STATISTICAL PROCESS-CONTROL FOR THE PHARMACEUTICAL-INDUSTRY

An overview of Total Quality Management and Statistical Process Control is provided with a goal of focusing on their implementation. The implementation is presented as three distinct areas. These are the philosophical and behavioral requirements, the statistical monitoring, and the statistical design. The first emphasizes the culture of problem solving and continuous improvement, the second focuses on the control charts, and the third on the Taguchi methods. After this overview, a discussion of common mistakes that occur in practice during the implementation of these methods is provided. Again, managerial mistakes are separated from the more specific technical or statistical mistakes. The paper concludes with recommendations concerning applications specific to the pharmaceutical industry.