FDA Current Good Manufacturing Practice

URI: https://gptkb.org/entity/FDA_Current_Good_Manufacturing_Practice
GPTKB entity
Statements (36)
Predicate Object
gptkbp:instanceOf gptkb:legislation
gptkbp:abbreviation gptkb:cGMP
gptkbp:appliesTo gptkb:United_States
pharmaceutical manufacturing
food manufacturing
medical device manufacturing
biologics manufacturing
gptkbp:codifiedIn gptkb:21_CFR_Parts_210_and_211
21 CFR Part 110
21 CFR Part 820
gptkbp:enforcedBy gptkb:U.S._Food_and_Drug_Administration
gptkbp:firstIssueDate 1963
https://www.w3.org/2000/01/rdf-schema#label FDA Current Good Manufacturing Practice
gptkbp:legalBasis gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:penalty gptkb:crime
gptkb:seizure
injunction
product recall
FDA warning letter
gptkbp:purpose ensure product safety
ensure product quality
gptkbp:relatedTo gptkb:Good_Manufacturing_Practice
gptkb:EU_GMP_guidelines
gptkb:ICH_Q7
gptkbp:requires record keeping
quality control
sanitation
personnel training
complaint handling
process validation
corrective and preventive actions
equipment validation
proper documentation
gptkbp:updated multiple times
gptkbp:bfsParent gptkb:USP_Good_Manufacturing_Practices
gptkbp:bfsLayer 7