dbo:abstract
|
- Gute Dokumentationspraxis (meist mit GDocP abgekürzt, um es von „Good Distribution Practice“, auch mit GDP abgekürzt, unterscheiden zu können) ist ein Begriff der pharmazeutischen Industrie, um die Normen, wie Dokumente erstellt und aufrechterhalten werden sollen, zu beschreiben. Zuständige Behörden sind dafür verantwortlich, Abweichungen jeglicher Form durch Anmerkungen und Beobachtungen zu beseitigen. (de)
- Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers. (en)
|
dbo:wikiPageID
| |
dbo:wikiPageLength
|
- 12840 (xsd:nonNegativeInteger)
|
dbo:wikiPageRevisionID
| |
dbo:wikiPageWikiLink
| |
dbp:date
| |
dbp:reason
|
- Cannot find this in the document; needs additional reviewer to confirm. (en)
|
dbp:wikiPageUsesTemplate
| |
dcterms:subject
| |
rdfs:comment
|
- Gute Dokumentationspraxis (meist mit GDocP abgekürzt, um es von „Good Distribution Practice“, auch mit GDP abgekürzt, unterscheiden zu können) ist ein Begriff der pharmazeutischen Industrie, um die Normen, wie Dokumente erstellt und aufrechterhalten werden sollen, zu beschreiben. Zuständige Behörden sind dafür verantwortlich, Abweichungen jeglicher Form durch Anmerkungen und Beobachtungen zu beseitigen. (de)
- Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is a (en)
|
rdfs:label
|
- Gute Dokumentationspraxis (de)
- Good documentation practice (en)
|
owl:sameAs
| |
prov:wasDerivedFrom
| |
foaf:isPrimaryTopicOf
| |
is dbo:wikiPageDisambiguates
of | |
is dbo:wikiPageRedirects
of | |
is dbo:wikiPageWikiLink
of | |
is foaf:primaryTopic
of | |