Table of Contents
The Process Analytical Technology (PAT) Initiative: Progress Report and Next Steps
Motivation
Why PAT?
Goals and Objectives
Strategy
Progress Report: Timeline
Collaboration: Internal
Collaboration: External
General (principles) Guidance on PAT
Options for Introducing PAT
A Sample of the ACPS PAT-Subcommittee Recommendations (02/02 Meeting)
Proposed Definition of PAT
Identify the essential or critical factors the FDA should consider in it’s effort to facilitate the introduction of PATs (topics to be covered in the proposed Guidance)
PPT Slide
PPT Slide
PPT Slide
PPT Slide
PPT Slide
Track #2: Encourage Submissions (now)
Track #2a: Encourage Established PAT Technologies
PAT Initiative:Timeline (2002)
Next Steps
Next Steps
Next Steps
Additional Information
Low efficiency..
Low Process Capability (Source: Doug Dean.PricewaterhouseCoopers. FDA Science Board Meeting November 16, 2001)
Protracted Production Cycle Times: Example (Source: G. K. Raju, M.I.T. FDA Science Board Meeting, November 16, 2001)
Protracted Production Cycle Times: Example (Source: G. K. Raju, M.I.T. FDA Science Board Meeting, November 16, 2001)
OOS or Exceptions Further Increase Cycle Times (Source: G. K. Raju, M.I.T. FDA Science Board Meeting, November 16, 2001)
Resolution of process problems slow/difficult: Tendency to “live” with the approved “validated” process (Source: G. K. Raju, M.I.T. FDA Science Board Meeting, November 16, 2001)
Low efficiency: Contributing factors
Higher Efficiencies Necessary
PROCESS ANALYTICAL TECHNOLOGIES SUBCOMMITTEE (18 participants)
PROCESS ANALYTICAL TECHNOLOGIES SUBCOMMITTEE (18 participants)
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Author: CDER USER
Home Page: http://www.fda.gov/cder/ops/default.htm
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