Production Batch: Provide final CQA risk for the critical process parameters based on QbD for the production size batch. Highlight: high risk with red, medium risk with yellow and low risk as green. Describe rationale for the risk assessment.

Liquid Petrolatum (heavy)

Fractionated coconut oil

Crodamol OS (ethylhexyl stearate)

Cetyl alcohol

Span 80 (sorbitan oleate 80)

Tween 80 (polysorbate 80)

glycerin and butylenes glycol, mixture (equal parts)

Coconut water soluble fragrance

Benzoic acid

Water, USP

(Already know highlighted color risks, need rationale). Thank you.