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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.
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.
Representatives of the US Food and Drug Administration and Industry
The following authors contributed to the article, "FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based Approach," in the May 2008 issue:
Moheb Nasr (FDA), Gerald Migliaccio (Pfizer), Barbara Allen ( Eli Lilly and Company), Robert Baum (Pfizer), Ronald Branning (Genetech), Chi-wan Chen (FDA), Joseph Famulare (FDA), Richard Friedman (FDA), Musa Ghannam (Schering-Plough), Frank Holcombe (FDA), Nirdosh Jagota (Wyeth), Christopher Joneckis (FDA), Zena Kaufman (Abbott Laboratories), Steven Kozlowski (FDA), LaiMing Lee (FDA), Anthony Lubiniecki (Centocor), Mary Malarkey (FDA), Christine Moore (FDA), Elaine Morefield (FDA), Gene Murano (Genentech), Richard Norgard (Pfizer), Helen Winkle (FDA), and Janet Woodcock (FDA).
Articles by Representatives of the US Food and Drug Administration and Industry
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