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

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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.

Pharmaceutical Technology

International harmonization. FDA's 21st Century initiatives have placed the agency in a favorable position in the emerging regulatory global environment. To fully realize the benefits of FDA's initiatives and promote the global upgrade of pharmaceutical manufacturing, careful planning and coordination of implementation will have to occur in each international region. To facilitate this, the Pharmaceutical Quality Initiatives Workshop participants suggested that:

  • Future technical workshops be held in Europe and Asia as well as in the US
  • A process validation guidance for industry be harmonized by 2009
  • Regulatory requirements and interpretations of the harmonization of quality systems be finalized in 2008
  • Collaboration to determine the right information and format for submissions that facilitate science and risk-based regulatory decision-making be completed in 2008
  • Develop a long-term ICH quality vision which ensures consistent implementation and includes drug substance be completed by the end of 2007.

Maintaining momentum. Both FDA and industry agreed at the workshop that the following should receive high priority going forward:

  • Publish a process validation guidance in 2008 that includes what process validation would look like under QbD
  • Work with generic stakeholders to develop a model example for design space
  • Determine how to achieve 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 pilot program and establish additional pilot programs for both postapproval and biotechnology to highlight successes and identify areas for improvement
  • In 2009, hold a workshop on the holistic impact of ICH Guidelines Q8, Q9, and Q10, and the pilot programs to review status, highlight successes, and identify areas for improvement.

Industry and FDA have a common purpose to make safe and effective new therapies available to patients as quickly as possible while improving quality, reducing manufacturing time, and eliminating waste. The pharmaceutical industry has long recognized the need for improvement in these areas but has lagged with buy-in for the new approaches to pharmaceutical development and manufacturing. FDA will continue to seek industry input and collaboration as it focuses on building upon the concepts explored at this workshop. The introduction of new technologies and innovations into pharmaceutical manufacturing must be guided, as always, by rigorous science. Tremendous benefits to the public, industry, and regulators are foreseen.


The authors would like to acknowledge the contributions of Diana Amador (FDA), Ferdinando Aspesi (Wyeth), Gregory Blank (Genetech), Richard Bowles, III (Schering-Plough), Susan Cady (Intervet), Monica Caphart (FDA), Barry Cherney (FDA), Gregory Claycamp (FDA), Emer Cooke (EU), Roman Drews (FDA), Eric Duffy (FDA), Douglas Ellsworth (FDA), Raafat Fahmy (FDA), Gurpreet Gill-Sangha (FDA), Brian Hasselbalch (FDA), John Hennessey (Merck), Charles P. Hoiberg (ISPE), Patricia Hughes (FDA), Robert Iser (FDA), Gordon Johnston (GPhA), Susanne Keitel (EU), Thomas Lynch (Talecris), Karen Main (AstraZeneca), Christine Mundkur (Barr Pharmaceuticals), Gordon Munro (Watson Pharmaceuticals), Joseph Phillips (ISPE), Carol Rehkopf (FDA), Edwin Rivera-Martinez (FDA), Nancy Rolli (FDA), Raymond Scherzer (GlaxoSmithKline), Susan Setterberg (FDA), Brenda Uratani (FDA), Timothy Wozniak (Eli Lilly and Company), Lawrence Yu (FDA), and Diane Zezza (Schering-Plough) for their valuable assistance by serving on the workshop planning committee and/or moderating some of the workshop breakouts. In addition, the editorial contributions of Kathleen Jordan (FDA), David Morley (FDA), and Frederick A. Golec (Wyeth) are very much appreciated.


1. J.W. Woodcock, "Pharmaceutical Quality in the 21st Century—An Integrated System Approach," presented at AAPS Workshop on Pharmaceutical Quality Assessment—A Science- and Risk-Based CMC Approach in the 21st Century (Bethesda, MD), Oct. 5, 2005.

There is no copyright in US Government work (per 17 USC 105), and the work the authors are providing is a US Government work.


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