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
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
What about Normality Assumption?
PHARMACEUTICAL MANUFACTURING CASE STUDY:
PHARMACEUTICAL MANUFACTURING CASE STUDY: CONTEXT
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
Home Page: http://www.fda.gov/cder/ops/default.htm