Statements (15)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:appliesTo |
nonclinical laboratory studies
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR 58.35
|
| gptkbp:partOf |
gptkb:21_CFR_Part_58
|
| gptkbp:regulates |
gptkb:Good_Laboratory_Practice_for_Nonclinical_Laboratory_Studies
|
| gptkbp:requires |
independence of Quality Assurance Unit from study direction
establishment of a Quality Assurance Unit inspection of studies by Quality Assurance Unit maintenance of inspection records reporting of inspection results to management and study director |
| gptkbp:startDate |
1979
|
| gptkbp:title |
Quality Assurance Unit
|
| gptkbp:bfsParent |
gptkb:21_CFR_Part_58
|
| gptkbp:bfsLayer |
7
|