ABSTRACT
This chapter considers two different ways of looking at operations: Product Thinking and Process Thinking. Understanding the differences and distinctions between Product Thinking and Process Thinking is essential to proper management of drug products. Simply put, Product Thinking focuses purely on product creation. To use only product specification as the acceptance criterion is a Product Thinking point of view that exposes the company to needless process management risks. Product Thinking, the acceptance of test data by specification ranges only, undermines the theory of Process Thinking. PAT techniques drive Process Thinking approaches to overcome the legacy of arduous, multiple-lot development models. Effective process design and management requires a radical change in the thinking of traditional pharmaceutical manufacturing companies. It requires involving everyone as problem-solvers and agents of continuous improvement. The knowledge developed by a sound Process Thinking approach can be a powerful strategic tool that will facilitate continual improvement and reduce risk when technology or regulations change.
