Pharmaceutical Process Design and Management

Using their considerable knowledge and experience of pharmaceutical manufacturing, the authors take you through the various elements involved in a process: man, machine, materials, method and environment. They discuss quality control and assurance, tools for quality improvements and ways of designing the process to effectively manage outgoing quality. They believe that for processes to run successfully, all employees must be problem-solvers. With the right process design, every problem can be broken down into solvable elements. Pharmaceutical Process Design and Management shows you how to do just that.

 Introduction; Part I Evolution of Process Design and Management: Why process management is important; Artisan heritage. Part II Five Process Elements: Man: the mind of the process; Machine: the voice of the process; Method: the techniques of process control; Materials: the life-blood of the process; Environment. Part III Effective Pharmaceutical Process Design and Management: Changing the way we think; Cause and effect: getting to the root cause; Corrective action and preventive action: fixing the inevitable oops; Process-driven quality systems; Statistics and decision boundaries: data certainty; Problem-solving tools and techniques; Reducing the risk: the new paradigm; Customers; Process integrated accounting; Appendix; List of references; Index.