Subpart F - Test and Control Articles
GPTKB entity
Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulation section
|
| gptkbp:appliesTo |
nonclinical laboratory studies
GLP studies |
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:hasSection |
58.105
58.107 58.113 |
| https://www.w3.org/2000/01/rdf-schema#label |
Subpart F - Test and Control Articles
|
| gptkbp:partOf |
gptkb:21_CFR_Part_58
|
| gptkbp:purpose |
ensure integrity of test and control articles
|
| gptkbp:regulates |
handling of control articles
handling of test articles |
| gptkbp:requires |
documentation of receipt and distribution
proper identification of test and control articles retention of reserve samples storage to prevent contamination |
| gptkbp:bfsParent |
gptkb:21_CFR_Part_58
|
| gptkbp:bfsLayer |
7
|