Table 4.
CQAs | Risk Assessment Matrix | |||||
---|---|---|---|---|---|---|
CMAs | CPPs | |||||
Surfactant Type | Surfactant Concentration | Drug Amount | Milling Time | Milling Speed | Bead Size | |
Particle size | Medium | Medium | Medium | High | High | High |
PDI | Medium | High | Medium | High | High | High |
Zeta potential | High | High | Medium | Medium | Medium | Medium |
Drug content | Low | Low | Low | low | Low | Low |
Drug release | Medium | Medium | Medium | High | High | High |