Equipment Qualification costs and time can be greatly reduced when pharmaceutical development identifies critical variability. The ISPE baseline approach to commissioning and qualification takes advantage of ICH Q8 principles. Define the CQA's and critical process parameters to drive risk-based equipment qualification.
If you follow the ISPE approach to equipment qualification, then you are aware of direct impact systems and direct impact components are qualified. The Criticality Analysis defines the process variability that directly impacts quality. It also defines what that impact is but there is more.
The Criticality Analysis defines the level of control that is necessary for a process to remain within the Proven Acceptable Range.
