Supplementary information for the development of herbal medicine from espinheira-santa (Monteverdia ilicifolia)

The study was conducted using the principles of Quality by Design (QbD), structured in two main blocks: I. Study of analytical methodologies; II. Study of the production process. The study of analytical methodologies structured the evaluation of the responses obtained in the experimental designs, ensuring that the interpretation of the results was carried out consistently. Understanding the analytical methods employed is an essential step in establishing reliable relationships between the factors and the observed responses. The approaches to studying the production process were divided into 4 stages. Initially, process mapping and identification of the hazards involved were conducted. Then, risk assessment was carried out, followed by the planning of experiments to identify critical parameters and, finally, validation allowed the consolidation of an optimized process.