Global trends, needs, issues.

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.

Validation and the human element.

Frequently the steps in the process which involve human intervention are the weak links in the process, the steps representing the highest risk. This is not due to lack of training or motivation of people, but to weaknesses in the design of the process and to the intrinsic error rate of manual operations. Quite often in validation work the human element is ignored while mechanical and technological aspects are studied in great detail. This article will include some examples about what we have learned about risk where human intervention is involved by using Failure Mode Effect Analysis (FMEA) and Process Reengineering methodologies. Furthermore, the implications for training and qualification of people in the validation context will be discussed.