Question: 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
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.
QbD: Lab batch (1 Kg) and Production size (100 kg) 1 o/W cream formula:1 % w/vg 80 30 Ingredients Liquid Petrolatum (heavy) Fractionated coconut oilo Crodamol OS (ethylhexyl stearate) Cetyl alcohola Span 80 (sorbitan oleate 80) Tween 80 (polysorbate 80) glycerin and butylenes glycol, mixture (equal parts) Coconut water soluble fragrance & Benzoic acido 30 20 20 20 Lab 1 Production batch 1 kg batch 100 kg 80go 8kgo 30ga 3kgo 30ga 3kg 20ga 2kgo 20ga 2kgo 20ga 2kga 50ga 3kg 0.1kgo 9ge 0.9kga 740g (mL) 74kgo 1kg / 1000go 100kgo 50 0.10 0.90 1ga Water, USP8 740 Totale 100
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