The ACPS’s Process Analytical Technology Subcommittee

2/4/02


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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 (?)

Author: CDER USER