ABSTRACT
This introduction presents an overview of the key concepts discussed in the subsequent chapters of this book. The book discusses the evolution of process design and management and introduces the Artisan Model with an overview of processes over the past four millennia. It discusses the challenges relating to modern pharmaceutical manufacturing. The book looks at how pharmaceutical process design and management can be made more effective by stripping out the complexities, going back to basics and keeping it simple. It includes common tools and techniques, a review of the new paradigm' thinking from the regulators and a methodology for Process Integrated Accounting. The book explains personal distillation of proper application and the all-too-often misapplication of process design principles. The more complex business logistics has become, the further companies have strayed from the simple approaches based on fundamentals that are universally applicable to designing, controlling and otherwise managing a pharmaceutical process.
