摘要
目的:通过建立常规控制图,掌握产品质量指标的变化情况,避免不合格情况发生。方法:根据不同类型质量参数的特点及控制要求,选取几类有代表性的参数,对监测结果进行处理,绘制质量控制图,以确认生产过程是否受控。结果:通过分析控制图,可让操作人员尽快发现特殊原因导致的过程变异,并采取纠正/预防措施,确保产品持续符合既定的质量标准和工艺规程。结论:常规控制图可作为药品生产过程的监控工具,能减少不合格品率,使产品质量得到持续提升。
Objective： Through the establishment of shewhart control chart,to grasp the variation of products and avoid the occurrence of failures. Methods： According to the characteristics and control requirements of quality parameters,several types of typical parameters were introduced to illustrate the detection results and create the control charts in order to confirm whether the production was under the control. Results： The analysis of control charts could expedite the operator discovering the process variation caused by special factors,and taking corrective/preventive actions so that the products consistently complied with the regulatory specifications and production instructions. Conclusion： Control charts can be used as a monitoring tool in pharmaceutical manufacturing process,which can reduce the reject ratio and promote the continuous improvement of products.
出处
《中国药师》
CAS
2018年第2期358-362,共5页
China Pharmacist
关键词
药品生产过程
统计过程控制
常规控制图
Pharmaceutical manufacturing process
Statistical process control
Shewhart control charts
