(CGMP)美国药品生产质量管理规范(中英文对照完整

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(CGMP)美国药品生产质量管理规范(中英文对照完整版)(CGMP)美国药品生产质量管理规范(中英文对照完整版)

GOOD MANUFACTURE PRACTICE 

美国药品生产质量管理规范(CGMP)

二○○三年十二月


目     录



210.1

cGMP法规的地位……………………………………………………

2

210.2

cGMP法规的适用性…………………………………………………

2

210.3

定义…………………………………………………………………

2

211-A-

总则…………………………………………………………………

4

211-B-

组织与人员…………………………………………………………

4

211-C-

厂房和设施…………………………………………………………

5

211-D-

设备…………………………………………………………………

7

211-E-

成份、药品容器和密封件的控制…………………………………

8

211-F-

生产和加工控制……………………………………………………

10

211-G-

包装和标签控制……………………………………………………

11

211-H-

贮存和销售…………………………………………………………

13

211-I-

实验室控制…………………………………………………………

14

211-J-

记录和报告…………………………………………………………

16

211-K-

退回的药品和回收处理……………………………………………

20



210部分—人用及兽用药品

的生产、加工、包装或贮存的CGMP

Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

  210.1 cGMP法规的地位

§ 210.1 Status of current good manufacturing practice regulations.

  (a) 在本部分及21CFR 211—226部分中陈述的法规是在药品生产、加工、包装或贮存中使用的现行生产质量管理规范及使用的设施或控制的最低标准,以保证该药品符合联邦食品、药品及化妆品法对安全性的要求,具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征。

   (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.

(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。

(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.

  210.2 cGMP法规的适用性

§ 210.2 Applicability of current good manufacturing practice regulations.

(a) 本部分及21CFR 211—226适用于普通药品,21CFR 600—680适用于人用生物制品,除非另有明确规定,否则上述两者之间应该是相互补充而不是相互取代。如有上述两部分的法规不适用的药品,则可用特定的具体法规来替代。

(a) The regulations in this part and in Parts 211 through 226 of this chapter as they may pertain to a drug and in Parts 600 through 680 of this chapter as they may pertain to a biological product for human use, shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event that it is impossible to comply with all applicable regulations in these parts, the regulations specifically applicable to the drug in question shall supersede the more general.

(b) If a person engages in only some operations subject to the regulations in this part and in Parts 211 through 226 and Parts 600 through 680 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.

  210.3 定义

§ 210.3 Definitions.

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

(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.

(b) 下面定义的术语适用于本部分及21CFR 211—226。

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

   (1)法(Act)

   指联邦食品、药品及化妆品法,修订版(21 U.S.C 301 et seq.)。

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

(2)批(Batch)

指在规定限度内,按照某一生产指令在同一生产周期内生产出来的,具有同一性质和质量的一定数量的药品或其它物料。

(3)组分(Component)

指用于药品生产的所有成份,包括那些未在药品中出现的成份。

(4)药品(Drug Product)

指成品制剂(如:片剂、胶囊剂、口服液等),通常含有一种活性成份并伴有非活性成份(但不是必需的)。本术语也包括不含有活性成份但作为安慰剂使用的成品制剂。

  (5)纤维(Fiber)

  指长度大于其宽度的3倍的任何微粒状污染物。

  (6)无纤维脱落的过滤器(Non-fiber-releasing filter)

   指任何经过适当的预处理(如清洗或冲洗)后,不会将纤维脱落到已过滤的组分或药品中的所有过滤器。所有含石棉过滤器均被认为是有纤维脱落的过滤器。

  (7)活性成份(Active Ingredient)

   是指所有用于保证药物活性或其他在疾病的诊断、治愈、缓解、治疗或预防中起直接作用,或影响人或其他动物身体结构或功能的组分。本术语包括那些能承受药品生产中的化学变化和为了保证其指定的活性或作用以一种经调整的形式存在于药品中的组分。

  (8)非活性成份(Inactive ingredient)

   指不同于“活性成份”的其他组分。

  (9)中间产品(In-process material)

   是指所有经制备、复合、混合或由化学反应得到的用于药品生产或制备的物料。

  (10)批(lot)

   指一批或是一批中特定的均一部分,在指定的范围内具有相同的性质和质量;或者若为由连续的生产过程制造出的药品,“批”指在单位时间或单位数量生产出的特定的、均一的部分,并且确保该部分在指定的范围内具有均一性质与质量。

  (11)批号(Lot number, control number,batch number)

   指由字母、数字、符号或他们的组合组成,由此可确定某批药品或物料的生产、加工、包装、贮存或销售的情况。

  (12)药品的生产、加工、包装或贮存(Manufacture, processing, packing, or holding of a drug product)

   包括药品的包装和标签操作、检验、质量控制。

  (13)药用物料(medicated feed)

   指在21CFR 558.3中定义的B型和C型药用物料。该物料含有联邦食品、药品及化妆品法201(g)部分中定义的一种或一种以上的药物,药用物料的生产应符合21CFR 226部分中的要求。

  (14)药用预混合料(medicated premix)

   指21CFR 558.3中定义的A型药用物质。该预混合料含有联邦食品、药品及化妆品法201(g)部分中定义的一种或一种以上的药物。药用预混合料生产应符合21CFR 226部分中的要求。

  (15)质量控制部门(Quality control unit)

   指由企业任命负责质量控制相关责任的任何人员或组织机构。

  (16)含量或效价(Strength)

  指:

  (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)也即由适当的实验室检测或由足够的临床数据得出的指定的药品治疗活性(如:可表达为对照于某标准的单位的术语)。

  (17)理论产量(Theoretical yield)

   指在生产、加工或包装某种药品的任一适当阶段中,并且基于所使用的组分的数量在实际生产中无任何损失或错误的情况下,应能生产的数量。

  (18)实际产量(Actual yield)

  指某种药品在生产、加工、包装的任一适当的阶段实际生产出的数量。

  (19)比率(Percentage of theoretical yield)

  实际产量(生产、加工或包装某种药品的适当阶段)与理论产量(在相同阶段)的比率,以百分数表示。

  (20)验收标准(Acceptance criteria)

   建立在相应的取样方法基础上的药品的质量检验标准和合格、不合格标准(如合格质量水平和不合格的质量水平),是决定批准或拒收一批(或其他生产单元的小组)药品的必需因素。

  (21)代表性样品(Representative sample)

指一个样品按合理的标准抽取(如随机取样法),并包含若干单位(元),以能保证样品准确描绘被取样品的物料。

(2)Batchmeans 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.

(3)Componentmeans any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. (— p>

(4)Drug productmeans 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.

(5)Fibermeans any particulate contaminant with a length at least three times greater than its width.

(6)Non-fiber-releasing filtermeans any filter, which after any appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.

(7)Active ingredientmeans 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.

(8)Inactive ingredientmeans any component other than an ``active ingredient.''

(9)In-process materialmeans any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.

(10)Lotmeans 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.

(11)Lot number, control number, or batch numbermeans 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.

(12)Manufacture, processing, packing, or holding of a drug productincludes packaging and labeling operations, testing, and quality control of drug products.

(13) The termmedicated feedmeans 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.

(14) The termmedicated premixmeans 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.

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

(16)Strengthmeans:

(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).

(17)Theoretical yieldmeans 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.

(18)Actual yieldmeans the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.

(19)Percentage of theoretical yieldmeans 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.

(20)Acceptance criteriameans 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).

(21)Representative samplemeans 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.

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

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

EFFECTIVE DATE NOTE: At 58 FR 41353, Aug. 8, 1993, 210.3 was amended by adding paragraph (b)(22) effective Aug. 3, 1994.



A.总   则

Subpart A--General Provisions

211∙1范围

(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) 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) 在考虑经提议的,发表在1978年9月29日联邦注册表(FR)上一项免除时,若产品及其所有成份是以人用物品形式作一般销售和消费且这些产品根据其预期用途,亦可列入药品的范围内,则不应对这些非处方药(OTC)实施本部分条例,直至进一步的通知为止。本章110部分和113至119部分的条例用于鉴别这些变是食品的OTC药品是否按照GMP的要求生产、加工、包装和贮存。

Sec. 211.1 Scope.


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

(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.

(c) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.


211∙3定义

本章210∙3中的定义适用于本部分。

Sec. 211.3 Definitions.


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


B.组织与人员


211∙22质量控制部门的职责

(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) 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) 本部门有批准或驳回影响药品的均一性、效价或含量、质量及纯度的所有程序或规格标准的职责。

(d) 适用于本部门的职责与程序,应成文字材料,并应遵循。

211∙25人员资格

(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) 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) 有足够量招待和监督每种药品的生产、加工、包装或仓贮的合格人员。

211∙28人员职责

(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、臂部另外罩,防止药物受污染。

(b) 人员保持良好的个人卫生和健康。

(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) 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,直至监督人员结对药品有不利影响的健康情况。

211∙34顾问

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、任何的顾问资格及服务形式等履历资料。

Subpart B--Organization and Personnel

Sec. 211.22 Responsibilities of quality control unit.


(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.

(b) Adequate laboratory facilities for the testing and approval (or rejec

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