This document discusses Quality by Design (QbD) principles and Design of Experiments (DOE) methodology. It explains that QbD aims to design quality into products and processes through an understanding of key factors and their interactions. DOE provides a systematic approach to determine these factors and optimize conditions through carefully designed experiments. Common DOE steps include screening experiments to identify important factors, followed by optimization experiments to determine optimal levels and robustness testing to ensure consistent performance under variations.

1. Design of Experiments (DOE) G.Gallo 11 marzo 2009

8. Common steps in DOE

11. N°Experiments X1 X2 X3 1 - - - 2 2 full factorial design 2 + - - replicate experiments 3 - + - 2 3 full factorial design 4 + + - 2 3-1 fractional factorial design 5 - - + 6 + - + 7 - + + 8 + + + 9 0 0 0 10 0 0 0 11 0 0 0