Good Laboratory Practice (GLP)
GPTKB entity
Statements (50)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory guideline
quality system |
| gptkbp:abbreviation |
gptkb:GLP
|
| gptkbp:appliesTo |
non-clinical laboratory studies
pharmaceutical testing agrochemical testing chemical safety testing cosmetic testing |
| gptkbp:basisFor |
risk assessment
product registration regulatory submissions safety evaluation |
| gptkbp:compatibleWith |
clinical trials
manufacturing processes |
| gptkbp:countryAdopted |
gptkb:Australia
gptkb:Canada gptkb:China gptkb:European_Union gptkb:India gptkb:Japan gptkb:United_States |
| gptkbp:developedBy |
gptkb:Organisation_for_Economic_Co-operation_and_Development
|
| gptkbp:documentedIn |
gptkb:OECD_Series_on_Principles_of_Good_Laboratory_Practice_and_Compliance_Monitoring
|
| gptkbp:enforcedBy |
regulatory authorities
|
| gptkbp:establishedIn |
1970s
|
| https://www.w3.org/2000/01/rdf-schema#label |
Good Laboratory Practice (GLP)
|
| gptkbp:objective |
protect human health and environment
promote international acceptance of test data |
| gptkbp:purpose |
ensure quality and integrity of data
|
| gptkbp:regulates |
gptkb:US_Food_and_Drug_Administration
gptkb:European_Medicines_Agency gptkb:OECD_Principles_of_GLP |
| gptkbp:relatedTo |
gptkb:Good_Manufacturing_Practice
gptkb:Good_Clinical_Practice |
| gptkbp:requires |
manual
quality assurance personnel training standard operating procedures test facility organization final reports archiving of records equipment calibration study plans |
| gptkbp:scope |
toxicology studies
ecotoxicology studies analytical chemistry studies environmental fate studies physico-chemical property studies |
| gptkbp:bfsParent |
gptkb:FDA_Guidelines
|
| gptkbp:bfsLayer |
6
|