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By Tony DeStefano

Tony DeStefanoWith the establishment of the Office of Pharmaceutical Quality (OPQ), the U.S. Food and Drug Administration (FDA) has established a framework to integrate review, inspection, surveillance, policy, and research to bring a comprehensive approach to quality oversight, to ensure consistent quality over the drug product lifecycle, and to encourage the development and implementation of modern manufacturing technologies and processes.

FDA notes in its FDA Pharmaceutical Quality Oversight white paper that the current approach of regulatory review of applications and inspection of facilities for current good manufacturing practices compliance has not proven adequate to prevent product recalls or drug shortages. In addition, the current system tends to lock in processes before they are optimized, resulting in many post-approval supplements, and it tends to treat all regulatory review and inspection practices equally, rather than employing a risk-based approach. FDA also lacks information about the current state of pharmaceutical quality, since it lacks a formal means of quality surveillance except through inspections.

The OPQ staffing structure is intended to address many of these issues. It puts in place a system that establishes a uniform approach to pharmaceutical quality across all manufacturing facilities and across all drug product areas including new, generic, and over-the-counter drugs. FDA plans to emphasize the use of risk-based approaches including clinically relevant specification and a risk-based surveillance inspection. To accomplish this, FDA is developing standardized forms and approaches, and broadening the use of question-based review as a mechanism to gather information, store it in a retrievable format, add to it on a routine basis, and search the database across all its submissions to better understand issues related to pharmaceutical quality. There is also the desire to help industry move forward with more advanced manufacturing processes, with the realization that manufacturers face unfamiliar risks, costs, and time demands when implementing new technologies.

The OPQ and the announced structure and initiatives are great steps in the right direction that will allow FDA to get a better handle on pharmaceutical quality and monitor it more comprehensively, more efficiently, and more closely to real time. This effort will, however, call for a much increased interaction between industry and FDA where industry reveals its processes in more depth and detail than was traditionally done. It will call for establishing a new level of trust and cooperation and a real effort by FDA to drive fear out of the process and work collaboratively with industry.

Standardization of expectations and clear guidance will be critical to success of the initiative. Organizations like American Association of Pharmaceutical Scientists (AAPS), Product Quality Research Institute (PQRI), and others can play important roles in bringing stakeholders and FDA together to discuss critical issues. The upcoming 2nd FDA/PQRI Conference on Advancing Product Quality will help set the stage for what might be, but the real hard work comes as guidances and expectations are developed collaboratively such that FDA has the information it needs to prove strong regulatory oversight and manufacturers can develop improved processes within a flexible regulatory framework.

Tony DeStefano, Ph.D., served as the 2013 AAPS president. He also serves as the chair of PQRI’s board of directors.