FDA Regulation of Drug Quality: New Challenges

5/17/02


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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

Author: CDER User