국내 종합병원부설 생명공학연구소의 GMP 시설에 대한 실태조사 및 공간구성에 대한 연구

Abstract

The medicine is used for diagnosis, treatment or prevention of disease and consequently has an important influence upon human life and health. Its effectiveness and safety must be guaranteed. In order to achieve the facility that meets GMP, KFDA has provided standards for quality assurance of the manufacture, examination and tests of medical supplies.The result of this study were as follows : the GMP facilities are divided into work, lab/test and storage spaces, and the systematic corridor. The clean rooms are mainly installed in work and lab/test spaces, and maintain class 10,000 in average. The individual space for the procedures that requires class 100 is not provided as a separate division. Instead, they are performed in the clean bench of the laboratory.