Table of Contents
The ACPS’s Process Analytical Technology Subcommittee
Objectives of PAT Discussion
Outline
July 19, 2001 ACPS Discussion on Optimal Applications of PAT
FDA Science Board Discussion Nov. 16, 2001
Science Board’s Response
Current Status
How Did We Get Here?
Challenges for FDA
Questions for the Science Board
Measurement Shows Potential for Improvement
Benefits - Increased Effectiveness of Compliance Infrastructure
PROCESS D WITH QC TESTS: Cycle Times including BULK ACTIVE
ON-LINE TECHNOLOGY IMPACTS DOMINANT CYCLE TIMES
LOOKING BEYOND THE “AVERAGE”
Impact of Exceptions
PAT Applications at DP Sites
The “Don’t Use” Scenario
The “Don’t Tell” Scenario
The “Win - Win” Scenario
How can we create a “Win-Win” Environment?
Shift the Manufacturing Paradigm
Issue: Need for FDA to Facilitate Introduction of PAT
“Win-Win” Opportunities
What Should FDA Do to Facilitate Introduction of PAT?
What Should FDA do to Facilitate Introduction of PAT?
How Should FDA Facilitate PAT?
A Perspective on PAT: One piece of the puzzle
Key Elements of the Emerging Program on PAT (Draft)
Types of Tests/Controls
Types of Tests/Controls (Contd.)
PPT Slide
Parametric Release & Release Tests
EMEA's Note for Guidance on Parametric Release (effective since 9/01)
Parametric Release: Dissolution?
Non-homogeneous distribution of magnesium stearate
PPT Slide
PAT FR Notice Oct. 25, 2001
Subcommittee should report on (?)
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