| 초록 |
In the late 1970s, the terminology named ‘validation' that introduced initially in 21CFR, it rose in the biggest subject in the pharmaceutical industry until now. The pharmaceutical industry which treats the life of the human being chose quality assurance to top priority subject of working for product safety and efficacy. In this point, process control system named ‘validation’ is being applied to most objective and logical tool and it is repeating continuous development and evolution. It follows many expense and time necessary to system introduction and maintenance, specially it needs professional manpower to work. Demand of the chemical engineering major capable of process analysis (theoretical and technical analysis) will increase for the purpose of technical intensive validation accomplishment. |
