One area, in particular, that FDA is focusing on as a significant opportunity for advancing its quality-by-design objectives is continuous manufacturing. CDER officials’ have been highlighting their interest in continuous manufacturing at recent conferences, noting the recent progress that has been made in converting the concept into practice.
As part of a presentation on the progress being made in implementing QbD for drugs at a the IFPAC 2010 conference, CDER’s Christine Moore pointed to a diagram of a continuous tablet manufacturing process that includes fully automated testing and real-time release, which she had shown three years ago, as an example of this progress. Whereas the diagrammed continuous process seemed “rather conceptual” at that time, “I don’t think it is conceptual anymore,” she stressed, “because I have seen over those last three years several presentations by both industry and academia that are putting practically every aspect” of what the diagram depicts into practice.
At another recent conference, CDER’s Moheb Nasr also commented on how continuous manufacturing supports quality by design.
Manufacturing without interruptions with a constant flow of material in and out “fits very well within the concept of quality by design,” Nasr pointed out. “It provides an opportunity to adjust the process to meet the critical quality attributes and allows for continual monitoring and adoption of process analytical technology. It has lots of advantages. It also has some challenges.”
[Editor’s Note: The May issue of IPQ includes comments by CDER’s Moore and Nasr on continuous manufacturing as part of the issue’s in-depth analysis of the impact the new QbD paradigm is having on the initiatives and dialogue around reshaping the CMC review process.]
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