GLP Flashcards
GLP: What is the scope of GLP (21 CFR part 58)?
Good laboratory practices for conducting nonclinical lab studies that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products and electronic products.
GLP: What is the definition of a nonclinical lab study?
In vivo or in vitro experiment in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety
Does not include studies on human subjects, clinical studies, field trials in animals, basic exploratory studies
GLP: What is the definition of a sponsor?
1) 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 FDA 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
GLP: Who has overall responsibility for the technical conduct of a study, as well as for the interpretation, analysis, documentation and reporting of results?
The study director
GLP: What are the record keeping requirements for GLP studies?
All raw data, documentation, protocols, interim and final reports and specimens shall be retained for whichever of the following periods are shortest…
1) A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the FDA. Does not apply to studies supporting investigational new drug applications or applications for investigational device exemptions
2) A period of at least 5 years following the date on which the results of the nonclinical study are submitted to the FDA in support of an application for a research or marketing permit
3) A period of at least 2 years following the date of study completion, termination or discontinuation (when study does not result in an application for a permit)
