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. 2018 Jul 25;10(3):104. doi: 10.3390/pharmaceutics10030104

Table 4.

Example of risk assessment matrix for drug nanocrystals analyzing the impact of critical material attributes (CMAs) and critical process parameters (CPPs) on product attributes: case study for drug nanocrystals. Modified from [73].

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