Table 1.

Initial Risk Assessment (First level).

Variables	Relative Impact on CQAs		Suitable Range
	Size	Entrapment Efficiency
CMAs
Lipid Concentration	High	Medium	10 mg/mL–30 mg/mL
Drug Concentration	Medium	High	1 mg–3 mg
Lipid: Cholesterol	Low	Medium	2
CPPs
Water: Ethanol	High	Medium	3–5
Stirring speed	Medium	Low	1000 rpm
Stirring time	Low	Low	60 min