Statements (29)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:appliesTo |
active pharmaceutical ingredients
|
| gptkbp:citation |
https://www.ich.org/page/quality-guidelines
|
| gptkbp:firstPublished |
2000
|
| gptkbp:focusesOn |
Good Manufacturing Practice for Active Pharmaceutical Ingredients
|
| gptkbp:fullName |
International Council for Harmonisation Guideline Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH Q7 (GMP for APIs)
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:regulates |
gptkb:person
validation quality management materials management internal audits 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:scope |
from the initial use of starting materials through to the completion of the API
manufacture of APIs under an appropriate system for managing quality |
| gptkbp:usedBy |
pharmaceutical industry
regulatory authorities API manufacturers |
| gptkbp:bfsParent |
gptkb:ICH_Guidelines
|
| gptkbp:bfsLayer |
7
|