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, Moheb.Nasr@fda.hhs.gov
*To whom all correspondence should be addressed.
1. J. Woodcock, "The Desired State: A Mutual Goal of Industry, Society, and the Regulators" (October 2005).