GLP - CFR 21 Part 58 Flashcards
Which Act passed by Congress is referenced as part of GLPs?
Federal Food, Drug, Cosmetic Act
effective June 1979
amended 1987
Any food additive, drug, biological product, electronic product, medical device for human use, and any other material being tested is referred to in CFR 21 Part 58 as a:
a. Test Material
b. Test Article
c. Test Substance
d. Test System
b. Test Article
Field trials in animals are considered part of nonclinical laboratory studies. T or F.
False
A testing facility cannot be considered a Sponsor. T or F.
False
A testing facility can be considered a sponsor if it both initiates and conducts the study
An animal, plant, microorganism, or subpart thereof receiving the test article is called the:
a. Test Material
b. Test Article
c. Test Substance
d. Test System
d. Test System
In the event that the exact transcripts of raw data have been prepared (e.g. tapes) the exact copy or exact transcript may be substituted for the original source as raw data. T or F.
True
Photographs are not considered raw data. T or F.
False
Study Directors can be a part of the quality assurance unit. T or F.
False
The individual responsible for the overall conduct of a nonclinical laboratory study is the:
a. Study Coordinator
b. Lead Technician
c. Facility Scientific Director
d. Study Director
d. Study Director
Testing facilities may unexpectedly be inspected by which governmental agency which will look specifically at records supporting an application for a research or marketing permit.
a. USDA
b. EPA
c. FDA
d. ISO
c. FDA
A current summary of the experience, training, and job description of individuals engaged in the conduct of a nonclinical laboratory study must be documented and maintained by the testing facility. T or F.
True
Individuals with illnesses that may adversely affect the quality and integrity of nonclinical laboratory studies should be excluded from direct contact with test systems, test and control articles until the condition is corrected . T or F.
True
Study Directors have overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results. T or F.
True
The study director represents the single point of study control
Raw data is automatically given to a Sponsor at the completion of a study. T or F.
False
All raw data, documentation, protocols, and final reports are transferred to the archives during or at the close of the study
Only the Study Director, and not the quality assurance unit, shall inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study
False
Quality assurance unit reports on integrity of the study to the study director
Under the GLPs, testing facilities are required to have enough animal rooms to allow for the separation of __________ or test ____________.
species or test systems
Food and bedding storage areas need to be _______ areas housing animals.
a. Adjacent to
b. Separate from
c. Within
b. Separate from
SOP stands for what?
Standard Operating Procedure
Deviations from SOPs are to be authorized by whom?
a. The Study Director
b. The Study Sponsor
c. The Testing Facility
d. The Quality Assurance Unit
a. The Study Director
SOPs are needed for which item?
a. Animal Care
b. Animal Room Preparation
c. Handling animals found moribund or dead as well as necropsy
d. All of the Above
d. All of the Above
T/F: Space requirements for mice, rats, guinea pigs, and NHPs are specifically stated in GLP CFR 21
False
Which animals do not need identification?
a. Adult mice
b. Guinea Pigs
c. Suckling Rodents
d. Farm animals
c. Suckling Rodents
What two items need to be analyzed periodically for contaminants known to be capable of interfering with studies?
- Flooring materials
- Paint
- Feed
- Water
- Caging material
Feed & Water
Which of the following animal related items do not need to be identified in a GLP protocol?
a. Coat color
b. Body weight ranges
c. Supplier
d. Species and strain/substrain
a. Coat color
