Introduzione
Quality by Design (QbD) is a methodology used in product development or optimization projects.
The goal of this development strategy is to obtain a holistic understanding of all potential variables which might affect the quality, efficacy, and safety of the drug product.
The biggest benefit is that quality could be designed into the product instead of purely relying on end-product testing (Quality by Testing approach).
Using such an approach requires the input and experience of a multidisciplinary team that determines the potential risk of material and process variables on product quality.
Based on this initial risk assessment, additional experimental designs could be designed and executed to further characterize the product and manufacturing process.
All the generated product and process understanding will be used to define a design space and suitable process control strategy resulting in a consistent product quality.
During this course, the QbD principle and the different steps needed for this approach will be presented in combination with examples from the field to apply and discuss from a practical point of view.
