美国cGMP-中英文对照

PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING，PROCESSING，PACKING, OR HOLDING OF DRUGS；GENERAL
210部分有关于生产、加工、包装和药品的储存的现行GMP;一般准则
Sec. 210.1 Status of current good
manufacturing practice regulations。

210.1 cGMP的法规地位。

(a）The regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture，processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. （a）在本部分及本章第211－226部分中所陈述的法规,为现行GMP最低要求，适用于药品制造、加工、包装或贮存中所采用的方法及所使用的设施或控制手段,以保证该药品符合《联邦食品、药品及化妆品法案》（以下简称法案）对安全性的要求，具有均一性和效价（或含量)并符合或代表其生产过程的质量及纯度等特征。

(b）The failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture, processing, packing，or holding of a drug shall render such drug to be adulterated under section 501（a) (2）(B) of the act and such drug, as well as the person who is responsible for the failure to comply，shall be subject to regulatory action。

（b)凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211—226部分中陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a）（2)—(B），该药应被视为劣药，同时导致该事故发生的负责人应受相应的法规的制裁。

（c) Owners and operators of establishments engaged in the recovery, donor screening, testing （including donor testing)，processing, storage, labeling，packaging，or distribution of human cells, tissues, and cellular and tissue-based products (HCT/Ps)，as defined in 1271.3(d）of this chapter, that are drugs （subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act), are subject to the donor—eligibility and applicable current good tissue practice procedures set forth in part 1271 subparts C and D of this chapter, in addition to the regulations in this part and in parts 211 through 226 of this chapter. Failure to comply with any applicable regulation set forth in this part，in parts 211 through 226 of this chapter, in part （c)人类细胞、组织和细胞组织底物产品(HCT/Ps），根据本章§1271。

3(d)的定义属药品（按照《法案》第505节递交的申请或按照《公共健康服务法案》第351节进行的生物制品许可申请接受审核），从事该类药品回收、捐献者筛选、检验(包括捐献者检验）、加工、贮藏、贴标、包装或销售企业的所有者和经营者，除受本部分法规及21CFR第211－226部分约束外，还应受本章第1271部分的C子部分和D子部分陈述的捐献者合格性和适用
的《现行良好组织操作规程》的约束.在药品制造、加工、包装或贮存过程中，如存在不符合本部分及21CFR第211—226部分、21CFR 第1271部分的C子部分或21CFR第1271
部分的D子部分中任何法规的情况，依据《法案》第501节（a）(2)(B)，将该HCT/P视为劣药，并且对该HCT/P及事故责任人采取相应监管措施。

1271 subpart C of this chapter，or in part 1271
subpart D of this chapter with respect to the
manufacture，processing，packing or holding
of a drug, renders an HCT/P adulterated under
section 501（a）(2)（B）of the act。

Such HCT/P，
as well as the person who is responsible for the
failure to comply，is subject to regulatory
action。

Sec. 210。

2 Applicability of current good
manufacturing practice regulations。

210。

2 cGMP法规的适用性
（a）The regulations in this part and in parts 211 through 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use；and in part 1271 of this chapter as they are applicable to a human cell，tissue, or cellular or tissue—based product (HCT/P) that is a drug （subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act）; shall be considered to supplement，not supersede, each other, unless the regulations explicitly provide otherwise。

In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general. （a）本部分及21CFR211—226适用于普通药品，21CFR 600-680适用于人用生物制
品,21CFR 1271部分适用于人类的细胞、组织或是细胞组织底物产品（HCT/P) 类药品（按照《法案》第505节递交的申请或按照《公共健康服务法案》第351节进行的生物制品许可申请接受审核），它们之间应该是相互补充而不是相互取代，法规另有明确规定除外。

在适用本部分法规和21CFR其它部分法规发生冲突的情况下,特别法规应替代普通法规适用于所涉及的药品.
（b）If a person engages in only some operations subject to the regulations in this part，in parts 211 through 226 of this chapter, in parts 600 through 680 of this chapter，and in part 1271 of this chapter, and not in others，that person need only comply with those regulations applicable to the operations in which he or she is engaged. （b）如果一个人的具体操作仅涉及到21CFR 中的本部分，211到226部分，600到680部分和1271部分，而不参与到其他部分中，这个人仅仅需要遵守他/她所涉及的相关操作的规范。

（c) An investigational drug for use in a phase 1 study，as described in 312.21（a）of this chapter, is subject to the statutory requirements set forth in 21 U.S。

C。

351(a)(2）(B)。

The production of such drug is exempt from compliance with the regulations in part (c）在21CFR 312。

21(a）部分描述的要调查的第一阶段研究的药品要服从在21 U.S.C. 51（a）(2）(B)中陈述的法规要求。

这种药物的生产可以免除21CFR第211部分法规的要求。

然而，一旦这个要调研的新药可以被申请者应用到第二，三阶段的研究中，如本章中312。

21
211 of this chapter。

However，this exemption does not apply to an investigational drug for use in a phase 1 study once the investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3 study，as described in 312。

21（b) and (c) of this chapter，or the drug has been lawfully marketed。

If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed，the drug for use in the phase 1 study must comply with part 211. （b）&(c)描述的那样,或是药品已经合法上市,那前面所述的第一阶段的一个要调研用药并不适用于免除。

如果调研用药已经在第二阶段和第三阶段中应用或是药品已经合法上市了,那么药品的第一阶段的研究必须遵守211部分的要求。

[69 FR 29828，May 25, 2004，as amended at
73 FR 40462，July 15，2008］
Sec. 210.3 Definitions. 210.3定义
（a）The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 through 226 of this chapter。

（a)在联邦食品、药品及化妆品法201部分中包含的定义和解释、说明适用于部分及21CFR 211-226部分中的术语。

(b) The following definitions of terms apply to this part and to parts 211 through 226 of this chapter。

（b)下面术语的定义同样适用于本部分及21CFR 211—226部分中的术语
(1) Act means the Federal Food，Drug，and Cosmetic Act，as amended (21 U。

S。

C. 301et seq。

）。

（1)法案
指联邦食品、药品及化妆品法，修订版(21 U。

S。

C 301 et seq.)。

(2) Batch means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits，and is produced according to a single manufacturing order during the same cycle of manufacture。

（2）批
指在规定限度内，按照某一生产指令在同一生产周期内生产出来的，具有同一性质和质量的一定数量的药品或其它物料.
(3) Component means any ingredient intended for use in the manufacture of a drug product，including those that may not appear in such drug product。

（3）组份
指用于药品生产过程中的所有成份,包括那些未在药品中出现的成份.
(4) Drug product means a finished dosage form，for example, tablet, capsule, solution, etc。

，that contains an active drug ingredient generally, but not necessarily，in association with inactive ingredients. The term also （4）药品
指成品制剂(如：片剂、胶囊剂、溶液等），通常含有一种活性成份并伴有非活性成份（但不是必需的)。

本术语也包括不含有活性成份但作为安慰剂使用的成品制剂.
includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.
(5) Fiber means any particulate contaminant with a length at least three times greater than its width. （5）纤维
指长度大于其宽度的3倍的任何微粒状污染物.
(6) Non fiber releasing filter means any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered。

（6）无纤维脱落过滤器
指任何经过适当的预处理(如清洗或冲洗）后，不会将纤维脱落到已过滤的组份或药品中的过滤器。

(7) Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation，treatment，or prevention of disease，or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. （7)活性成份
是指任何具有药物活性或其他在疾病的诊断、治愈、缓解、治疗或预防中起直接作用，或影响人或其他动物身体结构或功能的组份。

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

(8) Inactive ingredient means any component other than an active ingredient.（8）非活性成份
指不同于“活性成份"的其他任何组份.
(9) In—process material means any material fabricated, compounded，blended, or derived by chemical reaction that is produced for，and used in, the preparation of the drug product。

(9）中间体
是指所有经制备、化合、混合或经由化学反应得到的用于药品生产的物料。

(10) Lot means a batch，or a specific identified portion of a batch, having uniform character and quality within specified limits；or，in the case of a drug product produced by continuous process，it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits。

（10)批
指一批或是一批中特定的均一部分,在指定的范围内具有相同的性质和质量；或者若为由连续的生产过程制造出的药品，“批”指在单位时间或单位数量生产出的特定的、均一的部分，并且确保该部分在指定的范围内具有均一的性质和质量。

(11) Lot number，control number, or batch number means any distinctive combination of letters, numbers, or symbols, or any （11）批号
指由字母、数字、符号或他们的组合构成，由此可确定某批药品或物料的生产、加工、包装、
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.
贮存或销售的情况。

(12) Manufacture，processing, packing, or holding of a drug product includes packaging and labeling operations, testing，and quality control of drug products. （12)药品的生产、加工、包装或贮存
包括药品的包装和标签操作、检验、质量控制.
(13) The term medicated feed means any Type B or Type C medicated feed as defined in 558.3 of this chapter. The feed contains one or more drugs as defined in section 201（g) of the act. The manufacture of medicated feeds is subject to the requirements of part 225 of this chapter. （13)药用物料
指在21CFR 558。

3中定义的B型和C型药用物料。

该物料含有联邦食品、药品及化妆品法201（g)部分中定义的一种或一种以上的药物，药用物料的生产应符合21CFR 225部分中的要求。

(14) The term medicated premix means a Type A medicated article as defined in 558。

3 of this chapter。

The article contains one or more drugs as defined in section 201（g) of the act. The manufacture of medicated premixes is subject to the requirements of part 226 of this chapter. （14）药用预混合料
指21CFR 558.3中定义的A型药用物料。

该预混合料含有联邦食品、药品及化妆品法201(g）部分中定义的一种或一种以上的药物。

药用预混合料生产应符合21CFR 226部分中的要求。

(15) Quality control unit means any person or organizational element designated by the firm to be responsible for the duties relating to quality control。

（15)质量控制部门
指由企业任命负责质量控制相关责任的任何人员或组织机构。

(16) Strength means:
（i）The concentration of the drug substance （for example，weight/weight, weight/volume，or unit dose/volume basis）, and/or
(ii) The potency，that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data （expressed，for example，in terms of units by reference to a standard）. （16）规格
（Ⅰ）原料药的浓度(如:以重量/重量、重量/体积、单位剂量/体积为基础);和/(或）
（Ⅱ）活性（效价)即根据适当的实验室检测或足够的临床研究可靠数据而得出的药品治疗活性(例如可表达为相当于多少单位的标准物质）。

(17) Theoretical yield means the quantity that would be produced at any appropriate phase of manufacture，processing, or packing of a （17）理论产量
指在生产、加工或包装某种药品的任一适当阶段中，并且基于所使用的组份的数量在实际生
[Code of Federal Regulations］
[Title 21, Volume 4]
［Revised as of April 1，2009]
[CITE: 21CFR211］
TITLE 21-—FOOD AND DRUGS
CHAPTER I——FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS
Subpart A-—General Provisions A——总则
Sec. 211。

1 Scope. 211.1范围
（a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals。

（a）本部分的条例包含人用或兽用药品制备的最低限度的现行药品生产质量管理规范(GMP)
（b）The current good manufacturing practice regulations in this chapter as they pertain to drug products; in parts 600 through 680 of this chapter，as they pertain to drugs that are also biological products for human use；and in part 1271 of this chapter，as they are applicable to drugs that are also human cells，tissues, and cellular and tissue—based products （HCT/Ps）and that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act）；supplement and do not supersede the regulations in this part unless the regulations explicitly provide otherwise。

In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter，the regulation specifically applicable to the drug product in question shall supersede the more general. （b）在21CFR里的这些针对普通药品的现行GMP条例和21CFR 600至680的所有部分针对人用生物制品的现行GMP条例，在21CFR 的1271部分中，法规适用于人类细胞,组织和细胞组织为底物的产品（HCT/Ps）和一些药品，这些药品（符合《法案》505部分的关于提交申请的审核部分或是《公共健康服务法案》351部分的生物产品申请许可）除非明确另有说明者外，应认为是对本部分条例的补充，而不是代替。

在21CFR的这部分和其他部分，或者是在21CFR的600到680的部分，或是1271部分法规有发生冲突的情况下,则可用存在争议药品的特定具体的法规来替代一般性的。

（c) Pending consideration of a proposed exemption，published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods，and which products may also fall within the legal definition of drugs by virtue of their intended use。

Therefore，until further notice, regulations under part 110 of this chapter, and where applicable，parts 113 to 129 of this chapter，shall be applied in determining whether these OTC drug products （c）在考虑经提议的，发表在1978年9月29日联邦注册表（FR）上的一个免除项是，若产品及其所有成份是以人用食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.21CFR 110部分和113至119部分的条例用于鉴别这些OTC药品是否按照GMP的要求生产、加工、包装和贮存。

that are also foods are manufactured,
processed，packed，or held under current
good manufacturing practice.
Sec. 211。

3 Definitions 211.3定义
The definitions set forth in 210。

3 of this chapter
apply in this part.
21CFR 210∙3中解释的定义适用于本部分
Subpart B—-Organization and Personnel B—-组织机构和人员
Sec。

211。

22 Responsibilities of quality control
unit.
211.22质量控制部门的职责
（a）There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures，in-process materials, packaging material，labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated。

The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed，packed, or held under contract by another company。

（a）需建立质量控制部门，本部门有批准和拒收所有组份、药品包装容器、密封器、中间体、包装材料、标签及药品的职责与权力,审核生产记录的权力，保证不产生差错，或若发生差错,保证他们充分调查.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）质量控制部门要可以获得足够的实验室设备用于检验和批准（或拒收）各种组份、药品容器、密封器、包装材料及中间体。

（c）The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength，quality，and purity of the drug product. （c）本部门有批准或驳回影响药品的均一性、规格、质量和纯度的所有程序或质量标准的职责。

（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,应成文件，并应遵循执行。

Sec。

211.25 Personnel qualifications. 211。

25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 (a)每位从事药品生产、加工、包装或储存工作人员，应接受培训、教育及有实践经验，完成委派的各项任务。

培训是按照现行GMP(包括21-CFR 211部分中的现行GMP条例和这些条
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. 例要求的文件）中涉及员工的职能。

邀请有资质的人员指导，并连续多次培训,保证员工熟悉现行GMP对他们的要求。

(b）Each person responsible for supervising the manufacture，processing, packing，or holding of a drug product shall have the education，training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety，identity，strength, quality，and purity that it purports or is represented to possess。

（b)负责监督药品的生产、加工、包装或储存工作的每一个工作人员,应受教育、培训及有经验,来完成委派的各项任务。

以此作为提供药品具有安全性、均一性、规格、质量及纯度的保证。

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

(c）有足够人数的合格员工进行和监督每种药品的生产、加工、包装或储存。

Sec. 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、包装或储存的人员，应穿着适合于其工作的清洁服装。

必要时应佩戴保护性用品，如头部、脸部、手部、臂部要戴上遮护用品,防止药物受污染。

（b）Personnel shall practice good sanitation
and health habits.
(b）人员要保持良好的个人卫生和健康习惯.
（c）Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited—access areas. （c）只有经监督人员授权的人员才可以进入建筑物和设施的限制区域。

（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, （d）任何人,在任何时间（无论是通过医学检查或是监控观察），患有危及药品安全性和质量的疾病或开放性损伤,都应避免接触各种组份、药品容器、包装设备、密封器、中间体和最终产品，直至健康状况已恢复或是有资格的医学人员确认该员工不会对药品安全性和质量有危
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。

害。

所有的人员都要被告知如果发生任何可能对药品产生不良影响的健康状况，都要向相关的监管人员报告。

Sec. 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。

顾问应对药品生产、加工、包装或储存提出建议，他们要受过足够的教育、培训,且有丰富的实践经验,来对他们在行的领域问题提出建议.顾问的姓名、地址、资格证明及所提供服务形式等资料要保存。

Subpart C——Buildings and Facilities C-—建筑和设施
Sec。

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 operations。

（a）任何用于某类药品生产、加工、包装或储存的厂房或建筑群，大小要适宜，结构与选址要使其易于清洁、保养、适合操作。

（b）Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between different components, drug product containers, closures，labeling，in—process materials, or drug products, and to prevent contamination. The flow of components, drug product containers，closures，labeling, in-process materials，and drug products through the building or buildings shall be designed to prevent contamination. （b）建筑物有足够空间来有条理地摆放设备和物料,避免不同类的组份、药品容器、密封器、标签、中间体或药品等相互混放，防止污染。

通过厂房的上述物料其流向在设计时要防止污染。

(c）Operations shall be performed within specifically defined areas of adequate size。

There shall be separate or defined areas or su ch other control systems for the firm’s operations as are necessary to prevent contamination or mixups during the course of the following procedures：（c)操作应在明确规定的、大小适中的区域内进行。

在下列操作过程中，操作要分开，在特定的区域或其他控制系统中进行,这个对于防止污染或是混淆是必要的。

(1) Receipt，identification，storage, and （1)放行给生产或包装前，由质量控制部门取
withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling，testing，or examination by the quality control unit before release for manufacturing or packaging; 样、检测和检查期间，药品的组份、容器、密封器及标签，监督接收、鉴别、储存及拒收过程：
(2) Holding rejected components, drug product containers, closures，and labeling before disposition；(2）拒收组份、药品容器、密封器及标签处理前的储存过程；
（3）Storage of released components，drug product containers，closures，and labeling; （3）已放行的组份、药品容器、密封器及标签的储存；
(4）Storage of in—process materials; (4）中间体的储存；
(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 products;
（7）药品放行前的待验隔离储存；（8) Storage of drug products after release; （8)放行后药品的储存；
(9) Control and laboratory operations；（9）控制与实验室的操作;
（10) Aseptic processing, which includes as
appropriate：
(10)无菌操作过程,包括如下适宜的操作；
（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)不管是层流或非层流，空气在正压下经高效过滤器过滤；
（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)用来创造无菌条件的房间和设备清洁、消毒的系统；
（vi）A system for maintaining any equipment
used to control the aseptic conditions。

（vi)用来控制无菌环境的设备维修的系统；
(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、加工及包装的操作所用设备与生产其他人用药品的设备分开；
[43 FR 45077，Sept。

29, 1978，as amended
at
60 FR 4091，Jan. 20，1995］
Sec. 211。

44 Lighting 211.44照明。

Adequate lighting shall be provided in all
areas。

所有区域均须提供充足的照明
Sec. 211。

46 Ventilation, air filtration, air 211。

46通风、空气过滤、空气加热及冷却
heating and cooling。

(a）Adequate ventilation shall be provided. (a）应提供足够的通风
(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)提供足以控制空气压力、微生物、灰尘、温度和湿度的设备,来适应药品生产、加工、包装和储存需要.
(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)适当的时候，应对输送至生产区域的空气使用空气过滤系统,该系统包括预过滤器和微粒物质空气过滤器.如果空气再循环到生产区，应采取措施控制来自生产的灰尘循环。

在生产过程中有空气污染的区域，应该有充足的排风系统或其他系统来控制污染。

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

（d)青霉素生产、加工和包装的空调系统应与其他人用药品的空调系统完全分开.
Sec。

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 Env ironmental 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，对药品无污染的管道系统内供应，这个管道系统内应没有可能导致药品污染的缺陷。

饮用水应符合环境保护机构制订的“基本饮用水条例”标准(40CFR141部分）。

不符合该标准的水，不许进入饮用水系统。

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

（b）排水设备应有足够的大小，在直接连接至下水道的地方应该提供空断或其他机械设备以防止发生倒虹吸.
［43 FR 45077，Sept。

29，1978，as
amended at 48 FR 11426, Mar. 18，1983]
Sec. 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。

进入和流出建筑物和附近区域的污水、垃圾及其他废物应用安全、卫生的方法处理。

Sec. 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, 提供足够的洗涤和盥洗设备，包括冷热水、肥皂或清洁剂、空气干燥器或是专用毛巾和干净的盥洗设备，以便进入工作区域.
and clean toilet facilities easily accesible to
working areas.
Sec. 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）用于药品生产、加工、包装及储存的建筑应保持清洁、卫生的环境，这种建筑不能有啮齿动物、鸟类、昆虫及其他害虫侵害（实验动物除外)。

垃圾和有机废料要及时采用对环境无危害的方法处理。

（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）制定并执行程序来分配清洁职责，详细描述清洁计划、方法、设备、清洁厂房和设施的材料。

（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）制定并执行程序来规定适用的灭鼠剂、杀虫剂、杀真菌剂、熏蒸剂、去垢剂和消毒剂应用的操作过程。

本程序设计是防止这些物品对设备、组份、药品容器、密封器、包装材料、标签或药品产生污染。

除依据联邦灭鼠剂、杀虫剂、杀真菌剂法规(7U。

S.C135）已登记和使用的品种外，其他的杀虫剂、杀真菌剂及杀鼠剂不能使用。

(d) Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations. (d)卫生程序要在合同工和临时工的工作中执行，同时也要在全职工作人员日常操作中执行。

Sec. 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、包装或储存的建筑应处于一种保持良好的保养状态。

Subpart D——Equipment D-—设备
Sec。

211.63 Equipment design，size，and
location.
211.63设备的设计、尺寸及位置Equipment used in the manufacture, 药品生产、加工、包装或储存中使用的设备，。