Application of Quality by Design and innovative technologies to the production and control of pharmaceutical dosage forms

The presented project consisted in the application of Quality by Design (QbD) and its principles to the manufacturing process of bilastine tablets. The manufacturing process of bilastine tablets has already been developed and it is currently used for manufacturing of commercial product. The present work was not aimed at criticizing the previous process development; rather, it was intended to acquire an increased knowledge and understanding, in order to better control the steps of the process and to assure a constant quality of the final product. More and more often international authorities call for a change in the product design. In particular, the concept that quality should not be tested in the final product, but should be built-in can be accomplished following the QbD philosophy. During this work, innovative tools have been employed for process monitoring and quality control. In particular, the NIR technology has been widely applied as fast, simple, real time and non-destructive analysis.