In the pharmaceutical and chemical industries, there is a greater need than ever to accelerate development while maintaining stringent quality standards. As development cycles shorten and product complexity increases, it has become clear that TQM ( Total Quality Management ) and QbD ( Quality by Design ), established in the 20th century, are by no means outdated methods, but rather have become indispensable in current development.
These foundations, based on statistical rigor and systematic thinking, provide the most reliable framework for accelerating development without compromising robustness. In particular, incorporating a comprehensive statistical strategy into QbD simplifies and optimizes the management of complex processes, enabling faster and more sustainable development.
This presentation will illustrate how statistical strategies contribute to development efficiency, robustness, and quality assurance, based on examples from several accelerated development programs approved since 2015 and projects to improve manufacturing processes for existing vaccines. It will also explain how JMP supports the implementation of the QbD framework in today's complex development environment.
