Table 2.
| Control | Impact | ||
|---|---|---|---|
| Critical quality attributes (CQAs) | High | Medium | Low |
| In our Control |
Type of raw materials (oils, solid lipids, surfactants etc Concentration of lipids, surfactants Type of water/organic solvent used Amount of Water phase/ organic phase Speed of magnetic stirrer/homogenizer/sonicator Time of homogenization Method of preparation Injection speed Needle size used Temperature of the system |
Efficiency of formulator | – |
| Out of Control |
Purity of raw materials Partition coefficient of the drug Solubility profile of drug Efficiency of measurement system Environmental conditions (Room temperature, humidity, pressure etc.) |
Efficiency of Analyst, Chemist | Contamination |