Potential PAT Impact Level of application
Implementation Perspective
PAT Potential Realized
Carl Anderson, DCPT, PAT Conference, Philadelphia, PA 24 March 2003 (#49)
High
Low
Driving force
Committed personnel
Required support base
R&D, Regulatory, Manufacturing, Quality
Corporate level commitment to PAT ideas
Design process and PAT together
Optimize process capabilities
Where do sensors maximize process capabilities
Apply PAT retroactively to an existing process
Optimize process capabilities
Where are sensors mitigate maximum risk
Regulatory, Manufacturing, Quality
Product team
Monitor isolated unit operations
PAT added to existing process
What can we do with on-line PAT sensors
Regulatory, Manufacturing
Department
Replace lab methods (1:1)
PAT added to existing process
What can we do with off-line PAT sensors
Regulatory, Quality
Department