Establishing a design space can be

Establishing a design space can be done by linking the process inputs and variables to the CQAs through design of experiments (DOEs), failure modes and effects analysis (FMEA), and life cycle knowledge. A design space can be determined operationally through a combination of proven acceptable ranges derived from multivariant experiments and/or through modeling. The rationale for the inclusion of these parameters in the design space should be provided in the dossier, and in some cases it is helpful to provide a rationale as to why some parameters were excluded.