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. Test site means the location(s) at which a phase(s) of a study is conducted.Ģ.2.4. 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.Ģ.2.2. 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.Ģ.2.3.
Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study. "Testing facility" encompasses only those operational units that are being or have been used to conduct studies.Ģ.2.1. 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 nonclinical laboratory studies. 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. (g) Testing facility means a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. Sponsor means an entity which commissions, supports and/or submits a non-clinical health and environmental safety study.
A person who initiates and supports, by provision of financial or other resources, a study.(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. Short-term study means a study of short duration with widely used, routine techniques. 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.Ģ.3.2. The term “ study” does not include basic exploratory studiesĬarried out to determine whether a test substance or a test method has any potential utility.Ģ.3.1. Humans, other living organisms, or media. 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 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. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. (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. 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.
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