美国GLP完整版

[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。

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(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

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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

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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

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