current Good Manufacturing Practice
GPTKB entity
Statements (50)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:abbreviation |
gptkb:cGMP
|
| gptkbp:appliesTo |
pharmaceutical manufacturing
food manufacturing medical device manufacturing dietary supplement manufacturing biologics manufacturing cosmetics manufacturing |
| gptkbp:basisFor |
FDA inspections
|
| gptkbp:codifiedIn |
gptkb:21_CFR_Parts_210_and_211
|
| gptkbp:enforcedBy |
gptkb:United_States
|
| gptkbp:establishedBy |
FDA regulations
|
| https://www.w3.org/2000/01/rdf-schema#label |
current Good Manufacturing Practice
|
| gptkbp:purpose |
ensure product safety
ensure product quality ensure product efficacy |
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
gptkb:ISO_9001
gptkb:Good_Manufacturing_Practice gptkb:EU_GMP_guidelines gptkb:ICH_Q7 gptkb:Quality_System_Regulation |
| gptkbp:requires |
record keeping
environmental monitoring quality control sanitation audits training records personnel training change control complaint handling supplier qualification process validation stability testing batch records corrective and preventive actions equipment validation investigation of deviations labeling control material control product release procedures proper documentation |
| gptkbp:violatedBy |
gptkb:crime
product recalls injunctions import bans seizure of products warning letters |
| gptkbp:bfsParent |
gptkb:Good_Manufacturing_Practice
|
| gptkbp:bfsLayer |
7
|