Good Manufacturing Practice (GMP) regulations

URI: https://gptkb.org/entity/Good_Manufacturing_Practice_(GMP)_regulations
GPTKB entity
Statements (32)
Predicate Object
gptkbp:instanceOf gptkb:legislation
gptkbp:alsoKnownAs cGMP (current Good Manufacturing Practice)
gptkbp:appliesTo food industry
pharmaceutical industry
medical devices industry
gptkbp:basisFor product registration
international trade requirements
gptkbp:enforcedBy gptkb:World_Health_Organization
gptkb:European_Medicines_Agency
gptkb:U.S._Food_and_Drug_Administration
regulatory agencies
gptkbp:firstIssueDate 1963
https://www.w3.org/2000/01/rdf-schema#label Good Manufacturing Practice (GMP) regulations
gptkbp:originatedIn gptkb:United_States
gptkbp:penalty gptkb:crime
fines
product recall
license suspension
gptkbp:purpose ensure product safety
ensure product quality
gptkbp:relatedTo gptkb:ISO_9001
gptkb:Hazard_Analysis_and_Critical_Control_Points_(HACCP)
gptkbp:requires record keeping
quality control
sanitation
product testing
traceability
equipment maintenance
personnel training
documented procedures
gptkbp:bfsParent gptkb:U.S._Food_and_Drug_Administration_(FDA)
gptkbp:bfsLayer 7