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Statistical Quality Control in Production of Infusion Solutions

机译:输液生产中的统计质量控制

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摘要

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.
机译:介绍了一种用于监视制药厂中输液溶液生产的系统质量控制方法。该方法的主要特征是将现代质量控制技术与质量信息系统相结合。基于严格的质量要求和输液生产工艺流程,选择并讨论了一系列合适的统计质量控制方法。您有八个与输注液生产质量有关的点,即,水处理,制瓶,生产订单,浓缩液,稀释液,灭菌,灯检和包装。总结了与它们有关的控制信息。根据实际情况和不同的混凝土质量目标,分析了过程监控和质量数据获取的系统考虑。基于质量信息系统,可以在各个方面对相关控制信息进行精确控制,以建立严格的质量控制和保证体系。介绍并分析了使用几种质量控制工具的案例研究。

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