FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based Approach

The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.
May 02, 2008
Volume 32, Issue 5

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:

  • Publish a process validation guidance in 2008 that includes what process validation would look like under quality-by-design (QbD)
  • Work with generic stakeholders to develop a model example for design space
  • Determine how to leverage comparability protocols and QbD for short-term regulatory relief for biotech products in 2008
  • Implement scientific approaches and guidance in 2008 for more risk-based regulatory flexibility for postapproval changes and annual reports
  • Continue to share experiences from the chemistry, manufacturing, and controls (CMC) pilot program and establish additional pilot programs for both postapproval and for biotech to highlight successes and identify areas for improvement
  • Hold a workshop in 2009 on the holistic impact of Q8 pharmaceutical development, Q9 quality risk management, and Q10 quality systems, the quality guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and of the pilot programs to review status, highlight successes, and identify areas for improvement.

Background: pharmaceutical quality in the 21st century—the path ahead for discovery, development, and delivery

On 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:
  • The most up-to-date concepts of risk-management and quality systems approaches were incorporated
  • The latest scientific advances in pharmaceutical manufacturing and technology were used
  • The Chemistry, Manufacturing, and Controls (CMC) review and inspection programs operated in a coordinated and synergistic manner
  • Regulation and manufacturing standards were applied consistently
  • Management of the programs encouraged and did not impede innovation in the pharmaceutical manufacturing sector
  • Resources were used most efficiently to address the most significant health risks.

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.

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