Pharmaceutical cGMPs For The 21st Century — A Risk-Based Approach

In August 2002, the Food and Drug Administration (FDA or the Agency) announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century, 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, which this final report describes in detail, was 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.

• Encourage the early adoption of new technological advances by the pharmaceutical industry
• Facilitate industry application of modern quality management techniques, including implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance
• Encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas
• Ensure that regulatory review, compliance, and inspection policies are based on state-of-the- art pharmaceutical science
• Enhance the consistency and coordination of FDA's drug quality regulatory programs, in part, by further integrating enhanced quality systems approaches into the Agency's business processes and regulatory policies concerning review and inspection activities