FDA Perspectives: Understanding Challenges to Quality by Design - Pharmaceutical Technology

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FDA Perspectives: Understanding Challenges to Quality by Design
Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

Pharmaceutical Technology
Volume 35, Issue 9, pp. 60-64

Looking forward

The independent report served as an excellent assessment of QbD implementation by the pharmaceutical industry and of FDA policies and practices from industry's perspective. We were extremely encouraged to see from the report that the understanding and practice of QbD is evolving, gaining momentum, and generating passion throughout industry. As a result of the report, we have accelerated our internal drive toward the implementation and adoption of QbD and are in a better position to determine what we need to support the process for the next 5 years.

Looking back, the first 5 years of the QbD initiative were spent developing the concept of QbD. This included setting the aspiration and getting stakeholders on board—something we accomplished by initiating a number of outreach efforts; working with international regulators and industry to develop the ICH Q8, Q9, and Q10 guidelines on pharmaceutical development, risk management, and quality systems; and increasing our own internal knowledge and capability.

Looking forward, we plan to spend the next 5 years focusing on putting QbD into consistent practice, including ensuring the clarity of our vision, message, and aspirational targets and timelines; clarifying expectations and benefits of QbD within FDA and industry; and ensuring a broad codification and guidances. As such, we are working toward consistency of concepts within FDA, including: (1) ensuring that other organizations involved in supporting QbD (e.g., inspectional components) are completely aware of the principles of QbD and how they need to be applied, and (2) enhancing collaboration among the organizational components that are responsible for the overall quality of drugs. We are in the process of developing and implementing our internal quality system to ensure the quality and consistency of all CMC reviews, including the review of QbD submissions.

We believe that the implementation of QbD has been significant in advancing FDA's desired state for pharmaceutical manufacturing: "A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight" (1). We look forward to continuing to work with industry and other stakeholders to ensure this desired state is reached.

Helen N. Winkle is director of the Office of Pharmaceutical Science (OPS) at the Center for Drug Evaluation and Research (CDER) within FDA. Moheb M. Nasr, PhD,* is director of the Office of New Drug Quality Assessment in OPS, CDER, at FDA, 10903 New Hampshire Ave., Silver Spring, MD, 20993, tel. 301.796.1900,

*To whom all correspondence should be addressed.


1. J. Woodcock, "The Desired State: A Mutual Goal of Industry, Society, and the Regulators" (October 2005).


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