Table of Contents
FDA Regulation of Drug Quality: New Challenges
Regulation of Drug Quality: Current Status
Current Status of System for Ensuring Drug Quality
Current Status System for Ensuring Drug Quality, cont
Current Status System for Ensuring Drug Quality, cont
Regulation of Drug Quality: Analysis of Industry Factors
Regulation of Drug Quality: Analysis of Regulatory Role
Regulation of Drug Quality: Opportunity
11/2000 Science Board Presentation on PAT
Challenges for FDA
Major Barrier to Adoption:
Example: Content Uniformity
PPT Slide
Content Distribution for typical batch for USP testing
EXAMPLE
Consequences of 100% testing
LINKAGE BETWEEN 100% TESTING RESULT AND USP TEST
Numbers of tablets found outside range 75-125% among a batch of 1,000,000 tablets for different means, sigma’s
PPT Slide
What about Normality Assumption?
PPT Slide
PHARMACEUTICAL MANUFACTURING CASE STUDY:
PPT Slide
PHARMACEUTICAL MANUFACTURING CASE STUDY: CONTEXT
PHARMACEUTICAL MANUFACTURING CASE STUDY:
PHARMACEUTICAL MANUFACTURING CASE STUDY:
Application of PAT may reveal facts about currently acceptable products that could jeopardize the cGMP compliance status of the firm.
PAT is likely to improve our understanding of current processes - identifying “critical” process variables that should be controlled and highlighting variability that was less visible with sampling techniques.
Summary
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