| Production as a system was used to design and establish Quality System organization in the new start up biotechnology company. In viewing drug production as a system and implementing them, the process was broken down to modules where five major sections: (1) Material, (2) People, (3) Equipment, (4) Facility and (5) Management were identified through process flow diagram.; A review of the required quality systems from the Food and Drug Administration (FDA) was performed for designing quality systems to assure compliance with regulations. In assuring that the common language of statistics was applied, a metric was developed to measure the efficiency of the established system. The result of establishing quality systems focusing on "production as a system," allowed removing special causes from processes and provided proper documentation to successfully obtain pre-approval inspection from the FDA. |
