ICH Q7 Good Manufacturing Practice
GPTKB entity
Statements (30)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:alsoKnownAs |
gptkb:ICH_Q7
|
| gptkbp:appliesTo |
active pharmaceutical ingredients
|
| gptkbp:covers |
gptkb:person
validation quality management materials management change control contract manufacturers process equipment buildings and facilities complaints and recalls documentation and records laboratory controls packaging and labeling production and in-process controls |
| gptkbp:documentType |
Tourism
|
| gptkbp:focusesOn |
Good Manufacturing Practice for Active Pharmaceutical Ingredients
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH Q7 Good Manufacturing Practice
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:language |
English
|
| gptkbp:publicationYear |
2000
|
| gptkbp:referencedIn |
gptkb:US_FDA
gptkb:World_Health_Organization gptkb:European_Medicines_Agency Japanese Pharmaceuticals and Medical Devices Agency |
| gptkbp:regulates |
manufacture of active pharmaceutical ingredients
|
| gptkbp:website |
https://www.ich.org/page/quality-guidelines
|
| gptkbp:bfsParent |
gptkb:ICH
|
| gptkbp:bfsLayer |
6
|