FDA、EPA和OECD的GLP比较.docx

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLPDocument issued on: June 2004U.S. Department of Health and Human ServicesFood And Drug AdministrationOffice of Regulatory Affairs (ORA)Table of Contents Preface1 Scope and Authority2 Definitions3 Organization and Personnel 4 Facilities 5 Equipment6 Facility Operation7 Articles8 Protocol and Conduct9 Records and Reports10 Disqualification11 PrefacePublic CommentComments and suggestions may be submitted at any time to the Division of Compliance Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs (ORA), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Please refer to the exact title of this document when submitting comments or suggestions. For questions regarding the use or interpretation of this chart contact Chris Anders at (240) 632-6853, or e-mail Christopher.A.Additional CopiesAdditional copies are available from the Internet at: /ora/compliance_ref/bimo/fda_epa_oecd.html. Submit written requests for single copies of the guidance entitled Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP to the Division of Compliance Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs (ORA), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist the office in processing your requests.Scope and AuthorityComparison of FDA, EPA, OECD GLPScope and AuthorityTopicFDAEPAOECDScopeSec. 58.1(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 507, 510, 512-516, 518-520, 706, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.792.1 a. This part prescribes good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical fate testing. This part is intended to ensure the quality and integrity of data submitted pursuant to testing consent agreements and test rules issued under section 4 of the Toxic Substances Control Act (TSCA). b. This part applies to any study described by paragraph a. of this section which any person conducts, initiates, or supports on or after September 18, 1989. c. It is EPAs policy that all data developed under section 5 of TSCA be in accordance with provisions of this part. If data are not developed in accordance with provisions of this part, EPA will consider such data insufficient to evaluate the health and environmental effects of the chemical substances unless the submitter provides additional information demonstrating that the data are reliable and adequate. Section I(1) These Principles of Good Laboratory Practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or the environment.Non-clinical health and environmental safety studies covered by the Principles of Good Laboratory Practice include work conducted in the laboratory, in greenhouses, and in the field.Unless specifically exempted by national legislation, these Principles of Good Laboratory Practice apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.StudiesConductedUnderContracts58.10When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the servcies 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.792.10When a sponsor or other person utilizes the services of a consulting laboratory, contractor, or grantee to perform all or a part of a study to which this part applies, it shall notify the consulting laboratory, contractor, or grantee that the service is, or is part of, a study must be conducted in compliance with the provisions of this part.InspectionAuthority58.15(a) A testing facility shall permit an authorized employee of the Food and Drug Administration, at reasonalble 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 requried to be maintained regarding studies whithin the scope of this part. The records inspection and copying requirements shall not apply to quality assurance until records of findings and problems, or to actions recommended and taken.792.15(a) A testing facility shall permit an authorized employee of duly designatedrepresentative of EPA or FDA, 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 to which this part applies. The records inspection and copying requirements shall not apply to quality assurnace unit records of findings and problems, or to actions recommended and taken, except the EPA may seek production of these records in litigation of formal adjudicatory hearings.Consequencesof Refusing toPermitInspection58.15(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. The determination that a nonclinical laboratory study will 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 applicable statute or regulation to submit the results of the study to the Food and Drug Administration.792.15(b) EPA will not consider reliable for purposes of showing that a chemical substance or mixture does not present a risk of injury to health or the environment any data developed by a testing facility or sponsor that refuses to permit inspection in accordance with this part. The determination that a study will not be considered reliable does not, however, relieve the sponsor of a required test of any obligation under any applicable statute or regulation to submit the results of the study to EPA.Statement ofCompliance orNon-Compliance792.12Any person who submits to EPA a test required by a testing consent agreement or a test rule issued under section 4 of TSCA shall include in the submission a true and correct statement, signed by the sponsor and the study director, of one of the following types: a. A statement that the study was conducted in accordance with this part; or b. A statement describing in detail all differences between the practices used in the study and those required by this part; or c. A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this part. DefinitionsComparison of FDA, EPA, OECD GLPDefinitionsTopicFDAEPAOECDGoodLaboratoryPracticeSection I2.1.1. Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.NonclinicalLaboratoryStudy58.3(d) Nonclinical laboratory study means in vivo or in vitro experiments in which test articles are 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. 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.792.3Study means any experiment at one or more test sites, in which a test substance is studied in a test system under laboratory conditions or in the environment to determine or help predict its effects, metabolism, product performance (efficacy studies only as required by 40 CFR 158.640), environmental and chemical fate, persistence and residue, or other characteristics inhumans, other living organisms, or media. The term “ study” does not include basic exploratory studiescarried out to determine whether a test substance or a test method has any potential utility.Section I2.3.1. Non-clinical health and environmental safety study, henceforth referred to simply as “study”, means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities.Short-TermStudySection I2.3.2. Short-term study means a study of short duration with widely used, routine techniques.Sponsor58.3(f) Sponsor means a person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study; (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 (3) A testing facility, if it both initiates and actually conducts the study.792.3 1. A person who initiates and supports, by provision of financial or other resources, a study; 2. A person who submits a study to the EPA in support of an application for a research or marketing permit; or 3. A testing facility, if it both initiates and actually conducts the study. Section I2.2.5. Sponsor means an entity which commissions, supports and/or submits a non-clinical health and environmental safety study.Testing Facility58.3(g) Testing facility means a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. Testing facility includes any establishment required 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.792.3Testing facility means a person who actually conducts a study, i.e., actually uses the test substance in a test system. Testing facility encompasses only those operational units that are being or have been used to conduct studies.Section I2.2.1. Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study. For multi-site studies, those which are conducted at more than one site, the test facility comprises the site at which the Study Director is located and all individual test sites, which individually or collectively can be considered to be test facilities.Testing Facility ManagementSection I2.2.3. Test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to these Principles of Good Laboratory Practice.Test SiteSection I2.2.2. Test site means the location(s) at which a phase(s) of a study is conducted.Test SiteManagementSection I2.2.4. Test site management (if appointed) means the person(s) responsible for ensuring that the phase(s) of the study, for which he is responsible, are conducted according to these Principles of Good Laboratory Practice.Person58.3(h) Person means an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity.792.3Person includes an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity.QAU58.3(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.792.3Quality 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 the studies.Section I2.2.8. Quality Assurance Programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice.Study Director58.3(m) Study director means the individual responsible for the overall conduct of a nonclinical laboratory study.792.3Study director means the individual responsible for the overall conduct of a study.Section I2.2.6. Study Director means the individual responsible for the overall conduct of the nonclinical health and environmental safety study.PrincipalInvestigatorSection I2.2.7. Principal Investigator means an individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study. The Study Directors responsibility for the overall conduct of the study cannot be delegated to the Principal Investigator(s); this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable Principles of Good Laboratory Practice are followed.Study planSection I2.3.3. Study plan means a document which defines the objectives and experimental design for the conduct of the study, and includes any amendments.Study PlanAmendmentSection I2.3.4. Study plan amendment means an intended change to the study plan after the study initiation date.Study PlanDeviationSection I2.3.5. Study plan deviation means an unintended departure from the study plan after the study initiation date.SOPSection I2.2.9. Standard Operating Procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.Test System58.3(i) Test system means any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study. Test system also includes appropriate groups or components of the system not treated with the test or control articles.792.3Test system means any animal, plant, microorganism, chemical or physical matrix, including but not limited to soil or water, or subparts thereof, to which the test, control, or reference substance is administered or added for study. Test system also includes appropriate groups or components of the system not treated with the test, control, or reference substance.Section I2.3.6. Test system means any biological, chemical or physical system or a combination thereof used in a study.Specimen58(j) Specimen means any material derived from a test system for examination or analysis.792.3Specimen means any material derived from a test system for examination or analysis.Section I2.3.8. Specimen means any material derived from a test system for examination, analysis, or retention.Batch58.3(n) Batch means a specific quantity or lot of a test or control article that has been characterized according to Sec. 58.105(a).792.3Batch means a specific quantity or lot of a test, control, or reference substance that has been characterized according to Sec. 160.105(a).Section I2.4.3. Batch means a specific quantity or lot of a test item or reference item produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such.Test Article58.3(b) Test article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354- 360F of the Public Health Service Act.792.3Test substance means a substance or mixture administered or added to a test system in a study, which substance or mixture: 1. Is the subject of an application for a research or marketing permit supported by the study, or is the contemplated subject of such an application; or 2. Is an ingredient, impurity, degradation product, metabolite, or radioactive isotope of a substance described by paragraph (1) of this definition