Global trends, needs, issues.

Abstract

Worldwide, Pharmaceutical Plant Management struggles with the competing priorities of lowering costs, rising customer expectations, more demanding government regulations, and the need to reduce cycle times especially in the introduction of new products. All of this takes place in an environment of global competition, regulatory harmonization, mergers and downsizing, and employee insecurity. Employees are expected to do more with less, work with more sophisticated equipment and processes, take more personal responsibility for quality and productivity, work in teams, etc. In summary, we are talking about CHANGE, the speed of which will accelerate in the years to come. This presentation will discuss how some pharmaceutical plants are addressing these challenges. Examples will be given in the areas of validation, process reengineering, risk analysis, role of the quality function and people. It is my contention that most of the global trends today are insufficient to meet the challenges that we face. I hope that this presentation will generate some ideas on what the global trends should be.