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


Q: The CMC Pilot Program breakout session recommended an end-of-Phase 2 or a mid-Phase 3 meeting between firms and FDA to discuss QbD implementation programs. Might this happen? If so, what type of preliminary information will be required from manufacturers to engage discussion about QbD implementation?

A: This is already happening. Based on FDA's experience in the past year, several sponsors have voluntarily submitted QbD-related questions for discussion in an end-of-Phase-2 meeting. The type of preliminary information needed depends on the type of questions raised by the sponsor.—Answered by Dr. Nasr

Q: The Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach initiative set out to develop "a product quality regulatory system for the future." As pointed out during the 2007 workshop, international cooperation is a guiding principle to this approach. However, given the exponential growth of pharmaceutical manufacturing abroad and the recent series of negative events tied to products made overseas, especially in China, do you feel that the initiative has enough of an international approach? In your opinion, is there more that can be done? Are there plans to extend the CMC Pilot Program globally?

A: ICH guidelines Q8, Q9, and Q10 are based on the same concepts and principles as the Pharmaceutical CGMPs for the 21st Century (i.e., a science- and risk-based approach to drug development and product life cycle management). Recognizing the importance of globally harmonized approaches to these new concepts, the ICH expert working group will convene this June to develop a plan for implementing Q8, Q9, and Q10. The outcome of that meeting will be made public as soon as possible. In addition to ICH, FDA is committed to collaborating with our international partners to facilitate the implementation of modern science and risk-based approaches to pharmaceutical development and manufacturing throughout the entire product life cycle. FDA is unaware of any plans to extend the pilot program globally.—Answered by Dr. Nasr

Q: Can you address the fifth goal that came out of the 2007 workshop for the path ahead: maintaining momentum within FDA? For example, Commissioner Andrew von Eschenbach recently gave a speech about FDA's need to "re-create" itself to meet the regulatory needs and challenges of today's food and drug market. How are FDA investigators preparing to take a new approach? How will the objectives of the these goals affect inspections?

A:All of the initiatives referenced here involve training coordination and communication between CDER and investigators. This continues to advance on a steady pace with the CMC Pilot Program involving close collaboration between review, compliance, and inspection and details of Pharmaceutical Inspectorate candidates to the Center. There will be more to come with regard to what the Commissioner reported as FDA's Office of Regulatory Affairs completes its revitalization plan and work plans are developed for FY 2009.—Answered by Mr. Famulare

*This Q&A interview took place in March 2008, one year after the Pharmaceutical Quality Initiatives Workshop.


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