Statements (30)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:adoptedBy |
2000
|
| gptkbp:appliesTo |
Active Pharmaceutical Ingredients
|
| gptkbp:covers |
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:focusesOn |
gptkb:Good_Manufacturing_Practice
|
| gptkbp:fullName |
ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
|
| https://www.w3.org/2000/01/rdf-schema#label |
ICH Q7
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:language |
English
|
| gptkbp:purpose |
To ensure that APIs meet quality and safety standards
|
| gptkbp:scope |
Manufacture of active pharmaceutical ingredients
|
| gptkbp:updated |
2014
|
| gptkbp:usedBy |
pharmaceutical industry
regulatory authorities |
| gptkbp:website |
https://www.ich.org/en/ich-guidelines/quality/q7-good-manufacturing-practice-active-pharmaceutical-ingredients
|
| gptkbp:bfsParent |
gptkb:ICH_Q7_Good_Manufacturing_Practice
|
| gptkbp:bfsLayer |
7
|