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Impact of Quality by Design on Pharmaceutical and Analytical Development
Wednesday, November 14
9:00 am – 11:00 am
Roundtable
ACPE #073-999-07-524-L04
FDA’s initiative on Pharmaceutical cGMPs for the 21st Century is intended to encourage early adoption of new technologies through risk-based approaches by the Pharma industry. The ultimate goal is to reduce cost and cycle time, and improve efficiency. Pharmaceutical development using Quality-by-Design (QbD) methodology under Process Analytical Technology (PAT) framework is one of the ways to achieve this goal. Pharma industry is also highly interested in increasing its knowledge of manufacturing processes by using concepts of QbD and PAT. Implementation of the QbD starts from the early stage of drug development in the laboratory to gain a thorough mechanistic understanding of pharmaceutical process and key product quality attributes and define the design space. This paradigm, while not totally new, still has major impact on all areas of drug development including drug substance, drug product and analytical development. Having a clear understanding on how to implement the concepts of PAT and QbD in real world applications will be of enormous help to pharmaceutical scientists to take full advantage of this FDA initiative and develop innovative pharmaceutical processes, achieve regulatory approval and reap the purported benefits. The purpose of this roundtable is to update the audience with the status of PAT from regulator’s perspective, its global utility and the impact on all areas of drug development, regulatory filing process and post-approval change process.
Moderators
Prabu P. Nambiar, Ph.D.
Cubist Pharmaceuticals
Thirunellai Venkateshwaran, Ph.D.
Wyeth Pharmaceuticals
QbD Case Study 1: Analytical Development
Eric Ahuja, Ph.D.
Merck and Company
QbD Case Study 2: Product Development
Richard Saunders, Ph.D.
Wyeth Pharmaceuticals
Regulatory Perspectives on the Impact of QBD on Development at Various Stages
Moheb Nasr, Ph.D.
U.S. Food and Drug Administration