A major pharmaceutical quality workshop was held February 28–March 2, 2007, to highlight the US Food and Drug Administration's pharmaceutical quality initiatives and to continue forging a common vision for a scientific risk-based regulatory process. The workshop was cosponsored by FDA, the American Association of Pharmaceutical Scientists (AAPS), and the International Society of Pharmaceutical Engineers (ISPE). The workshop provided a forum for regulated industry, other stakeholders, and the public to comment on progress made and to assess future needs and implementation challenges since the April 2003 inaugural workshop, "A Drug Quality System for the 21st Century." The program highlighted progress on FDA's pharmaceutical quality initiatives, building upon the themes from the agency's 2004 report, "Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach." Diverse representation from industry—including the areas of quality, regulatory affairs, development, and manufacturing—and review and compliance staff from FDA engaged in an open exchange of ideas during the plenary panel discussions and 10 breakout sessions conducted over the three day workshop. Implementation challenges and overall regulatory and scientific issues and concerns were identified for topics covering: product and process development, manufacturing and quality operations, good manufacturing practices (GMP), quality systems, and quality assurance.
Participants proposed the following action plan:
Background: pharmaceutical quality in the 21st century—the path ahead for discovery, development, and deliveryOn Aug. 21, 2002, FDA announced a significant new initiative: "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century: A Risk-Based Approach." This initiative set forth a plan to enhance and modernize FDA's regulations governing pharmaceutical manufacturing and product quality for human and veterinary drugs and select human biological products. The goal was to ensure that:
In April 2003, the Product Quality Research Institute (PQRI) and FDA held an inaugural workshop on "A Drug Quality System for the 21st Century." This workshop offered a rare opportunity for FDA and industry to share experiences and ideas to create a common vision for a scientific risk-based regulatory process. Topics addressed at the 2003 workshop included: a pharmaceutical inspectorate, changes without prior review, 21 CFR Part 11, manufacturing science, technical issue resolution, and risk-based CGMPs. This workshop provided the necessary forum to develop a framework to facilitate innovation, application of cutting-edge scientific and engineering knowledge, and implementation of modern quality management systems in pharmaceutical manufacturing.