“Pharmaceutical GMP’s for the 21st Century”: FDA’s New Initiative on Drug Product Quality

10/29/02


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Table of Contents

“Pharmaceutical GMP’s for the 21st Century”: FDA’s New Initiative on Drug Product Quality

Agenda

Long Term Strategic Goals (GPRA): Long Term Strategic Goals (GPRA): What is this Initiative? It’s a BIG- Picture Look

Background

Background: Significant changes in pharmaceutical environment have occurred in last several decades

PPT Slide

Major Themes and Principles

Major Themes & Principles

Principle: Integrated Quality Systems Orientation

Immediate Steps (Six months)

Immediate Steps

Immediate Steps

Overall Approaches

Overall Approaches

Intermediate Step

Ongoing

What do we hope to accomplish?

What do we hope to accomplish?

Author: FDA.CDER