ABSTRACT
Knowledgeable and skilled employees, capable of effective process management, are critical for successful pharmaceutical manufacturing. The five process elements man, machine, method, material and environment are tightly interwoven. Many job descriptions used in the modern pharmaceutical industry have an overly specialized and narrow scope. Job descriptions must include appropriate considerations of process roles, problem-solving responsibilities, process maintenance and documentation practices. Of the five elements, man has been the single catalyst of success in the application of innovative technology or scientific discovery to the process. However, technology is rapidly making human labour obsolete with the goal of reducing cost and improving process consistency. If the process does not work properly, there needs to be human intervention and human creativity to identify and eliminate problems, thus minimizing the business losses. In conclusion, the analysis for the man element of process design is involved with matching personnel skills to the management and maintenance needs established in the master process design.
