Table of Contents
FDA’s 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
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