Quality by Design: an opportunity for the pharmaceutical industry

Quality by Design (QbD) is a strategy aimed to project quality by using chemometric tools. QbD represents a global approach that can involve each step of the pharmaceutical process and thus can be effectively applied in the pharmaceutical industry, leading to enhanced quality of pharmaceutical products. QbD framework is mainly based on risk assessment and multivariate tools. It consists of several steps including the definition of the goal, the assessment of the risks using structured tools, the evaluation of the effects of critical process parameters on critical quality attributes by applying experimental design, the identification of the design space and finally the development of a control strategy to ensure the desired process performances. The design space represents the core of QbD approach and is defined as the multidimensional region where the process provides quality outputs with selected probability. QbD includes all aspects and advantages of multivariate techniques, but it also adds a concept of probability, which allows the achievement of quality. Examples illustrating the usefulness of QbD approach in the optimization of analytical methods, pharmaceutical development and process development will be presented.