Statistical Quality Control in Production of Infusion Solutions

A systematic quality control approach for monitoring the production of infusion solutions in a pharmaceutical plant is introduced. The main features of approach are combining modern quality control technologies with quality information system. Based on the strict quality requirements and the process flow of the production of infusion solutions, a serial suitable statistical quality control methods are selected and discussed. Thee are eight points relevant to the quality of production of infusion solutions, i.e., water processing, bottle preparing, production order, concentrated solution, diluted solution, sterilizing, lamp-inspection and packing. The control information related to them is summarized. According to practical conditions and different concrete quality objects, systematic consideration for process monitoring and quality data obtaining are analyzed. Based on a quality information system, the related control information can be accurately controlled in all aspects in order to establish a strict quality control and assurance system. A case study using several quality control tools are introduced and analyzed.