Dissolution is a critical quality parameter for oral solid dosage forms. Particularly to soft gelatin capsules (SGC), it is considered a complex process where there is involvement, not only of the API and the dissolution media, but also of the fill content and the gelatin shell. Failures on dissolution of the SGC products are frequently related to the attributes of the API and the formulation of the fill content, but they could also be due to the gelatin formulation, the interactions between the gelatin and the fill content, the process parameters during encapsulation, as well as during drying and in some cases, due to the analytical conditions. In addition, some of them occur on stability studies, at further stages of development. Formulators are aware of these issues when developing SGC. As for other products attributes, a QbD approach is useful to identify and control the critical formulation and process parameters that impact the dissolution performance.