Good Laboratory Practice for Nonclinical Laboratory Studies
GPTKB entity
Statements (27)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:abbreviation |
gptkb:GLP
|
| gptkbp:appliesTo |
pharmaceutical development
medical device development preclinical safety studies nonclinical laboratory studies animal toxicology studies |
| gptkbp:codifiedIn |
gptkb:21_CFR_Part_58
|
| gptkbp:compatibleWith |
basic exploratory research
clinical studies in humans |
| gptkbp:enforcedBy |
gptkb:FDA
|
| https://www.w3.org/2000/01/rdf-schema#label |
Good Laboratory Practice for Nonclinical Laboratory Studies
|
| gptkbp:issuedBy |
gptkb:United_States_Food_and_Drug_Administration
|
| gptkbp:legalStatus |
federal regulation in the United States
|
| gptkbp:purpose |
ensure quality and integrity of nonclinical safety data
|
| gptkbp:relatedTo |
OECD Principles of Good Laboratory Practice
|
| gptkbp:requires |
facility management
personnel training standard operating procedures archiving of records quality assurance unit proper documentation equipment calibration and maintenance test and control article characterization |
| gptkbp:startDate |
1979
|
| gptkbp:bfsParent |
gptkb:21_CFR_Part_58
|
| gptkbp:bfsLayer |
7
|