiroshima 广岛县 34. Shimane 岛根35. Yamaguchi 山口 Shikoku Region 四国地区 36. Kagawa 香川37. Tokushima 徳岛38. Ehime 爱媛39. Kochi 高知 Kyushu Region 九州地区 40. Fukuoka 福冈41. Saga 佐贺42. Nagasaki 长崎 43. Oita 大分44. Miyazaki 宮崎45. Kumamoto 熊本 46. Kagoshima 鹿儿岛47. Okinawa 冲绳 另：本次在报道中经常被提到的地方： Sendai 仙台宫城县首府 HONSHU 本州日本是由北海道、本州、四国和九州四个大岛和多个小岛组成的。

《再别康桥》英文版

《再别康桥》英文版各位读友大家好！你有你的木棉，我有我的文章，为了你的木棉，应读我的文章！若为比翼双飞鸟，定是人间有情人！若读此篇优秀文，必成天上比翼鸟！ 篇一：《再别康桥》英文版Saying Good-bye to Cambridge Again Very quietly I take my leave As quietly as I came here; Quietly I wave good-bye To the rosy clouds in the western sky.The golden willows by the riversideAre young brides in the setting sun; Their reflections on the shimmering wavesAlways linger in the depth of my heart.The floating heart growing in the sludgeSways leisurely under the water; In the gentle waves of CambridgeI would be a water plant! That pool under the shade of elm trees Holds not water but the rainbow from the sky;Shattered to pieces among the duckweedsIs the sediment of a rainbow-like dream? To seek a dream? Just

《再别康桥》英文原文

《再别康桥》英文原文 Saying Good-bye to Cambridge Again --- by Xu Zhimo Very quietly I take my leave As quietly as I came here; Quietly I wave good-bye To the rosy clouds in the western sky。 The golden willows by the riverside Are young brides in the setting sun; Their reflections on the shimmering waves Always linger in the depth of my heart。 The floatingheart growing in the sludge Sways leisurely under the water; In the gentle waves of Cambridge I would be a water plant! That pool under the shade of elm trees Holds not water but the rainbow from the sky; Shattered to pieces among the duckweeds Is the sediment of a rainbow-like dream? To seek a dream?Just to pole a boat upstream To where the green grass is more verdant; Or to have the boat fully loaded with starlight And sing aloud in the splendour of starlight。 But I cannot sing aloud Quietness is my farewell music;

日本英文地名

1东京地区 东京TOKYO 六本木ROPPONGI 新宿SHINJUKU 原宿HARAJUKU 银座GINZA 涩谷SHIBUYA 上野UNEO 池袋IKEBUKURO 浅草ASAKUSA 赤阪AKASAKA 2东京附近 日光nikko 热川atagawa 镰仓kamakura 河津kawazu 那须nasu 河津七泷kawazu nanadaru 江之岛enoshima 下田shimoda 热海atami 下贺茂shimogamo 伊东ito 三岛mishima 小室山komuroyama 韭山nirayama 川奈kawana 伊豆长冈izu nagaoka 伊豆高原izu kogen 箱根hakone 一碧湖ippeki 富士山fujiyama 3东北地区 青森aomori 松岛matsushima 八甲田山hakkoda-san 牡鹿半岛oshika-hanto 十和田湖towada-ko 山寺yamadear 弘前hirosaki 最上峡mogami-kyo 角馆kakunodate 酒田sakata 田泽湖tazawa-ko 鹤冈tsuruoka 盛冈morika 出羽三山dewa sanzan 八幡平hachimantai 会津若松aizu wakamatsu 平泉hiraizumi 猪苗代inawashiro 仙台sendai 磐梯山bandai-san 秋保温泉akiu onsen 磐梯高原bandai kogen 作并温泉sakunami onsen 喜多方kitakata 4本州中部 名古屋nagoya 上高地kamikochi 犬山inuyama 乘鞍高原norikura kogen 明治村meiji-mura 信浓大町shinano omachi 高山takayama 立山黑部tateyama kurobe 古川furukawa 仁科三湖nishina-sanko 长野nagano 白马八方hakuba 户隐togakushi 冈谷ogaya 草津kusatsu 白桦湖shirakaba

再别康桥中英版

再别康桥中英版 Company Document number：WTUT-WT88Y-W8BBGB-BWYTT-19998

再别康桥(Saying Good-bye to Cambridge Again) 徐志摩 Very quietly I take my leave 轻轻的我走了 As quietly as I came here; 正如我轻轻的来Quietly I wave good-bye 我轻轻的招手 To the rosy [rzi] clouds in the western sky. 作别西天的云彩The golden willows by the riverside 那河畔的金柳 Are young brides in the setting sun; 是夕阳中的新娘Their reflections on the shimmering waves 波光里的艳影Always linger in the depth of my heart. 在我的心头荡漾The floating heart growing in the sludge 软泥上的青荇Sways leisurely under the water; 油油的在水底招摇 In the gentle waves of Cambridge 在康河的柔波里 I would be a water plant! 我甘心做一条水草？That pool under the shade of elm trees 那榆荫下的一潭Holds not water but the rainbow from the sky; 不是清泉，是天上虹 Shattered to pieces among the duck weeds 揉碎在浮藻间 Is the sediment of a rainbow-like dream 沉淀着彩虹似的梦To seek a dream 寻梦

柬埔寨地名中英文对照 Cambodia

柬埔寨Cambodia 金边Phnom Penh 暹粒Siem Reap 南门外 1.吴哥窟（小吴哥）Angkor Wat 2.南门South Gate 3.巴肯山Bakeng 4.巴色占空寺Baksei Chamkrong 吴哥城（大吴哥）Angkor city 5.巴戎寺Bayon 6.八方寺Baphuon 7.战象台Terrace of the Elephant 8.癞王台Terrace of the Leper King 9.空中宫殿Phimeanakas 10.圣琵丽寺Preah Palilay 11.泰普拉南佛寺Tep Pranam 12.圣皮度寺Preah Pithu 13.北克朗（北大仓）North Kleang 14.南克朗（南大仓）South Kleang 15.十二塔Prasat Sour Prats 东门外

16.东门（胜利门）Victory gate 17.周萨神庙Chau Say Thevoda 18.托马农神庙Thommanom 19.石桥Spean Thma 20.医院Chapel of the hospital 21.茶胶寺Ta Keo 22.比粒寺Pre Rup 东圈 23.塔布笼寺Ta Prohm 24.巴琼寺(Prasat) Bat Chum 25.班提可待Banteay Kdei 26.班提普瑞Banteay Prei 27.克柔口Krol Ko 28.皇家浴池Sras Srang 29.豆蔻寺(Prasat) Kravan 30.东梅奔寺East Mebon 31.圣剑寺Preah Khan 32.龙蟠水池Neak Pean 33.塔逊Ta Som 外圈 34.崩密裂Beng Mealea

再别康桥中英文对照

小学生英文朗诵诗歌原稿 New Year's Beginning The biggest night of the year To say goodbye to the past And bring in the new with cheer Surrounded by family and Friends so dear- Memories are made to last Throughout our forthcoming years At the birth of each New Year God lights a candle for us all To give guidance in our lives To see his children free from fall As the wonder of time Finally strikes twelve We celebrate together New Year's first hour The Flight of Youth 青春的飞逝 There are gains for all our losses. 我们失去的一切都能得到补偿，There are balms for all our pain; 我们所有的痛苦都能得到安慰；But when youth,the dream,departs 可是梦境似的青春一旦消逝， It takes something from our hearts, 它带走了我们心中的某种美好，And it never comes again. 从此一去不复返。 We are stronger, and are better, 我们变得日益刚强、更臻完美，Under ma nhood’s sterner reign; 在严峻的成年生活驱使下； Still we feel that something sweet 可是依然感到甜美的情感，

世界各国的国名和地名(英汉对照)

1. 欧洲国家列表 国家名称翻译世界各国首都列表各国首都名称翻译安道尔Andorra 安道尔Andorra 奥地利Austria 维也纳Vienna 阿尔巴尼亚Albania 地拉那Tirana 爱尔兰Ireland 都柏林Dublin 爱沙尼亚Estonia 塔林Tallinn 冰岛Iceland 雷克雅未克Reykjavik 白俄罗斯Belarus 明斯克Minsk 保加利亚Bulgaria 索非亚Sofia 波兰Poland 华沙Warsaw 波斯尼亚和黑塞哥维那Bosnia 萨拉热窝Sarajevo 比利时Belgium 布鲁塞尔Brussels 德国Germany 柏林Berlin 丹麦Denmark 哥本哈根Copenhagen 俄罗斯联邦Russia 莫斯科Moscow 法国France 巴黎Paris 芬兰Finland 赫尔辛基Helsinki 荷兰Holland 阿姆斯特丹Amsterdam 捷克Czech 布拉格Prague 克罗地亚Croatia 萨格勒布Zagreb 拉脱维亚Latvia 里加Riga 立陶宛Lithuania 维尔纽斯Vilnius 列支敦士登Liechtenstein 瓦杜兹Vaduz 罗马尼亚Romania 布加勒斯特Bucharest 马其顿Macedonia 斯科普里Skopje 马耳他Malta 瓦莱塔 卢森堡Luxembourg 卢森堡Luxembourg 摩纳哥Monaco 摩纳哥Monaco 摩尔多瓦Moldova 基希讷乌Chisinau 挪威Norway 奥斯路Oslo 塞尔维亚和黑山共和国Serbia and Montenegro 葡萄牙Portugal 里斯本Lisbon 瑞典Sweden 斯德哥尔摩Stockholm 瑞士Switzerland 伯尔尼Bern 斯洛伐克Slovak 布拉提斯拉发Bratislava 斯洛文尼亚Slovenia 卢布尔雅那Ljubljana 圣马力诺San Marino 圣马力诺San Mari no 乌克兰Ukraine 基辅Kiev 西班牙Spain 马德里Madrid 希腊Greece 雅典Athens 匈牙利Hungary 布达佩斯Budapest 意大利Italy 罗马Rome

英文诗五篇--中英文对照(再别康桥等)

英文诗五篇—中英文对照 美文欣赏之一--再别康桥 徐志摩 Saying Good-bye to Cambridge Again 轻轻的我走了， Very quietly I take my leave 正如我轻轻的来； As quietly as I came here; 我轻轻的招手， Quietly I wave good-bye 作别西天的云彩。 To the rosy clouds in the western sky. 那河畔的金柳， The golden willows by the riverside 是夕阳中的新娘。 Are young brides in the setting sun; 波光里的艳影， Their reflections on the shimmering waves 在我的心头荡漾。 Always linger in the depth of my heart. 软泥上的青荇， The floating heart growing in the sludge 油油的在水底招摇； Sways leisurely under the water; 在康河的柔波里， In the gentle waves of Cambridge 我甘心做一条水草！ I would be a water plant! 那榆阴下的一潭， That pool under the shade of elm trees 不是清泉，是天上虹 Holds not water but the rainbow from the sky; 揉碎在浮藻间， Shattered to pieces among the duckweeds 沉淀着彩虹似的梦 Is the sediment of a rainbow-like dream?

越南地名中英文对照表

河内Hanoi 胡志明市Thanh Pho Ho Chi Minh / Ho Chi Minh City 海防Hai Phong / Haiphong 越南地名中英文对照表 安江An Giang 龙川Long Xuyen 巴地-头顿Ba Ria-Vung Tau 头顿Vung Tau 北太Bac Thai 太原Thai Nguyen 槟知Ben Tre 槟知Ben Tre 平定Binh Dinh 归仁Quy Nhon 平顺Binh Thuan 藩切Phan Thiet 芹苴Cao Tho 芹苴Can Tho 高平Cao Bang 高平Cao Bang 多乐Dac lac 邦美蜀Buon Me Thuot 同奈Dong Nai 边和Bien Hoa 同塔Dong Thap 高岭Cao Lamh 嘉莱Gia Lai 波来古Play Ku 河北Ha Bac 北江Bac Giang 河江Ha Giang 河江Hai Duang 海兴Hai Hung 海阳Hai Duang 河西Ha Tay 河东Ha Dong 河静Ha Tinh 河静Ha Tinh 和平Hoa Binh 和平Hoa Binh

庆和Khanh Hoa 芽庄Nha Trang 昆嵩Kon Tum 昆嵩Kon Tum 建江Kien Giang 迪石Rach Gia 莱州Lai Chau 莱州Lai Chua 林同Lam Dong 大叻Da Lat 谅山Lang Son 谅山Lang Son 老街Lao Cai 老街Lao Cai 隆安Long An 新安Tan An 明海Minh Hai 金瓯Ca Mau 南河Nam Ha 南定Nam Dinh 义安Nghe An 荣市Vinh 宁平Ninh Binh 宁平Ninh Binh 宁顺Ninh Thuan 藩朗-塔占Phan Rang-Thap Cham 富安Phu Yen 绥和Tuy Hoa 广平Quang Binh 洞海Dong Hoi 广南-岘港Quang Nam-Da Nang 岘港Da Nang 广义Quang Ngai 广义Quang Ngai 广宁Quang Ninh 鸿基Hon Gai 广治Quang Tri 东河Dong Ha 朔庄Soc Trang 朔庄Soc Trang 小河Song Be 土龙木Thu Dau Mot