Objectives previously defined are the starting point of Quality by design (QbD) to ensure the quality, safety and efficacy of the product. This research was focused on the exemplifies of some QbD principles in the development of a liquid formulation from a hydroalcoholic extract of leaves of Passiflora quadrangularis, specifically those that affect the formulation proposal and the manufacturing process. In the first stage Target Product Profile, Quality Target Product Profile and Critical Quality Attributes were determined through interviews to health professionals and reviewing the scientific literature. This information guided the other process stages. In the preformulation tests, the effect of temperature, light, ethanol concentration and the effect of a polyol on response variables such as pH, color, amount of precipitate and quantification of markers was evaluated. Light was the only variable having a statistically significant effect on stability of the extract. The antimicrobial efficacy test demonstrates the self-preserved capacity of P. quadrangularis. This information will propose a prototype formulation and the corresponding manufacturing process, our risk analysis (RAM Matrix and FMEA matrix) will facilitate the design of proposals regarding control strategies.