Current Good Manufacturing Practice (cGMP)
GPTKB entity
Statements (52)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
quality standard |
| gptkbp:abbreviation |
Current Good Manufacturing Practice
|
| gptkbp:appliesTo |
biologics
cosmetics dietary supplements medical devices pharmaceutical manufacturing food manufacturing active pharmaceutical ingredients veterinary drugs finished pharmaceuticals |
| gptkbp:codifiedIn |
gptkb:21_CFR_Parts_210_and_211
|
| gptkbp:enforcedBy |
gptkb:World_Health_Organization
gptkb:FDA gptkb:European_Medicines_Agency |
| gptkbp:establishedBy |
gptkb:United_States_Code_of_Federal_Regulations
|
| gptkbp:focusesOn |
risk management
continuous improvement preventing contamination preventing deviations preventing errors preventing mix-ups |
| https://www.w3.org/2000/01/rdf-schema#label |
Current Good Manufacturing Practice (cGMP)
|
| gptkbp:penalty |
gptkb:crime
fines product recalls FDA warning letters facility shutdowns |
| gptkbp:purpose |
ensure product safety
ensure product quality ensure product efficacy |
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
gptkb:Good_Manufacturing_Practice_(GMP)
|
| gptkbp:requires |
record keeping
validation quality control sanitation calibration traceability internal audits equipment maintenance personnel training change control complaint handling supplier qualification documented procedures batch records product recall procedures |
| gptkbp:updated |
periodically
|
| gptkbp:bfsParent |
gptkb:Good_Manufacturing_Practice_(GMP)
|
| gptkbp:bfsLayer |
7
|