Research On Quality Control And Quality Information System In Production Of Infusion Solutions

The qaulity control in the whole process of the production of infusion solutions has aroused widespread concern in recent years. And the studies of quality control approach of drug are accelerated especially under the guidance of drug standards, for example GMP standards. However the studies of quality control of the production of infusion solutions are still not perfect currently, strict quality control and assurance system based on the process flow are designed by introducing modern quality control technologies and quality information system, which is the development direction and necessary trend of infusion solutions manufacturing enterprises.This paper introduces concepts and technologies relevant to quality control of the production of infusion solutions. Problems of information acquisition and information control in the production of infusion solutions are discussed. This paper is about quality monitoring in a pharmaceutical plant that has been studied for the quality requirements and process flow of typical production of infusion solutions, which mainly analyzes the properly selecting data acquisition and statistical process control methods according to critical objectives of monitoring and data types.With applying statistical process control methods in the vital processes, quality information system can collect, analyze, and integrate quality information in the production process. And it provides a platform for information-sharing and quality improvement based on actual quality information for all functional departments and decision makers of the enterprises.This system can record perfect quality information from raw materials into the plant, to process conditions of key process parameters of production line and test of main quality parameters, and can trace to detect problems in the production process timely, which largely develops enterprise's level of production and management.