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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Definitions

Comparison of FDA, EPA, OECD GLP Definitions
Topic FDA EPA OECD
Good
Laboratory
Practice
    Section I
2.1.1. 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.
Nonclinical
Laboratory
Study
58.3
(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.
792.3
Study 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 in
humans, other living organisms, or media. The term “ study” does not include basic exploratory studies
carried out to determine whether a test substance or a test method has any potential utility.
Section I
2.3.1. 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-Term
Study
    Section I
2.3.2. Short-term study means a study of short duration with widely used, routine techniques.
Sponsor 58.3
(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 I
2.2.5. Sponsor means an entity which commissions, supports and/or submits a non-clinical health and environmental safety study.
Testing Facility 58.3
(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.
792.3
Testing 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 I
2.2.1. 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 Management     Section I
2.2.3. 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 Site     Section I
2.2.2. Test site means the location(s) at which a phase(s) of a study is conducted.
Test Site
Management
    Section I
2.2.4. 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.
Person 58.3
(h) Person means an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity.
792.3
Person includes an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity.
 
QAU 58.3
(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.
792.3
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 the studies.
Section I
2.2.8. 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 Director 58.3
(m) Study director means the individual responsible for the overall conduct of a nonclinical laboratory study.
792.3
Study director means the individual responsible for the overall conduct of a study.
Section I
2.2.6. Study Director means the individual responsible for the overall conduct of the nonclinical health and environmental safety study.
Principal
Investigator
    Section I
2.2.7. 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 Director's 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 plan     Section I
2.3.3. Study plan means a document which defines the objectives and experimental design for the conduct of the study, and includes any amendments.
Study Plan
Amendment
    Section I
2.3.4. Study plan amendment means an intended change to the study plan after the study initiation date.
Study Plan
Deviation
    Section I
2.3.5. Study plan deviation means an unintended departure from the study plan after the study initiation date.
SOP     Section I
2.2.9. 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 System 58.3
(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.
792.3
Test 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 I
2.3.6. Test system means any biological, chemical or physical system or a combination thereof used in a study.
Specimen 58
(j) Specimen means any material derived from a test system for examination or analysis.
792.3
Specimen means any material derived from a test system for examination or analysis.
Section I
2.3.8. Specimen means any material derived from a test system for examination, analysis, or retention.
Batch 58.3
(n) Batch means a specific quantity or lot of a test or control article that has been characterized according to Sec. 58.105(a).
792.3
Batch means a specific quantity or lot of a test, control, or reference substance that has been characterized according to Sec. 160.105(a).
Section I
2.4.3. 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 Article 58.3
(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.
792.3
Test 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, or some other substance related to a substance described by that paragraph, which is used in the study to assist in characterizing the toxicity, metabolism, or other characteristics of a substance described by that paragraph.
Section I
2.4.1. Test item means an article that is the subject of a study.
Control Article 58.3
(c) Control article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any article other than a test article, feed, or water that is 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.
792.3
Control substance means any chemical substance or mixture, or any other material other than a test substance, feed, or water, that is administered to the test system in the course of a study for the purpose of establishing a basis for comparison with the test substance for known chemical or biological measurements.
Section I
2.4.2. Reference item ("control item") means any article used to provide a basis for comparison with the test item.
Reference
Substance
  792.3
Reference substance means any chemical substance or mixture, or analytical standard, or material other than a test substance, feed, or water, that is administered to or used in analyzing the test system in the course of a study for the purposes of establishing a basis for comparison with the test substance for known chemical or biological measurements.
Section I
2.4.2. Reference item ("control item") means any article used to provide a basis for comparison with the test item.
Carrier   792.3
Carrier means any material, including but not limited to, feed, water, soil, and nutrient media, with which the test substance is combined for administration to a test system.
 
Vehicle   792.3
Vehicle means any agent which facilitates the mixture, dispersion, or solubilization of a test substance with a carrier.
Section I
2.4.4. Vehicle means any agent which serves as a carrier used to mix, disperse, or solubilise the test item or reference item to facilitate the administration/application to the test system.
Raw Data 58.3
(k) Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, 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. 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), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.
792.3
Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. 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), the exact copy or exact transcript may be substituted for the original source as raw data. "Raw data" may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.
Section I
2.3.7. Raw data means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study. Raw data also may include, for example, photographs, microfilm or microfiche copies, computer readable media, dictated observations, recorded data from automated instruments, or any other data storage medium that has been recognised as capable of providing secure storage of information for a time period as stated in section 10, below.
Master
Schedule
    Section I
2.2.10. Master schedule means a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility.
Experimental
Starting Date
  792.3
Experimental start date means the first date the test substance is applied to the test system.
Section I
2.3.9. Experimental starting date means the date on which the first study specific data are collected.
Experimental
End Date
  792.3
Experimental end date means the last date on which data are collected directly from the study.
Section I
2.3.10. Experimental completion date means the last date on which data are collected from the study.
Study Initiation
Date
58.3
(o) Study initiation date means the date the protocol is signed by the study director.
792.3
Study initiation date means the date the protocol is signed by the study director.
Section I
2.3.11. Study initiation date means the date the Study Director signs the study plan.
Study
Completion
Date
58.3
(p) Study completion date means the date the final report is signed by the study director.
792.3
Study completion date means the date the final report is signed by the study director.
Section I
2.3.12. Study completion date means the date the Study Director signs the final report.