Design Space

A multidimensional combination and interacton of input variables and process parameters that have been demonstrated to provide quality assurance

ICH Q8 defines design space as a multidimensional combination and interacton of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide quality assurance. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.