Statements (27)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:abbreviation |
Good Automated Manufacturing Practice 5
|
| gptkbp:category |
gptkb:legislation
quality management |
| gptkbp:firstPublished |
2008
|
| gptkbp:focusesOn |
validation of automated systems
|
| gptkbp:fullName |
Good Automated Manufacturing Practice version 5
|
| gptkbp:guidanceSystem |
risk management
data integrity lifecycle management computer system validation |
| https://www.w3.org/2000/01/rdf-schema#label |
GAMP 5
|
| gptkbp:language |
English
|
| gptkbp:latestReleaseVersion |
2022
|
| gptkbp:publishedBy |
gptkb:International_Society_for_Pharmaceutical_Engineering
|
| gptkbp:relatedTo |
gptkb:EU_GMP_Annex_11
gptkb:FDA_21_CFR_Part_11 |
| gptkbp:targetAudience |
IT professionals
quality assurance professionals regulatory affairs specialists validation engineers |
| gptkbp:usedIn |
medical device industry
biotechnology industry pharmaceutical industry |
| gptkbp:website |
https://ispe.org/gamp-5
|
| gptkbp:bfsParent |
gptkb:GAMP
|
| gptkbp:bfsLayer |
7
|