Table of Contents
Emerging Science Issues in Pharmaceutical Manufacturing: Process Analytical Technologies
Outline
Emerging Regulatory Science Issue
Discussion Topic
Issue: Need for FDA to Facilitate Introduction of PAT
Ensuring High Efficiency of the US Pharmaceutical Manufacturing
A Perspective on Pharmaceutical Manufacturing
A Perspective on Pharmaceutical Manufacturing
When is the “right” time for process improvement?
Regulatory risks/uncertainty for process improvements
Current State: Dosage Forms
Current State:Pharmaceutical R&D and Manufacturing
Current State: Optimization
Current State: Material Science
Regulatory Challenge: Managing Changes
Current Quality Control Paradigm
Quality by Design? Product Development Knowledge (Public Databases or in Submissions)
An Example: Current Regulation of Powder Blending Operations
PPT Slide
Performance of a Solids Processing Units AIChE Journal 47: 107-125 (2001)
Today Trial-Error is the Norm Do SOP’s reflect established Heuristic rules?
Advantages of PAT for Blending
Non-homogeneous distribution of Magnesium stearate
Is Content Uniformity of “Critical” Excipients Such as Mg. Stearate Important?
PPT Slide
PPT Slide
Beyond Blending
“Win-Win” Opportunities
Potential to Reduce Scrap and Recalls
Industry-FDA Debates
What Should FDA Do to Facilitate Introduction of PAT?
What Should FDA do to Facilitate Introduction of PAT?
How Should FDA Facilitate PAT?
Questions for the Science Board
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