The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale.

In 2004, FDA published its final report on pharmaceutical quality for the twenty-first century, laying out a vision to modernize the regulation of pharmaceutical manufacturing and enhance product quality. As articulated by Janet Woodcock, Director of FDA CDER, the realization of this vision would result in "a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight." Since 2004, we have witnessed significant progress toward this vision; however, at the same time, CDER's mission has been confronted with new and increasingly complex challenges, such as unprecedented drug shortages and recalls, which in part reflect failures in pharmaceutical quality.

FDA is now poised, largely through the creation of the OPQ, to promote "One Quality Voice" through the integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality. OPQ will exercise concerted strategies designed to streamline regulatory processes, advance quality standards, and initiate surveillance function of quality within CDER. OPQ is charged with bringing a comprehensive approach to quality oversight to ensure consistent quality over the drug product lifecycle. To that effect, OPQ will develop mechanisms to proactively engage stakeholders and accelerate the adoption of emerging technology to enhance quality and reliability.

Conclusion:

The Office of Pharmaceutical Quality is poised to achieve the goals laid out in FDA's 21st Century Initiative. The establishment of OPQ will result in enhanced transparency and communication between the Agency and industry related to manufacturing technologies, issues, and capabilities, thereby preventing drug shortages and ensuring the availability of high-quality drugs. Additionally, OPQ will: