FDA GLP

1782626

Food and Drug Administration, HHS

§SOURCE: 43 FR 60013, Dec. 22, 1978, unless otherwise noted.

Subpart A—General Provisions

A部分——一般规定

§ 58.1 Scope.

58.1范围

(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies

本部分描述了适用于非临床化验室研究的GLP，

that support or are intended to support applications for research or marketing permits for

其支持或将会支持拟通过FDA批准的药品申请。

products regulated by the Food and Drug Administration, including food and color additives,

包括食品和色素添加剂

animal food additives, human and animal drugs, medical devices for human use, biological

动物食品和添加剂，人用和兽用药品，人用医疗器械

products, and electronic products. Compliance with this part is intended to assure the quality and

生物制剂和电子产品。符合本部分将会确保质量和安全数据的完整性

integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512–516, 518–520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354–360F of the Public Health Service Act.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999]

本部分参考21CFR I部分。

§ 58.3 Definitions.

58.3定义

As used in this part, the followingterms shall have the meanings specified:

本部分用到的术语以下定义：

(a)  Act  means the Federal Food,Drug, and Cosmetic Act, as amended(secs. 201–902, 52 Stat. 1040  et seq.,  asamended (21 U.S.C. 321–392)).

（a）行动 意思是联邦食品、药品和化妆品行动

(b)  Test article means any food additive, color additive, drug, biologicalproduct, electronic

（b）检验规章 意思是任何食品添加剂、色素添加剂、药品、生物制剂、电子产品、

product, medical device for human use, or any other article subject to regulation under the act or

人用医疗器械或其他任何用于符合公共健康服务的要求或符合公共健康服务行动351和354-360部分的规定。

under sections 351 and 354–360Fof the Public Health Service Act.

(c) Control article means any food additive, color additive, drug, biological product, electronic

(c)控制规章 意思是任何食品添加剂、色素添加剂、药品、生物制剂、电子产品、

product, medical device for human use, or any article other than a test article, feed, or water that is

人用医疗器械、或其他任何不同于检验的规章，种子、或水用于非临床化验室研究阶段的检验体系，目的是建立一个可以和检验规章相比较的基础。

administered to the test system in the course of a nonclinical laboratory study for the purpose of establishing a basis for comparison with the test article.

(d) Nonclinical laboratory study means in vivo or in vitro experiments inwhich test articles are

(d)非临床实验室研究  预先在实验室条件下进行体外或体内试验研究来确定他们的安全性。

studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals.

这个阶段并不包括对人或临床或动物研究。

The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article.

这个阶段不包括对试验规章是否有潜在的功效或确定其物理或化学特性的基础探索研究。

(e)  Application for research or marketing permit includes:

（e）销售或研究允许申请包括：

(1) A color additive petition, described in part 71.

（1）色素添加剂申请，71部分有描述。

(2) A food additive petition, described in parts 171 and 571.

（2）食品添加剂申请，171和571部分有描述。

(3) Data and information regarding a substance submitted as part of the procedures for establishing that a substance is generally recognized as safe for use,

原料药的有关数据和信息，作为提交程序的一部分，为了建立原料药的安全使用证明，

which use results or may reasonably be expected to result, directly or indirectly, in its becoming a

这些使用数据或将用建立的数据，直接或间接影响其所组成的食物的特性，在170.35和570.35有描述。

component or otherwise affecting the characteristics of any food, described in §§ 170.35 and 570.35.

(4) Data and information regarding a food additive submitted as part of the procedures regarding food additives permitted to be used on an interim basis pending additional study, described in § 180.1.

食品添加剂可以作为一部分使用的研究在180.1有描述。

(5) An investigational new drug application,  described in part 312 of this chapter.

IND申请在312部分有描述。

(6) A new drug application,  describedin part 314.

ND申请在314部分有描述。

(7) Data and information regarding an over-the-counter drug for human use, submitted as part of the procedures for classifying such drugs as generally recognized as safe and effective and not misbranded, described in part 330.

OTC药品在330部分有描述。

(8) Data and information about a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in parts 109 and 509.

原料药在109和509部分有描述。

(9) [Reserved]

（9）保留

(10) A Notice of Claimed Investigational Exemption for a New Animal Drug,  described in part 511.

(11) A new animal drug application, described in part 514.

(12) [Reserved] (13) An  application for a biologics license, described in part 601 of this chapter.

(14) An application for an investigational device exemption, described in part 812.

(15) An Application for Premarket Approval of a Medical Device, described in section 515 of the act.

(16) A Product Development Protocol for a Medical Device,  described in section 515 of the act.

(17) Data and information regarding a medical device submitted as part of the procedures for classifying such devices, described in part 860.

(18) Data and information regarding a medical device submitted as part of the procedures for establishing, amending,or repealing a performance standard for such devices, described in part 861.

(19) Data and information regarding an electronic product submitted as part of the procedures for obtaining an exemption from notification of a radiation safety defect or failure of compliance with a radiation safety performance standard, described in subpart D of part 1003.

(20) Data and information regarding an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for such product, described in section 358 of the Public Health Service Act.

(21) Data and information regarding an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard as described in§ 1010.4.

(22) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from any electronic product performance standard, as described in § 1010.5.

(23) A premarket notification for a food contact substance, described in part 170, subpart D, of this chapter.

(f) Sponsor means:

担保人：

(1) A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study;

对非临床研究提供资金或其他支持的人。

(2) A person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit; or

向FDA提交非临床研究以支持允许研究或销售的申请的人。

(3) A testing facility, if it both initiates and actually conducts the study.

一个检验设施，如果它既开始并确实也执行这个研究。

(g)  Testing facility  means a person who actually conducts a nonclinical laboratory study, i.e.,

检验设施 意思是一个人他实际上在执行一个非临床试验室研究，即实际上在一个检验体系内使用这个检验规章。

actually uses the test article in a test system. Testing facility  includes any establishment required

检验设施包括任何建立要求来注册在510部分执行非临床实验室研究的行动和任何在704部分描述的咨询实验室。

to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility  encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies.

检验设施只包括那些将要或已经用于执行非临床实验室研究的操作单元。

(h)  Person  includes an individual, partnership, corporation, association,scientific or academic establishment,government agency, or organizational unit thereof, and any other legal entity.

人，包括一个独立的、组织、协作科学的或学术机构，或其他的机构单元，和任何其他合法的实体。

(i)  Test system  means any animal,plant, microorganism, or subparts thereof to which the test or control article is administered or added for study.

检验体系 意思是任何动物、植物、微生物或其他用于检验或控制规章管理或增加的研究。

Test system  also includes appropriate groups or components of the system not treated with the test or con-trol articles.

检验体系也包括适当的不用于检验或控制规章的群体或组分

(j)  Specimen means any material derived from a test system for examination or analysis.

样品的意思是任何从检验体系中分离出来的用于检验或分析的材料。

(k)  Raw data  means any laboratory worksheets, records, memoranda, notes, or exact copies thereof,

原始数据 意思是任何实验室工作表、记录、备忘录、便签或其他准确的复印件。

that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study.

这些就是非临床实验室研究的原始发现和操作的结果，并且对于再现和评估研究报告是必要的。

In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature),

当原始数据的准确复印件准备好的情况下时（例如，应经逐字复制的录像带，注明日期，并经签字确认）

the exact copy or exact transcript may be substituted for the original source as raw data.

这样的复印件或录像带可替代原始资料作为原始数据。

Raw data  may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.

原始数据可包括图谱、微型胶卷/片复印件、电脑打印材料、磁碟，包括口述发现，来自于自动化仪器的记录数据。

(l)  Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies.

质量保证单元意思是任何人或组织，除了研究的指导者，在非临床实验研究中实施与质量保证有关的活动。

(m)  Study director  means the individual responsible for the overall conduct of a nonclinical laboratory study.

研究指导者意思是独立负责整个非临床实验室研究的人。

(n)  Batch  means a specific quantity or lot of a test or control article that has been characterized according to§ 58.105(a).

批的意思是一个确定的质量或已经符合58.105特征的试验批或控制规章。

(o)  Study initiation date means the date the protocol is signed by the study director.

研究开始日期意思是研究者签名批准报告的日期。

(p)  Study completion date  means the date the final report is signed by the study director.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 54 FR 9039, Mar. 3,

1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729, May 21, 2002]

§ 58.10 Applicability to studies performed under grants and contracts.

58.10合同和准许下的研究适用性

When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed

当一个担保人实施一个打算提交或被FDA审查的非临床实验室研究利用合同实验室、合同商或受让人实施的一个分析或其他服务，应该注意到合同实验室，合同商或受让人的服务作为非临床研究的一部分必须符合本部分内容。

by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part.

§ 58.15 Inspection of a testing facility.

58.15检验设备设施的检查

(a) A testing facility shall permit an authorized employee of the Food and Drug Administration,

检验场所应该允许FDA成员在适当的时间和适当的方式下对检验设施和检验记录（复印记录）进行检查，并且应该允许保留要求的样品在本部分范围内进行研究。

at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies within the scope of this part.

The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken.

记录检查和复印要求应不适用于质量保证单元发现和问题的记录，或者是采取修改行动。

(b) The Food and Drug Administration will not consider a nonclinical laboratory study in support of an application for a research or marketing permit if the testing facility refuses to permit inspection.

FDA不会认可一个拒绝接受检查的检验场所作为支持允许研究或销售申请的非临床实验室研究。

The determination that a nonclinical laboratory study will not be considered in support of anapplication for a research or marketing permit does not,

这个不被认可的决定不会减轻任何一个这样的允许申请在任何申请的程度下或提交研究结果给FDA。

however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to the Food and Drug Administration.

Subpart B—Organization and Personnel

B部分——组织和人员

§ 58.29 Personnel.

58.29人员

(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.

组织内任何一个独立的雇员或监督人员应有教育、培训、经验或其他知识，使能够独立的执行操作。

(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.

每个检验场所应该保存一个对非临床实验室研究中每一个独立岗位或监督岗位现行的培训、经验和工作描述总结。

(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.

根据本报告应该有足够数量的人员能够及时并适当的进行研究。

(d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems.

人员应当进行必要的个人卫生和健康注意以避免对检验和控制系统、检验体系的交叉污染。

(e) Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform.

非临床化验室研究人员应穿戴适合操作的服装。

Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles.

应该按照必要的周期进行服装更换，以此来避免微生物、放射物或化学污染。

(f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems,

任何时间发现任何人有可能不利于质量和非临床实验室研究完整性的疾病应该被排除于直接接触检验体系。

test and control articles and any other operation or function that may adversely affect the study until the condition is corrected.

任何可能影响研究的检验和控制规章和其他任何操作直到条件被纠正。

All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a nonclinical laboratory study.

所有的人员应该被指导报告他们的直接监督人员任何可能会影响非临床实验室研究的健康或药物因素。

§ 58.31 Testing facility management.

58.31检验管理管理

For each nonclinical laboratory study, testing facility management shall:

对于每个非临床化验室研究，检验设施的研究应该：

(a) Designate a study director as described in § 58.33, before the study is initiated.

（a）研究开始之前指定一个58.33描述的研究指导人员

(b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.

(b)研究过程中如有必要应迅速替换研究指导员。

(c) Assure that there is a quality assurance unit as described in § 58.35.

(c)确保有58.35描述的质量保证单元。

(d) Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.

(d)确保实验和控制规章或混合物应经适当的进行鉴别、含量、纯度、稳定性和一致性的检验。

(e) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled.

确认人员，资源，设施，设备，物料和方法已经按计划提供。

(f) Assure that personnel clearly understand the functions they are to perform.

确认操作人员清楚的理解他们将要实施的操作。

(g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.

确认质量保证单元已将任何偏差报告给研究指导员并且已经采取纠偏行动并将此记录在案。

[43 FR 60013, Dec. 22, 1978, as amended at 52

FR 33780, Sept. 4, 1987]

§ 58.33 Study director.

58.33研究指导员

For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director.

对于任何非临床实验室研究，一个科学家或其他有适当教育、培训、经验或其他知识的专家应该作为指导员。

The study director has overall responsibility for the technical conduct of the study, as well as for the interretation, analysis, documentation and reporting of results, and represents the single point of study control.

研究指导员对研究负有整体的技术责任，也负责解释、分析，检验结果的文件化和报告，并代表研究控制的一点。

The study director shall assure that:

研究指导员应确保以下：

(a) The protocol, including any change, is approved as provided by § 58.120 and is followed.

（a）包括任何变更的报告已被按58.120批准并执行。

(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.

（b）所有的实验数据，包括检验体系中未料到的发现已经精确的记录并确认。

(c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.

（c）未料到的可能会影响质量或研究完整性的情况当他们发生时已经被发现，并且已采取纠偏措施且已记录在案。

(d) Test systems are as specified in the protocol.

（d）检验体系符合报告。

(e) All applicable good laboratory practice regulations are followed.

（e）过程符合GLP。

(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.

（f）所有的原始数据，文件，报告，样品，和最终报告在研究期间或结束时已经归档。

[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar.23, 1979]

§ 58.35 Quality assurance unit.

58.35质量控制单元

(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods,practices, records, and controls are in conformance with the regulations in this part.

每个检验场所应该有一个质量保证单元，这个质量保证单元将监测每个研究从而来保证控制设施、设备、人员、方法、操作、记录， 并且控制符合本部分要求。

For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study.

对于任何已开始的研究，质量控制单元应该完全与研究执行和指导分开。

(b) The quality assurance unit shall:

质量保证单元应该：

(1) Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study di-

rector.

保存一个所有非临床实验室研究主计划表的复印件，检验规章应作为索引同时应包括检验系统，研究性质，研究开始的时间，每个研究当前的状态，经担保人确认，研究指导员的姓名。

(2) Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible.

保存所有与非临床实验室研究有关的报告。

(3) Inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the

检查每个非临床实验室研究以足够确保研究的完整性和在每个检查阶段保存书写的正确的签名记录，记录检查时间，检查内容，检查阶段，检查人，发现和问题，采取的纠偏行动解决的问题，任何计划再检查的日期。

study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection.

Any problems found during the course of an inspection which are likely to affect study integrity shall be brought to the attention of the study director and management immediately.

任何在检查中发现的可能会影响研究完整性的问题都应该引起研究指导员的注意并立即进行控制。

(4) Periodically submit to management and the study director written status reports on each study, noting

[43 FR 60013, Dec. 22, 1978, as amended at 52FR 33780, Sept. 4, 1987]

Subpart C—Facilities

§ 58.41 General.

Each testing facility shall be of suitable size and construction to facilitatethe proper conduct of nonclinical laboratory studies. It shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study.

58.41一般

每个检验场所应该有合适的尺寸和建筑以便于进行非临床实验室研究，应该设计好从而有隔离度以阻止任何操作和行动对研究的影响。

[52 FR 33780, Sept. 4, 1987]

§ 58.43 Animal care facilities.

(a) A testing facility shall have a sufficient number of animal rooms or areas, as needed, to assure proper:

(1) Separation of species or test systems, (2) isolation of individual projects, (3) quarantine of animals, and (4) routine or specialized housing of animals.

(b) A testing facility shall have a number of animal rooms or areas separate from those described in paragraph

(a) of this section to ensure isolation of studies being done with test systems or test and control articles known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.

(c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory animal diseases. These areas shall provide effective isolation for the housing of animals either known or suspected of being diseased, or of being carriers of disease, from other animals.

(d) When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]

§ 58.45 Animal supply facilities.

There shall be storage areas, as needed, for feed, bedding, supplies, and equipment. Storage areas for feed and bedding shall be separated from areas housing the test systems and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means. [43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]

§ 58.47 Facilities for handling test and control articles.

58.47用于检验和控制单元的设施。

(a) As necessary to prevent contamination or mixups, there shall be separate areas for:

作为必要的预防污染措施，以下区域应是单独隔离：

(1) Receipt and storage of the test and control articles.

接收和储存检验和控制单元。

(2) Mixing of the test and control articles with a carrier, e.g., feed.

用运输工具混合检验和控制单元，例如种子。

(3) Storage of the test and control article mixtures.

储存检验和控制单元混合物。

(b) Storage areas for the test and/orcontrol article and test and controlmixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity,strength, purity, and stability of the articles and mixtures.

检验和/控制单元的储存区域和检验、控制单元应该与检验系统分开，并应该有足够的措施保护单元和混合物的鉴别、含量、纯度和稳定性

§ 58.49 Laboratory operation areas.

化验室操作区域

Separate laboratory space shall be provided, as needed, for the performance of the routine and

应提供单独的实验室空间，如果需要，对于执行非临床化验室研究需要的规律的确定的程序。

specialized procedures required by nonclinical laboratory studies.

[52 FR 33780, Sept. 4, 1987]

§ 58.51 Specimen and data storage facilities.

58.51样品和数据存储设施

Space shall be provided for archives,limited to access by authorized personnel only,

应该提供档案储存空间，对于储存和检索所有原始数据和样品的空间限制只允许授权人员进出。

for the storage and retrieval of all raw data and specimens from completed studies.

Subpart D—Equipment

D部分—设备

§ 58.61 Equipment design.

58.61设备设计

Equipment used in the generation,measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol and shall be suitably located for operation,inspection, cleaning, and maintenance.

测试用的设备，或者评估数据和用于环境控制的设备应该被合适的设计并有足够的能力按照报告操作。应被合适的放置以便于进行检查、清洁和维护。

[52 FR 33780, Sept. 4, 1987]

§ 58.63 Maintenance and calibration of equipment.

58.63设备的维护和校验

(a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated and/or standardized.

设备应当被足够检查、清洁和维护。用于测试或评估数据的设备应当被足够测试，校验和标准化。

(b) The written standard operating procedures required under § 58.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment,

按照58.81（b）（11）要求的标准操作规程应该有足够的细节在方法，原料，和要执行的规律性的检查计划，清洁，维护，检验，校验，和/或设备标准化。

and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment.

并且应该详述，如果适用，当设备出现故障或失败时的补救措施。

The written standard operating procedures shall designate the person responsible for the performance of each operation.

标准操作规程应该规定好每个操作中每个人的职责。

(c) Written records shall be maintained of all inspection, maintenance, testing, calibrating and/or standardizing operations.

所有的检查、维护、检验、校验和/或标准化操作的书写记录应该被保存。

These records, containing the date of the operation, shall describe whether the maintenance operations were routine and followed the written standard operating procedures.

包括操作日期的这些记录，，应该描述这些维护操作是否是正常的是否按照SOP进行。

Written records shall be kept of nonroutine repairs performed on equipment as a result of failure and malfunction.

当出现失败结果或设备故障时的非正常的设备维修记录应保存。

Such records shall document the nature of the defect, how and when the defect was discovered, and any remedial action taken in response to the defect.

这些非正常的维修记录应该记录过失的类型，何时和怎样发现的这些过失，针对这些过失采取的补救行动。

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4,

2002]

Subpart E—Testing Facilities Operation

E部分——检验设施操作

§ 58.81 Standard operating procedures.

58.81 SOP

(a) A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study.

一个检验场所应该有足够保证研究质量和数据完整性的SOP。

All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data.

所有的偏离SOP的偏差都应被研究指导员批准并将原始数据文件化。

Significant changes in established standard operating procedures shall be properly authorized in writing by management.

SOP显著的变更应被管理人员以书面程序按正确批准。

(b) Standard operating procedures shall be established for, but not limited to, the following:

SOP应该被建立但不仅限于以下：

(1) Animal room preparation.

动物房准备

(2) Animal care.

动物饲养。

(3) Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles.

接收，确认，储存，处理，混合，和取样的方法。

(4) Test system observations.

检验系统发现。

(5) Laboratory tests.

实验室实验。

(6) Handling of animals found moribund or dead during study.

(7) Necropsy of animals or post-mortem examination of animals.

(8) Collection and identification of specimens.

样品的收集和鉴别。

(9) Histopathology

(10) Data handling, storage, and retrieval.

数据处理、储存和检索（恢复）

(11) Maintenance and calibration of equipment.

设备的维护保养和校验。

(12) Transfer, proper placement, and identification of animals.

(c) Each laboratory area shall have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Published literature may be used as a supplement to standard operating procedures.

每个实验室应有与实验室操作程序有关的实验室指南和SOP。出版物可以作为SOP的补充。

(d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.

SOP的历史版本和其他的修订本包括修订日期应该被保存。

[43 FR 60013, Dec. 22, 1978, as amended at 52FR 33780, Sept. 4, 1987]

§ 58.83 Reagents and solutions.

58.83试剂和溶液

All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date.

所有化验室的试剂和溶液应该贴签标明名称、浓度、储存要求和效期。

Deteriorated or outdated reagents and solutions shall not be used.

变质的或失效的试剂和溶液不应再用。

§ 58.90 Animal care.

(a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals.

(b) All newly received animals from outside sources shall be isolated and their health status shall be evaluated in accordance with acceptable veterinary medical practice.

(c) At the initiation of a nonclinical laboratory study, animals shall be free of any disease or condition that might interfere with the purpose or conduct of the study. If, during the course of the study, the animals contract such a disease or condition, the diseased animals shall be isolated, if necessary. These animals may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorizations of treatment, description of treatment, and each date of treatment shall be documented and shall be retained.

(d) Warm-blooded animals, excluding suckling rodents, used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require the animals to be removed from and re-turned to their home cages for any reason (e.g., cage cleaning, treatment, etc.), shall receive appropriate identification. All information needed to specifically identify each animal within an animal-housing unit shall appear on the outside of that unit.

(e) Animals of different species shall be housed in separate rooms when necessary. Animals of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to control or test articles or animal mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification shall be made.

(f) Animal cages, racks and accessory equipment shall be cleaned and sanitized at appropriate intervals.

(g) Feed and water used for the animals shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed or water are not present at levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data.

(h) Bedding used in animal cages or pens shall not interfere with the pur-pose or conduct of the study and shall be changed as often as necessary to keep the animals dry and clean.

(i) If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 54 FR 15924, Apr. 20,

1989; 56 FR 32088, July 15, 1991; 67 FR 9585,

Mar. 4, 2002]

Subpart F—Test and Control Articles

F部分——检验和控制单元

§ 58.105 Test and control article characterization.

58.105检验和控制单元特征

(a) The identity, strength, purity, and composition or other characteristics which will appropriately define the test or control article shall be determined for each batch and shall be documented.

决定每一批鉴别、含量、纯度和构成或其他的特性的界定实验和控制单元并应当文件化。

Methods of synthesis, fabrication, or derivation of the test and control articles shall be documented by the sponsor or the testing facility.

检验和控制单元的方法的合成，构建或发展应该文件化，应经担保人或检验场所批准。

In those cases where marketed products are used as control articles, such products will be characterized by their labeling.

当用于销售的药品用于控制单元时，这些药品应该用标签标明。

(b) The stability of each test or control article shall be determined by the testing facility or by the sponsor either:

每个检验或控制单元方法的稳定性应该被检验场所或担保人批准，

(1) Before study initiation, or (2) concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.

研究开始前或同时根据提供每批阶段性分析的SOP。

(c) Each storage container for a test or control article shall be labeled by name, chemical abstract number or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test or control article. Storage containers shall be assigned to a particular test article for the duration of the study.

每个用于检验或控制的储存包装应该贴签，包括名称，化学简略码或代码，批号，效期，如果适用，保持纯度、含量的必要的储存条件，和检验或控制单元的构成。储存包装形式应该被用来进行一个特殊的用来进行周期研究的检验单元。

(d) For studies of more than 4 weeks’ duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by § 58.195.

对于超过4周周期的研究，用于进行检验和控制单元的来自于每批的留样应该按照58.195的要求的时间保存。

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,

2002]

§ 58.107 Test and control article handling.

58.107检验和控制单元处理

Procedures shall be established for a system for the handling of the test and control articles to ensure that:

应该建立如何处理检验和控制单元的程序体系以确保以下：

(a) There is proper storage.

有合适的储存。

(b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.

设计的分发方式应当能防止交叉污染、退化或破坏的可能。

(c) Proper identification is maintained throughout the distribution process.

在整个的分发过程中保持适当的确认。

(d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.

每一批的接收和发放应记录在案，这些记录应包括返回或发放每一批的日期和数量。

§ 58.113 Mixtures of articles with carriers.

58.113用运输工具混合单元

(a) For each test or control article that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:

对于每一个用工具混合的检验和控制单元，检验应用合适的分析方法。

(1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test or control article in the mixture.

确定混合物的均一性并阶段性的确定混合物中检验和控制单元的浓度。

(2) To determine the stability of the test and control articles in the mixture as required by the conditions of the study either:

确定符合研究条件的混合物的检验和控制单元的稳定性，同时也在研究开始前和附随地根据SOP。

(i) Before study initiation, or (ii) Concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture.

(b) [Reserved]

(c) Where any of the components of the test or control article carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown.

当检验和控制单元混合物的每一个组分都有效期时，包装上应该清楚的标明，如果1个以上组分都有效期，应该以最早的日期为准。

[43 FR 60013, Dec. 22, 1978, as amended at 45 FR 24865, Apr. 11, 1980; 52 FR 33781, Sept. 4,

1987]

Subpart G—Protocol for and Conduct of a Nonclinical Laboratory Study

§ 58.120 Protocol.

(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following information:

(1) A descriptive title and statement of the purpose of the study.

(2) Identification of the test and control articles by name, chemical abstract number, or code number.

(3) The name of the sponsor and the name and address of the testing facility at which the study is being conducted.

(4) The number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.

(5) The procedure for identification of the test system.

(6) A description of the experimental design, including the methods for the control of bias.

(7) A description and/or identification of the diet used in the study as well as solvents, emulsifiers, and/or other materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description shall include specifications for acceptablelevels of contaminants that are reasonably expected to be present in the die tary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.

(8) Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units, othe test or control article to be administered and the method and frequency of administration.

(9) The type and frequency of tests analyses, and measurements to be made.

(10) The records to be maintained.

(11) The date of approval of the protocol by the sponsor and the dated signature of the study director.

(12) A statement of the proposed statistical methods to be used.

(b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the protocol.

[43 FR 60013, Dec. 22, 1978, as amended at 5FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4

2002]

§ 58.130 Conduct of a nonclinical laboratory study.

(a) The nonclinical laboratory study shall be conducted in accordance with the protocol.

(b) The test systems shall be monitored in conformity with the protocol.

(c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.

(d) Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that specimen histopathologically.

(e) All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data. Any change in entriesshall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,

2002]

Subparts H–I [Reserved]

Subpart J—Records and Reports

§ 58.185 Reporting of nonclinical laboratory study results.

(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following:

(1) Name and address of the facility performing the study and the dates on which the study was initiated and completed.

(2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol.

(3) Statistical methods employed for analyzing the data.

(4) The test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics.

(5) Stability of the test and control articles under the conditions of adminstration.

(6) A description of the methods used.

(7) A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.

(8) A description of the dosage, dosage regimen, route of administration, and duration.

(9) A description of all cirmcumstances that may have afected the quality or integrity of the data. (10) The name of the study director, the names of other scientists or professionals, and the names of all supervisory personnel, involved in the study.

(11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.

(12) The signed and dated reports of each of the individual scientists or other professionals involved in the study.

(13) The locations where all specimens, raw data, and the final report are to be stored.

(14) The statement prepared and signed by the quality assurance unit as described in § 58.35(b)(7).

(b) The final report shall be signed and dated by the study director.

(c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987]

§ 58.190 Storage and retrieval of records and data.

58.190保存和检索记录和数据

(a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimensof blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained.

所有的原始数据，文件，报告，最终报告，样品（除了诱变性试验样品，血液样品，尿液样品，排泄物样品和去其他液体生物样品）

(b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports.

应该有保存有序的并且能够应急恢复原始数据，文件，方案，样品和临时、最终报告的档案馆。

Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens.

保存条件应降低文件或样品的退化，使其能够在符合其保存期限要求的条件和状态下保存。

A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained else where provided that the archives have specific reference to those other locations

检验场所可能会通过商业档案馆保存所有的材料，原始数据和样品可能会在其他的能够提供特定标准的档案馆保存。

(c) An individual shall be identifiedas responsible for the archives.

独立的个体档案馆应被确认。

(d) Only authorized personnel shal enter the archives.

只有被允许的人才能进入档案室。

(e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval.

档案室内的材料应该有个索引以使应急的数据恢复能为可能。

[43 FR 60013, Dec. 22, 1978, as amended at 5FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4

2002]

§ 58.195 Retention of records.

58.195记录保存

(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter.

本节中提到的记录保存要求并不是要取代本章其他的记录保存要求。

(b) Except as provided in paragraph(c) of this section, documentation records, raw data and specimens pertaining to a nonclinical laboratory study and required to be made by this part shall be retained in the archive(s)for whichever of the following period is shortest:

除了本节(c)中提到的，本部分要求的文件记录，原始数据和属于非临床实验室研究中的样品应按以下周期中的最短期限保存：

(1) A period of at least 2 years following the date on which an application for a research or marketing permit,

被FDA批准的已提交的非临床研究所支持的研究或销售允许申请后两年，

in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drug Administration.

This requirement does not apply to studies supporting investigational new drug applications (IND’s) or applications for investigational device exemptions (IDE’s), records of which shall be governed by the provisions of paragraph (b)(2) of this section.

这些要求不适用于IND’s或IDE’s的研究，涉及以上的研究应符合（b）(2).

(2) A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to the Food and Drug Administration in support of an application for a research or marketing permit.

用于支持研究和销售允许申请的非临床试验室研究资料应保存至提交给FDA后5年。

(3) In other situations (e.g., where the nonclinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued.

其他情况下（例如非临床实验室研究不在于支持研究或销售允许申请）应保存至完成研究后2年。

(c) Wet specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids), samples of test or control articles, and specially prepared material, which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. In no case shall retention be required for longer periods than those set forth in paragraphs (a) and (b) of this section.

湿样品（除了诱变试验样品和血液、尿液、排泄物和液体生物样品），检验和控制单元的样品及特殊准备的材料，如果储存过程中质量很不稳定，应该按能够符合评估要求的时限进行储存。任何情况下储存期限不应超过（a）和（b）所规定的周期。

(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by§ 58.35

主要的计划表，方案复印件，和符合58.35要求的质量保证检查记录

(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a)and (b) of this section.

应该被质量保证单元保管，能够在（a）和（b）规定的周期内容易获得。

(e) Summaries of training and experience and job descriptions required to be maintained by § 58.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraphs(a) and (b) of this section.

按照58.29(b)培训和经验和工作描述总结应该保存，可以和其他工作记录按照（a）和（b）要求的时限保存。

(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 58.63(b) and(c), shall be retained for the length of time specified in paragraph (b) of this section.

按照58.63（b）和（c）要求的设备维护保养、校验和检查记录和报告，应按照（b）要求的时限保存。

(g) Records required by this part may be retained either as original records or as true copies such as photocopies,microfilm, microfiche, or other accurate reproductions of the original records.

本部分要求的记录是原始记录或者是如影印本、微型胶卷、微型卷片或其他的准确再现原始记录的复印件。

(h) If a facility conducting nonclinical testing goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The Food and Drug Administration shall be notified in writing of such a transfer.

如果执行非临床试验的实验室停业，所有的原始数据，文件，和其他的本节提到的材料，应该传递给该研究发起人的档案室。并且应该用书面的形式通知FDA。

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 54 FR 9039, Mar. 3,

1989]

Subpart K—Disqualification of Testing Facilities

§ 58.200 Purpose.

(a) The purposes of disqualification are:

(1) To permit the exclusion from consideration of completed studies that were conducted by a testing facility which has failed to comply with the re-quirements of the good laboratory practice regulations until it can be adequately demonstrated that such noncompliance did not occur during, or did not affect the validity or acceptability of data generated by, a particular study; and

(2) To exclude from consideration all studies completed after the date of disqualification until the facility can satisfy the Commissioner that it will conduct studies in compliance with such regulations.

(b) The determination that a nonclinical laboratory study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration.

§ 58.202 Grounds for disqualification.

The Commissioner may disqualify a testing facility upon finding all of the following:

(a) The testing facility failed to comply with one or more of the regulations set forth in this part (or any other regulations regarding such facilities in this chapter);

(b) The noncompliance adversely affected the validity of the nonclinical laboratory studies; and

(c) Other lesser regulatory actions (e.g., warnings or rejection of individual studies) have not been or willprobably not be adequate to achieve compliance with the good laboratory practice regulations.

§ 58.204 Notice of and opportunity for hearing on proposed disqualification.

(a) Whenever the Commissioner has information indicating that grounds exist under § 58.202 which in his opinion justify disqualification of a testing facility, he may issue to the testing facility a written notice proposing that the facility be disqualified.

(b) A hearing on the disqualification shall be conducted in accordance with the requirements for a regulatory hearing set forth in part 16 of this chapter. § 58.206 Final order on disqualification.

(a) If the Commissioner, after the regulatory hearing, or after the time for requesting a hearing expires with-out a request being made, upon an evaulation of the administrative record of the disqualification proceeding,makes the findings required in § 58.202,he shall issue a final order disqualifying the facility. Such order shall include a statement of the basis for that determination. Upon issuing a final order, the Commissioner shall notify(with a copy of the order) the testing

facility of the action.

(b) If the Commissioner, after a regulatory hearing or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, does not make the findings required in § 58.202,he shall issue a final order terminating the disqualification proceeding. Such order shall include a statement of the basis for that determination. Upon issuing a final order the Commissioner shall notify the testing facility and provide a copy of the order.

§ 58.210 Actions upon disqualification.

(a) Once a testing facility has been disqualified, each application for a research or marketing permit, whether approved or not, containing or relying upon any nonclinical laboratory study conducted by the disqualified testing facility may be examined to determine whether such study was or would be essential to a decision. If it is determined that a study was or would be essential,

the Food and Drug Administration shall also determine whether the study is acceptable, notwithstanding the disqualification of the facility. Any study done by a testing facility before or after disqualification may be presumed to be unacceptable, and the person relying on the study may be required to establish that the study was not affected by the circumstances that led to the disqualification, e.g., by submitting validating information. If the study is then determined to be unacceptable, such data will be eliminated from consideration in support of the application; and such elimination may serve as new information justifying thetermination or withdrawal of approval of the application.

(b) No nonclinical laboratory study begun by a testing facility after the date of the facility’s disqualification shall be considered in support of any application for a research or marketing permit, unless the facility has been reinstated under § 58.219. The determination that a study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration.

[43 FR 60013, Dec. 22, 1978, as amended at 59 FR 13200, Mar. 21, 1994]

§ 58.213 Public disclosure of information regarding disqualification.

(a) Upon issuance of a final order disqualifying a testing facility under § 58.206(a), the Commissioner may notify all or any interested persons. Such notice may be given at the discretion of the Commissioner whenever he believes that such disclosure would further the public interest or would promote compliance with the good laboratory practice regulations set forth in this part. Such notice, if given, shall include a copy of the final order issued under § 58.206(a) and shall state that the disqualification constitutes a determination by the Food and Drug Administration that nonclinical laboratory studies performed by the facility will not be considered by the Food and Drug Administration in support of any application for a research or marketing permit. If such notice is sent to another Federal Government agency, the Food and Drug Administration will recommend that the agency also consider whether or not it should accept nonclinical laboratory studies performed by the testing facility. If such notice is sent to any other person, it shall state that it is given because of the relationship between the testing facility and the person being notified and

that the Food and Drug Administration is not advising or recommending that any action be taken by the person notified.

(b) A determination that a testing facility has been disqualified and the administrative record regarding such determination are disclosable to the public under part 20 of this chapter.

§ 58.215 Alternative or additional ac-tions to disqualification.

(a) Disqualification of a testing facility under this subpart is independent of, and neither in lieu of nor a precondition to, other proceedings or actions authorized by the act. The Food and Drug Administration may, at any time, institute against a testing facility and/or against the sponsor of a nonclinical laboratory study that has been submitted to the Food and Drug Administration any appropriate judicial proceedings (civil or criminal) and any other appropriate regulatory action, in addition to or in lieu of, and prior to, simultaneously with, or subsequent to, disqualification. The Food and Drug Administration may also refer the matter to another Federal, State, or local government law enforcement or regulatory agency for such action as that agency deems appropriate.

(b) The Food and Drug Administration may refuse to consider any particular nonclinical laboratory study in support of an application for a research or marketing permit, if it finds that the study was not conducted in accordance with the good laboratory practice regulations set forth in this part, without disqualifying the testing facility that conducted the study or undertaking other regulatory action.

§ 58.217 Suspension or termination of a testing facility by a sponsor.

Termination of a testing facility by a sponsor is independent of, and neither in lieu of nor a precondition to, proceedings or actions authorized by this subpart. If a sponsor terminates or suspends a testing facility from further participation in a nonclinical laboratory study that is being conducted as part of any application for a research or marketing permit that has been submitted to any Center of the Food and Drug Administration (whether approved or not), it shall notify that Center in writing within 15 working days of the action; the notice shall include a statement of the reasons for such ac-tion. Suspension or termination of a testing facility by a sponsor does not relieve it of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration.

[43 FR FR 60013, Dec. 22, 1978, as amended at 50 FR 8995, Mar. 6, 1985]

§ 58.219 Reinstatement of a disqualified testing facility.

A testing facility that has been disqualified may be reinstated as an acceptable source of nonclinical laboratory studies to be submitted to the Food and Drug Administration if the Commissioner determines, upon an evaluation of the submission of the testing facility, that the facility can adequately assure that it will conduct future nonclinical laboratory studies in compliance with the good laboratory practice regulations set forth in this part and, if any studies are currently being conducted, that the quality and integrity of such studies have not been seriously compromised. A disqualified testing facility that wishes to be so reinstated shall present in writing to the Commissioner reasons why it believes it should be reinstated and a detailed description of the corrective actions it has taken or intends to take to assure that the acts or omissions which led to its disqualification will not recur. The Commissioner may condition reinstatement upon the testing facility being found in compliance with the good laboratory practice regulations upon an inspection. If a testing facility is reinstated, the Commissioner shallso notify the testing facility and all organizations and persons who were notified, under § 58.213 of the disqualification of the testing facility. A determination that a testing facility has been reinstated is disclosable to the public under part 20 of this chapter.

PART 60—PATENT TERM

RESTORATION

Subpart A—General Provisions

Sec.

60.1 Scope.

60.2 Purpose.

60.3 Definitions.