FDAs Advisory Committee for Pharmaceutical Science The Subcommittee on Process Analytical Technologies (PAT): Overview and Objectives

2/26/02


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Table of Contents

FDAs Advisory Committee for Pharmaceutical Science The Subcommittee on Process Analytical Technologies (PAT): Overview and Objectives

Outline

What are PAT?

PAT for Pharmaceuticals: Why?

PAT for Pharmaceuticals: Why?

PAT for Pharmaceuticals: Why?

PAT for Pharmaceuticals: Why?

Risks Due to Sub-optimal Pharmaceutical Process Quality

Minimum Regulatory Sigma Level for Drugs?

Pharmaceutical OOS & Batch Failures Rates

Risks Due to Sub-optimal Pharmaceutical Process Quality

Risks Due to Sub-optimal Pharmaceutical Process Quality

Risks Due to Sub-optimal Pharmaceutical Process Quality

When?

When?

Need for FDA to Facilitate Introduction of PAT

How does FDA plan to facilitate introduction of PAT?

How does FDA plan to facilitate introduction of PAT?

How does FDA plan to facilitate introduction of PAT?: Two Tracks

General (principles) Guidance on PAT

Guidance Development Process

PPT Slide

PPT Slide

Options for Introducing PAT

PAT Subcommittee

PAT Subcommittee

Chemometrics (Kowalski and Wold)

Challenges

Author: CDER USER