Term
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Definition
| 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 the Public Health Service Act. |
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Term
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Definition
| 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. |
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Term
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Definition
| means the Federal Food, Drug, and Cosmetic Act, as amended |
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Term
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Definition
| means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. |
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Term
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Definition
| means a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. |
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Term
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Definition
| includes an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity. |
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Term
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Definition
| means any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study. T |
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Term
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Definition
| means any material derived from a test system for examination or analysis. |
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Term
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Definition
| 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. |
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Term
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Definition
| 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 |
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Term
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Definition
| means the individual responsible for the overall conduct of a nonclinical laboratory study |
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Term
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Definition
| means a specific quantity or lot of a test or control article that has been characterized according to Section 58.105(a) |
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Term
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Definition
| means the date the protocol is signed by the study director. |
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Term
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Definition
| means the date the final report is signed by the study director. |
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Term
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Definition
| 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 FDA |
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Term
| Applicability to studies performed under grants and contracts |
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Definition
| When a sponsor conducting a nonclinical laboratory study intended to be submitted or revieed by the FDA utilizes the services of a consulting laboratory, contractor,or grantee to perfom an analysis or other service, it shall notify the consulting laboratory, contracto, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part |
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Term
| Inspection of a testing facility |
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Definition
A testing facility shall permit an authorized employee of the FDA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect all records and specimens required to be maintained regarding studies within the scope of this part
The FDA will not consider a nonclincal laboratory study in support of an application for a research or marketing permint if the testing facility refuses to premit inspection |
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