Good Laboratory Practice (GLP)

URI: https://gptkb.org/entity/Good_Laboratory_Practice_(GLP)

GPTKB entity

Statements (50)

Predicate	Object
gptkbp:instanceOf	gptkb:regulatory_guideline gptkb: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
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	gptkb: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
https://www.w3.org/2000/01/rdf-schema#label	Good Laboratory Practice (GLP)