Yesterday I completed my first vidcast at the AAPS Annual Meeting in Atlanta, Georgia. I had the pleasure of discussing quality by design (QbD) as it applies to analytical methods with one of the top experts in this area: Dr. Moheb Nasr, director of FDA’s Office of New Drug Quality Assessment.
One valuable point Dr. Nasr made is that there are still misconceptions about the objectives of quality by design in the industry. FDA has been working to address industry questions and concerns on what implications it will have in manufacturing and exactly what aspects may change. Specifically, they are working to address the important question of how to implement QbD principles. Dr. Nasr, who was in Brussels this past week, pointed out that the agency is working with ICH (International Conference on Harmonization) on these exact issues.
Dr. Nasr also discussed the pilot program in which Big Pharma manufacturers are already implementing QbD into their processes. This information will be a valuable part of future sessions, publications, and other educational events.
The final question concerned whether FDA planned to mandate specific analytical techniques in certain applications. Dr. Nasr emphasized that QbD is not a requirement but rather encourages industry to apply its fundamental objectives of process understanding.
My many thanks to Dr. Nasr for this opportunity. And stay tuned for additional updates from the AAPS annual meeting.
Click here to watch the vidcast at PharmTech TV.