According to the ICH harmonized guidelines, the aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls [1]. The design space is a multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality. Design space is proposed by the applicant and is subjected to regulatory assessment and approval [1].