ABSTRACT
This chapter discusses the transformation of process management from the days of skilled artisans to the current situation of fragmented global manufacturers. It summarizes a generalized evolution of process management over the past 4,000 years. It considers implications of this evolution for the business enterprise, along with adaptations of technology and science. The paradigms of process design and implementation in the twenty-first-century pharmaceutical industry can gain significant insights from studying historical methods and techniques used by artisan trades in the construction of buildings and furniture. The business environment was shifting the economy from agrarian and skilled artisan to factory worker. The pharmaceutical industry is only just learning to focus on robust processes, despite the fact that the science underlying drug products is technologically advanced. The lessons applicable to today's pharmaceutical industry are: process designers must be knowledgeable in all process elements; single standards lead to consistent results; and all process elements must work in concert for optimum performance.
