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Is QbD activity company-wide or occurring within smaller groups in the company?
QbD implementation started off as something that smaller groups would get involved with. However, as these concepts have matured over time, more companies are implementing it company-wide as they are realizing that the latter is necessary to realize the gains from the benefits of QbD implementation.
Can you identify geographical or company size differences in who is using QbD?
Since the early push for QbD implementation in biologics came from the U.S. FDA, major manufacturers based in North America are the furthest along in QbD implementation followed by the major manufacturers based in Europe. These are followed by the mid-size companies based in these geographies. Companies based in Japan and ROW are lagging in QbD implementation and are in varying degrees of progress.
What role is QbD playing in continuous manufacturing programs?
It could be argued that the renewed interest in continuous manufacturing was pushed by QbD implementation, in particular that of Process Analytical Technology (PAT). The key PAT concepts, namely real-time product quality-based decision making, is central to success of a continuous manufacturing program.
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