FDA's Pharmaceutical Quality for the 21st Century
A Risked Based Approach

Topics on this Page

• Introduction
• Reports
• Guidance Documents

Introduction

The Pharmaceutical Quality for the 21st Century – A Risked Based Approach is FDA’s effort to enhance and modernize the regulation of pharmaceutical manufacturing and product quality — to bring a 21st century focus to this critical FDA responsibility.  The initiative is intended to modernize FDA’s regulation of pharmaceutical quality for veterinary and human drugs and select human biological products such as vaccines.  As part of this initiative, both the pharmaceutical, as well as the chemistry, manufacturing, and controls (CMC) regulatory programs were evaluated with the following objectives in mind.  The Initiatives efforts are carried out by the Agency’s Council on Pharmaceutical Quality (CPQ)

1. Staff Manual Guide
2. CPQ Workgroups

Reports

• Initiative Report Spring 2007
• Report Fall 2004
• Second Progress Report and Implementation Plan, September 2003
• Summary Progress Report

Guidance Documents

• Pharmaceutical CGMPs for the 21st Century
• International Conference on Harmonization – Quality Guidances