QbD: Convincing the Skeptics

It is human nature to resist new and different ways of thinking and working. Given past management fads, skeptics have a legitimate concern about the long-term sustainability of QbD. But the 50-plus years of its application in the major chemical companies is an assurance that it can be implemented successfully. QbD offers future benefits to companies and management willing to invest in the time and effort to be competitive. If QbD really is the competitive future, how can we learn more about it? The key industry organizations delivering education and training in the principles and tools for successful QbD implementation are the American Society for Quality, the Parenteral Drug Association, the American Association of Pharmaceutical Scientists, and the International Society for Pharmaceutical Engineering. The courses, seminars, and workshops sponsored by these organizations have demonstrated that projects using QbD approaches can be more efficient, less costly, and data rich in the development of new products. Process scientists have also learned how to mine data using these tools to improve existing products and processes. Take advantage of this opportunity. Learn more about QbD and use the tools to enhance the products delivered to patients and also improve the financial bottom line.