21CFR Part 210&211 中英文对照版_2020.4

PART210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,PROCESSING,PACKING, OR HOLDING OF DRUGS;GENERAL

210部分

人用及兽用药品的生产、包装或储存的现行药品生产质量管理规范

（通则）

目录

PART210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,PROCESSING, PACKING,OR HOLDING OF DRUGS;GENERAL

人用及兽用药品的生产、包装或储存的现行药品生产质量管理规范（通则） (1)

§210.1Status of current good manufacturing practice regulations CGMP

法规地位 (3)

§210.2Applicability of current good manufacturing practice regulations

CGMP法规的适用性 (4)

§210.3Definitions定义 (5)

§210.1Status of current good manufacturing practice regulations. CGMP法规地位

(a)The regulations set forth in this part and in parts211,225,and226of 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.

在本部分及本章的211、225、226部分陈述的法规包括了现行药品生产管理规范的最低要求，适用于药品生产、加工、包装或贮存中使用的方法、设施及控制；以确保该药品符合联邦食品、药品及化妆品法案（FFDCA）的安全性要求，药物的均一性及效价（含量）正确，具有其声称的或表明具有的质量及纯度属性。

(b)The failure to comply with any regulation set forth in this part and in parts211,225, and226of this chapter in the manufacture,processing,packing,or holding of a drug shall render such drug to be adulterated under section501(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、包装或储存过程中存在任何不符合本部分及21CFR211，225，226部分的法规，则依据FFDCA501(a)(2)(b)，该药品应视为伪劣药；并对该事故的责任人采取相应监管措施。

(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 section505of the act or under a biological product license application under section351of the Public Health Service Act),are subject to the donor-eligibility and applicable current good tissue practice procedures set forth in part1271subparts C and D of this chapter,in addition to the regulations in this part and in parts211,225,and 226of this chapter.Failure to comply with any applicable regulation set forth in this part, in parts211,225,and226of this chapter,in part1271subpart C of this chapter,or in part1271subpart D of this chapter with respect to the manufacture,processing,packing or holding of a drug,renders an HCT/P adulterated under section501(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FFDCA第505节的规定提交申请或按照《公共健康服务法案》第351节的规定提交生

物制品许可申请）。从事该类药品回收、捐献者筛选、检验（包括对捐献者的检验）、加工、贮藏、贴标、包装或销售的企业所有者和经营者，除受本部分法规及本章第211、225、226部分约束外，还应遵守本章第1271部分的C子部分和D子部分规定的捐献者合格性要求及适用的《现行良好组织操作规程》。在该类药品生产、加工、包装或贮存过程中，如存在任一不符合本部分，本章第211、225、226部分，本章第1271部分的C子部分或D子部分的项目，依据FFDCA第501节(a)(2)(B)，将该HCT/P视为伪劣药，并且对该事故责任人采取相应的监管措施。

[43FR45076,Sept.29,1978,as amended at69FR29828,May25,2004;74FR65431,Dec.10,2009]《联邦公报》43卷第45076页，1978年9月29日，《联邦公报》69卷第29828页修订，2004年5月25日；《联邦公报》74卷第65431页修订，2009年12月10日修订

§210.2Applicability of current good manufacturing practice regulations. CGMP法规的适用性

(a)The regulations in this part and in parts211,225,and226of this chapter as they may pertain to a drug;in parts600through680of this chapter as they may pertain to a biological product for human use;and in part1271of 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 section505of the act or under a biological product license application under section351of 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、225、226部分适用于药品的法规，本章600-680部分适用于人用生物制品的法规，以及本章1271部分适用于人类细胞、组织或是细胞组织底物产品（HCT/P）类药品（按照FFDCA第505节的规定提交申请或按照《公共健康服务法案》第351节的规定提交生物制品许可申请）的法规：以上法规应该是互相补充而不是互相取代的关系，法规另有明确规定的除外。如果本部分法规与本章其他法规均适用但有冲突，适用于所涉及产品的特别法规应替代普通法。

(b)If a person engages in only some operations subject to the regulations in this part,in parts211,225,and226of this chapter,in parts600through680of this chapter,and in part1271of 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.

如果一个人只参与本部分，本章的211、225、226部分，600-680部分，以及1271部分有要求的操作，而不参与其他部分的，这个人可以只遵守与他/她的操作适用的法规。

(c)An investigational drug for use in a phase1study,as described in§312.21(a)of this chapter,is subject to the statutory requirements set forth in21U.S.C.351(a)(2)(B).The production of such drug is exempt from compliance with the regulations in part211of this chapter.However,this exemption does not apply to an investigational drug for use in a phase1study once the investigational drug has been made available for use by or for the sponsor in a phase2or phase3study,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 phase2or phase3study or the drug has been lawfully marketed, the drug for use in the phase1study must comply with part211.

在本章§312.21(a)部分描述的用于第一阶段研究的试验性药品，应符合21U.S.C.（美国法典）351(a)(2)(B)中提出的法定要求。这类药品的生产免于符合本章第211部分的法规要求。但是，一旦用于第一阶段研究的试验性药品被申请者应用到第二、三阶段的研究中，如本章第§312.21(b)与(c)陈述的那样，或是药品已经合法上市，则这个豁免权不再适用。

[69FR29828,May25,2004,as amended at73FR40462,July15,2008;74FR65431,Dec.10,2009]《联邦公报》69卷第29828页，2004年5月25日，《联邦公报》73卷第40462页修订，2008年07月15日；《联邦公报》74卷第65431页修订，2009年12月10日修订

§210.3Definitions.

定义

(a)The definitions and interpretations contained in section201of the act shall be applicable to such terms when used in this part and in parts211,225,and226of this chapter.

在FFDCA201节中包含的定义和解释、说明适用于本章211，225，226部分中的术语。

(b)The following definitions of terms apply to this part and to parts211,225,and226of this chapter.

以下术语的定义适用于本部分，以及本章211，225，226部分。

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

法案（Act）指联邦食品、药品及化妆品法，修订版（21U.S.C301等）（简称FFDCA）

(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）（大批）指按照同一个生产指令在同一生产周期内生产出来的，具有同一性质及质量、符合规定限度的一定数量的药品或其他物料。

(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分，包括那些未在药品中出现的成分。

(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.

药物成品（Drug product）指成品制剂（如片剂、胶囊、溶液剂等），通常含有一种活性成份（但不是必需的），并伴有非活性成份。本术语也包括不含有活性成份、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）指所有长度大于其3倍宽度的微粒状污染物。

(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.

无纤维脱落过滤器（Non-fiber-releasing filter）指经过适当的预处理（如清洗或冲洗）后，不会在组分或药品过滤时发生纤维脱落的所有过滤器。

(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）是指所有在疾病的诊断、治愈、缓解、治疗或疾病预防中提供药理活性或其他直接作用的组分，或是影响人体或其他动物身体结构或功能的所有组分。本术语包括那些在药品生产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分。

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

非活性成份(Inactive ingredient)指除“活性成份”以外的所有组分。

(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.

中间体(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）（小批，亚批）指一批（同batch）或是一批（batch）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”（lot）指在单位时间或单位数量生产出的特定部分，并且确保该部分在指定的限度范围内具有均一的性质与质量属性。

(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)指所有由字母、数字、符号或它们的组合排列出的独特组合；根据批号可确定某一批药品或物料的生产、加工、包装、贮存或销售的完整情况。

(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、包装或贮存包括药品的包装、贴签操作、检验及质量控制。

(13)The term medicated feed means any Type B or Type C medicated feed as defined in §558.3of this chapter.The feed contains one or more drugs as defined in section201(g) of the act.The manufacture of medicated feeds is subject to the requirements of part225 of this chapter.

含药饲料（medicated feed）指在本章§558.3中定义的B型和C型含药饲料。正如FFDCA201(g)的定义，这种饲料含有一种或一种以上的药物。含药饲料的生产应符合本章225部分的要求。

(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 section201(g)of the act.The manufacture of medicated premixes is subject to the requirements of part226of this chapter.

加药预混料（medicated premix）指本章§558.3中定义的A型药用物质。正如FFDCA 201(g)的定义，该预混料含有一种或一种以上的药物。加药预混料的生产应符合本章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职责的所有人员或组织机构。

(16)Strength means:

效价/含量（Strength）：

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

原料药的含量（可表示为：以重量/重量、重量/体积、单位剂量/体积）；与/或

(ii)The potency,that is,the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed,for example,in terms of units by reference to a standard).

效价，即根据适当的实验室检测或足够的临床研究的可靠数据而得出的药品治疗活性（例如，可表达为对照于某标准，有多个少单位）。

(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）指某一特定药品，在生产、加工或包装的任一适用阶段，基于所使用的组分的数量，排除实际生产中的所有损失及错误，应能生产出的产品数量。

(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）指某一特定药品在生产、加工、包装的任一适用阶段实际生产出的产品数量。

(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）指某一特定药品在生产、加工或包装的任一适用阶段，实际产量与同阶段理论产量的比值，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）指附带取样检验方法的产品技术规格和接受/拒收标准，如可接受的质量水平及不可接受的质量水平；这是判定一小批或一整批（或以产出单元中便于表达的其他小集合表示）是否可以接受的必要依据。

(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）指包含若干按合理标准随机抽取的若干单位数量的样本，确保这类样本能准确代表被取样的物料。

(22)Gang-printed labeling means labeling derived from a sheet of material on which more than one item of labeling is printed.

拼版印刷贴标（Gang-printed labeling）指从同时印有一种以上标签的材料上得来的标签。

[43FR45076,Sept.29,1978,as amended at51FR7389,Mar.3,1986;58FR41353,Aug.3,1993; 73FR51931,Sept.8,2008;74FR65431,Dec.10,2009]

[《联邦公报》43卷第45076页，1978年09月29日，《联邦公报》51卷第7389页修订，1986年03月03日；《联邦公报》58卷第41353页，1993年08月03日；《联邦公报》73卷第51931页，2008年09月08日，《联邦公报》74卷第65431页，2009年12月10日]

PART211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

211部分

制剂产品的CGMP

目录

PART211CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

211部分制剂产品的CGMP (10)

Subpart A—GENERAL PROVISIONS

A.总则 (16)

§211.1Scope

范围 (16)

§211.3Definitions

定义 (17)

Subpart B—ORGANIZATION AND PERSONNEL

B.组织与人员 (17)

§211.22Responsibilities of quality control unit

质量控制部门的职责 (17)

§211.25Personnel qualifications

人员资质 (18)

§211.28Personnel responsibilities

人员职责 (19)

§211.34Consultants

顾问 (20)

Subpart C—BUILDINGS AND FACILITIES

C.建筑物与设施 (20)

§211.42Design and construction features

设计与建造特点 (20)

§211.44Lighting

照明 (22)

§211.46Ventilation,air filtration,air heating and cooling

通风、空气过滤、空气加热与冷却 (22)

§211.48Plumbing

管道 (23)

§211.50Sewage and refuse

污水及废弃物 (24)

§211.52Washing and toilet facilities

淋浴及厕所设施 (24)

§211.56Sanitation

卫生 (24)

§211.58Maintenance

维护与保养 (25)

Subpart D—EQUIPMENT

D.设备 (25)

§211.63Equipment design,size,and location

设备的设计、尺寸及位置 (25)

§211.65Equipment construction

设备构造 (26)

§211.67Equipment cleaning and maintenance

设备清洁与维护保养 (26)

§211.68Automatic,mechanical,and electronic equipment

自动化、机械化及电子设备 (27)

§211.72Filters

过滤器 (28)

Subpart E—CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES

E.组分、药品包装容器及密封件的控制 (29)

§211.80General requirements

一般要求 (29)

§211.82Receipt and storage of untested components,drug product containers,and closures

未检测组分、药品包装容器及密封件的接收与贮存 (30)

§211.84Testing and approval or rejection of components,drug product containers,and closures

组分、药品包装容器及密封件的检验，批准或拒收 (30)

§211.86Use of approved components,drug product containers,and closures

已批准组分、药品包装容器及密封件的使用 (33)

§211.87Retesting of approved components,drug product containers,and closures

已批准组分、药品包装容器及密封件的复验 (33)

§211.89Rejected components,drug product containers,and closures

组分、药品包装容器及密封件的拒收 (34)

§211.94Drug product containers and closures

药品包装容器及密封件 (34)

Subpart F—PRODUCTION AND PROCESS CONTROLS

F.生产及过程控制 (36)

§211.100Written procedures;deviations

书面程序；偏差 (36)

§211.101Charge-in of components

组分进料 (36)

§211.103Calculation of yield

产量计算 (38)

§211.105Equipment identification

设备标识 (38)

§211.110Sampling and testing of in-process materials and drug products 中间体及药物成品的取样与检验 (39)

§211.111Time limitations on production

生产时间限制 (40)

§211.113Control of microbiological contamination

微生物污染的控制 (40)

§211.115Reprocessing

返工 (41)

Subpart G—PACKAGING AND LABELING CONTROL

G.包装与标签控制 (41)

§211.122Materials examination and usage criteria

物料检查及使用标准 (41)

§211.125Labeling issuance

标签发放 (43)

§211.130Packaging and labeling operations

包装与标签操作 (44)

§211.132Tamper-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 (45)

§211.134Drug product inspection

成品检查 (49)

§211.137Expiration dating

有效期 (49)

Subpart H—HOLDING AND DISTRIBUTION

H.储存及销售 (50)

§211.142Warehousing procedures

仓储程序 (50)

§211.150Distribution procedures

销售程序 (51)

Subpart I—LABORATORY CONTROLS

I.实验室控制 (51)

§211.160General requirements

总体要求 (51)

§211.165Testing and release for distribution

检验及放行 (53)

§211.166Stability testing

稳定性试验 (54)

§211.167Special testing requirements

特殊检验要求 (56)

§211.170Reserve samples

留样 (56)

§211.173Laboratory animals

实验动物 (58)

§211.176Penicillin contamination

青霉素污染 (59)

Subpart J—RECORDS AND REPORTS

J.记录与报告 (59)

§211.180General requirements

一般要求 (59)

§211.182Equipment cleaning and use log

设备清洁及使用日志 (61)

§211.184Component,drug product container,closure,and labeling records

组分、药品包装容器、密封件及标签记录 (62)

§211.186Master production and control records

主生产及控制记录 (63)

§211.188Batch production and control records

批生产与控制记录 (64)

§211.192Production record review

生产记录的审核 (66)

§211.194Laboratory records

实验室记录 (66)

§211.196Distribution records

销售记录 (69)

§211.198Complaint files

投诉文件 (69)

Subpart K—RETURNED AND SALVAGED DRUG PRODUCTS

K.退回及回收药品 (71)

§211.204Returned drug products

退回药品 (71)

§211.208Drug product salvaging

回收药品 (71)

Subpart A—GENERAL PROVISIONS

A.总则

§211.1Scope.

范围

(a)The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products(excluding positron emission tomography drugs)for administration to humans or animals.

本部分的条例包含人用或兽用药品（不包括正电子发射断层扫描的药物）制备的最低限度的CGMP要求。

(b)The current good manufacturing practice regulations in this chapter as they pertain to drug products;in parts600through680of this chapter,as they pertain to drugs that are also biological products for human use;and in part1271of 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 section505of the act or under a biological product license application under section351of 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 parts600through680of this chapter,or in part1271of this chapter,the regulation specifically applicable to the drug product in question shall supersede the more general.

本章中针对药品的CGMP法规，本章600至680部分针对人用生物制品的CGMP法规，以及本章1271部分中适用于人类细胞、组织以及细胞组织底物产品（HCT/Ps）类药品（按照FFDCA第505节的规定提交申请或按照《公共健康服务法案》第351节的规定提交生物制品许可申请）的法规：以上法规应该是互相补充而不是互相取代的关系，法规另有明确规定的除外。如果本部分法规与本章其他法规，以及600-680部分，以及本章1271部分均适用但有冲突，适用于所涉及产品的特别法规应替代普通法。

(c)Pending consideration of a proposed exemption,published in the Federal Register of September29,1978,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 parts110 and117of this chapter,and where applicable,parts113through129of 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.

发表在1978年9月29日联邦公报（FR）上的一项悬而未决的豁免申请是，若OTC药品及其所有成份是以人用食品形式进行一般销售和消费，且这些药品根据其预期用途，亦可

列入药品的范围内，则这类OTC药可以免除本部分法规要求。因此，如果没有另行通知，本章的110部分与117部分，以及113部分至129部分（如适用）的条例应该用于判定这些既是OTC药品也是食品的产品，是否应按照CGMP的要求进行生产、加工、包装和贮存。

[43FR45077,Sept.29,1978,as amended at62FR66522,Dec.19,1997;69FR29828,May25,2004; 74FR65431,Dec.10,2009;80FR56168,Sept.17,2015]

略

§211.3Definitions.

定义

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

本章§210.3中陈述的定义适用于本部分

Subpart B—ORGANIZATION AND PERSONNEL

B.组织与人员

§211.22Responsibilities 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.

应设有质量控制部门，具有批准和拒收所有组分、药品包装容器、密封件、中间体、包装材料、标签及药物成品的职责与权力；具有复查生产记录的权力，确保没有差错产生，或者如果发生差错，保证对差错进行了彻底调查。质量控制部门还负责批准或拒收由其它合同公司生产、加工、包装或贮存的药物成品。

(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.

质量控制部门应配备恰当的实验室设施，用于检验及批准（或拒收）各种组分、药品包装

容器、密封件、包装材料，中间体及药物成品。

(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.

质量控制部门有责任批准或驳回所有影响成品均一性、效价（含量）、质量及纯度的程序或质量标准。

(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，应制订成书面程序并执行。

§211.25Personnel 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、包装或贮存的工作人员，应接受过教育、培训，具备相关经验，或是以上三项的任意组合，使他们有能力执行被委派的工作任务。雇员应接受其被指派操作的相关培训，以及与其职责相关的CGMP培训（包括本章中的CGMP条例和这些条例要求的书面程序）。由具备资质的人员进行持续的、足够频次的CGMP培训，保证雇员始终熟悉CGMP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、包装或贮存工作的每一个工作人员，应接受教育、培训，具备相关经验，或是以上三项的任意组合，来完成被委派的各项职能，以确保药品具有声称或表明具有的安全性、均一性、效价（含量）、质量及纯度属性。

(c)There shall be an adequate number of qualified personnel to perform and supervise the manufacture,processing,packing,or holding of each drug product.

有足够数量的合格人员执行和监督每种药品的生产、加工、包装或贮存过程。

§211.28Personnel 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、包装或贮存的人员，应穿着适合于其操作要求的洁净服。按需要在头部、脸部、手部、臂部穿戴防护衣物，防止药品受到污染。

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

人员应保持良好的个人卫生与健康习惯。

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

只有得到监管人员的授权，才能进入划为限制区域的建筑物及设施。

(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发现），明显地表现出有可能影响药品安全性或质量的疾病或开放性损伤，应避免直接接触各种组分、药品包装容器、密封件、中间体及药品，直至状况改善或是具有医学能力的人员认定其不会对药品的安全性及药品质量产生危害为止。应告知所有人员，如果发生任何可能对药品产生不良影响的健康状况，都必须向监督人员报告。

§211.34Consultants.

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.

药品生产、加工、包装或贮存相关领域的顾问，应接受过充分的教育及培训，具有相关的经验，或以上三项的任意组合，来对他们相应领域的问题提出建议。应保存包括所有顾问姓名、地址、资格证明，以及服务类型的记录。

Subpart C—BUILDINGS AND FACILITIES

C.建筑物与设施

§211.42Design and construction features.

设计与建造特点

(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.

任何用于某个药品生产、加工、包装或储存的建筑物或建筑群，应大小适宜，结构与位置便于清洁、维护保养以及执行恰当的操作。

(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.

所有这些建筑物应具备足够的空间来有序安装设备及放置物料，避免不同组分、药品包装容器、密封件、标签、中间体或成品混放，以防止污染。穿过建筑物或建筑群的上述物料，其流向设计应能防止污染。

(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:

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China covers a large territory and has many nationalities, hence a variety of Chinese food with different but fantastic and mouthwatering flavor. Since China's local dishes have their own typical characteristics, generally, Chinese food can be roughly divided into eight regional cuisines, which has been widely accepted around. Certainly, there are many other local cuisines that are famous, such as Beijing Cuisine and Shanghai Cuisine. 中国地域辽阔，民族众多，因此各种中国饮食口味不同，却都味美，令人垂涎。因为中国地方菜肴各具特色，总体来讲，中国饮食可以大致分为八大地方菜系，这种分类已被广为接受。当然，还有其他很多著名的地方菜系，例如北京菜和上海菜。 Shandong Cuisine 山东菜系 Consisting of Jinan cuisine and Jiaodong cuisine, Shandong cuisine, clear, pure and not greasy, is characterized by its emphasis on aroma, freshness, crispness and tenderness. Shallot and garlic are usually used as seasonings so Shangdong dishes tastes pungent usually. Soups are given much emphasis in Shangdong dishes. Thin soup features clear and fresh while creamy soup looks thick and tastes strong. Jinan cuisine is adept at deep-frying, grilling, frying and stir-frying while Jiaodong division is famous for cooking seafood with fresh and light taste. 山东菜系，由济南菜系和胶东菜系组成，清淡，不油腻，以其香，鲜，酥，软而闻名。因为使用青葱和大蒜做为调料，山东菜系通常很辣。山东菜系注重汤品。清汤清澈新鲜，而油汤外观厚重，味道浓重。济南菜系擅长炸，烤，煎，炒，而胶东菜系则以其烹饪海鲜的鲜淡而闻名。 Shandong is the birthplace of many famous ancient scholars such as Confucious and Mencius. And much of Shandong cuisine's history is as old as Confucious himself, making it the oldest existing major cuisine in China. But don't expect to gain more wisdom from a fortune cookie at a Shandong restaurant in the West since fortune cookies aren't even indigenous to China. 山东是许多著名学者的故乡，例如孔夫子和孟子。许多山东菜的历史和孔夫子一样悠久，使得山东菜系成为中国现存的最古老的主要菜系之一。但是不要期望在西方国家的山东菜馆里从签饼(中国餐馆的折叠形小饼,内藏有预测运气话语的纸条)获得更多的好运气，因为签饼在中国也不是本土的。 Shandong is a large peninsula surrounded by the sea to the East and the Y ellow River meandering through the center. As a result, seafood is a major component of Shandong cuisine. Shandong's most famous dish is the Sweat and Sour Carp. A truly authentic Sweet and Sour Carp must come from the Y ellow River. But with the current amount of pollution in the Y ellow River, you would be better off if the carp was from elsewhere. Shandong dishes are mainly quick-fried, roasted, stir-fried or deep-fried. The dishes are mainly clear, fresh and fatty, perfect with Shandong's own famous beer, Qingdao Beer

中国八大菜系代表作英文翻译

中国八大菜系代表作（英文翻译） No.1 Sichuan Cuisine Pockmarked bean curd Chicken cubes with peanuts Pork shreds with fishy flavour Translucent beef slices No. 2 Guangdong cuisine Roasted sucking pig Fricassee three kinds of snakes and cat Steamed turtle with chives sauce King snake with bamboo slices Gourd cups No. 3 Shandong Cuisine Dezhou grilled chicken Bird’s nest in a clear soup Quick-boiled clam Lotus flower and shrimp No. 4 Huaiyang Cuisine (also known as Weiyang Cuisine) Yincai vegetalbes cooked with chicken slices Crab meat & minced pork ball in casserole Chicken mousse broth with fresh corn Squid with crispy rice crust 川菜 麻婆豆腐 宫保鸡丁 鱼香肉丝 灯影牛肉 粤菜 烤乳猪 龙虎烩 清蒸甲鱼 笋片烧蛇 葫芦盅 鲁菜 德州扒鸡 清汤燕窝羹 油爆大蛤 荷花大虾 淮阳菜 蔬菜炒鸡片 砂锅蟹肉丸 奶油鸡丝玉米汤鱿鱼锅巴

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八大菜系英文版

鲁、川、粤、闽、苏、浙、湘、徽等菜系，即被人们常说的中国“八大菜系” 中国八大菜系之英文版 Eight Cuisines(八大菜系） China covers a large territory and has many nationalities, hence a variety of Chi nese food with different but fantastic and mouthwatering flavor. Since China's lo cal dishes have their own typical characteristics, generally, Chinese food can be roughly divided into eight regional cuisines, which has been widely accepted aro und. Certainly, there are many other local cuisines that are famous, such as Beij ing Cuisine and Shanghai Cuisine. Shandong Cuisine Consisting of Jinan cuisine and Jiaodong cuisine, Shandong cuisine, clear, pure a nd not greasy, is characterized by its emphasis on aroma, freshness, crispness an d tenderness. Shallot and garlic are usually used as seasonings so Shangdong dis hes tastes pungent usually. Soups are given much emphasis in Shangdong dishes. Thin soup features clear and fresh while creamy soup looks thick and tastes str ong. Jinan cuisine is adept at deep-frying, grilling, frying and stir-frying while Ji aodong division is famous for cooking seafood with fresh and light taste. Shandong is the birthplace of many famous ancient scholars such as Confucious and Mencius. And much of Shandong cuisine's history is as old as Confucious h imself, making it the oldest existing major cuisine in China. But don't expect to gain more wisdom from a fortune at a Shandong restaurant in the West since f ortune s aren't even indigenous to China. Shandong is a large peninsula surrounded by the sea to the East and the Yellow River meandering through the center. As a result, seafood is a major componen t of Shandong cuisine. Shandong's most famous dish is the Sweat and Sour Car p. A truly authentic Sweet and Sour Carp must come from the Yellow River. B ut with the current amount of pollution in the Yellow River, you would be bett er off if the carp was from elsewhere. Shandong dishes are mainly quick-fried, r oasted, stir-fried or deep-fried. The dishes are mainly clear, fresh and fatty, perfe ct with Shandong's own famous beer, Qingdao Beer Sichuan Cuisine pungent Sichuan Cuisine, known often in the West as Szechuan Cuisine, is one of the m ost famous Chinese cuisines in the world. Characterized by its spicy and pungen t flavor, Sichuan cuisine, prolific of tastes, emphasizes on the use of chili. Pepp er and prickly ash(花椒) also never fail to accompany, producing typical exciting tastes. Besides, garlic, ginger and fermented soybean （豆酱）are also used in t he cooking process. Wild vegetables and animals are usually chosen as ingredien

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College student career programming University student's career planning directly impact on university student's academic performance, and also affect the job hunting after graduation and even the success of future career。 As a junior ,career programming is a impetus for the future .Through three year’s college life ,we have fairly domain knowledge. Now we need to do career planning based on our major, structure of knowledge, combination social environment and market circumstances.Taking out a plan about will engaged in what career and require reach the career goal’s directivity. By means of myself’s career programming, I can solve the problem of four to decide -directional ,fixed point, fixed position,centering. Thereby, as soon as possible to sure my career goal,choose career development area and scope. As a girl, I want to live leisure life .To be a teacher for a girl is a good choice,but I don’t think I can be a good teacher. As a teacher I have no special vision, no special urge ,no fight. I know my respect fields well. I have orderly minds.My course may be well planed and efficiently taught.Because I am a responsible person.I am more interested in the subject being taught than in students or social progress. A good teacher is