Statements (44)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:drug
|
| gptkbp:alsoKnownAs |
European Union Good Manufacturing Practice guidelines
|
| gptkbp:appliesTo |
pharmaceutical manufacturers
biological medicinal products veterinary medicinal products investigational medicinal products active pharmaceutical ingredient manufacturers medicinal product manufacturers sterile medicinal products |
| gptkbp:basedOn |
Directive 2003/94/EC
Directive 91/412/EEC |
| gptkbp:compatibleWith |
EU importation of medicines
EU marketing authorization |
| gptkbp:contains |
Annexes
Part I: Basic Requirements for Medicinal Products Part II: Basic Requirements for Active Substances |
| gptkbp:enforcedBy |
gptkb:European_Union
national competent authorities |
| gptkbp:firstPublished |
1989
|
| https://www.w3.org/2000/01/rdf-schema#label |
EU GMP guidelines
|
| gptkbp:language |
English
all official EU languages |
| gptkbp:publishedBy |
gptkb:European_Parliament
|
| gptkbp:purpose |
ensure efficacy of medicinal products
ensure quality of medicinal products ensure safety of medicinal products |
| gptkbp:relatedTo |
US FDA cGMP regulations
WHO GMP guidelines |
| gptkbp:requires |
manual
risk management quality control personnel training quality management system production and process controls complaints and recalls procedures contract manufacture and analysis controls premises and equipment standards self-inspection validation and qualification |
| gptkbp:updated |
gptkb:European_Medicines_Agency
|
| gptkbp:website |
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
|
| gptkbp:bfsParent |
gptkb:current_Good_Manufacturing_Practice
gptkb:FDA_Current_Good_Manufacturing_Practice |
| gptkbp:bfsLayer |
8
|