Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:Tourism
|
| gptkbp:abbreviation |
gptkb:Good_Automated_Manufacturing_Practice
|
| gptkbp:category |
gptkb:legislation
quality assurance pharmaceutical guidelines |
| gptkbp:developedBy |
gptkb:ISPE
|
| gptkbp:firstPublished |
1994
|
| gptkbp:focusesOn |
medical device industry
biotechnology industry pharmaceutical industry |
| gptkbp:fullName |
gptkb:Good_Automated_Manufacturing_Practice
|
| gptkbp:language |
English
|
| gptkbp:notableRelease |
gptkb:GAMP_5
2008 |
| gptkbp:purpose |
guidance for validation of automated systems
|
| gptkbp:relatedTo |
gptkb:EU_GMP_Annex_11
gptkb:FDA_21_CFR_Part_11 |
| gptkbp:usedFor |
compliance with regulatory requirements
computer system validation |
| gptkbp:bfsParent |
gptkb:Girard_Academic_Music_Program
|
| gptkbp:bfsLayer |
6
|
| https://www.w3.org/2000/01/rdf-schema#label |
GAMP
|