Statements (34)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Process
|
| gptkbp:appliesTo |
healthcare
manufacturing pharmaceutical industry |
| gptkbp:basedOn |
ICH Q9 guideline
|
| gptkbp:documentedIn |
risk management plans
SOPs |
| gptkbp:goal |
gptkb:legislation
improve product quality ensure patient safety |
| https://www.w3.org/2000/01/rdf-schema#label |
Quality Risk Management
|
| gptkbp:involves |
risk communication
risk assessment risk control risk review |
| gptkbp:method |
gptkb:Fault_Tree_Analysis
gptkb:HACCP FMEA Risk Ranking and Filtering |
| gptkbp:purpose |
identify risks
assess risks communicate risks control risks review risks |
| gptkbp:regulates |
gptkb:WHO
gptkb:FDA gptkb:EMA |
| gptkbp:relatedTo |
gptkb:Good_Manufacturing_Practice
quality management system |
| gptkbp:usedBy |
manufacturers
quality assurance professionals regulatory agencies |
| gptkbp:bfsParent |
gptkb:QRM
|
| gptkbp:bfsLayer |
7
|