Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process / 中国药师

ABSTRACT

Objective:Through the establishment of shewhart control chart,to grasp the variation of products and avoid the occur-rence of failures.Methods:According to the characteristics and control requirements of quality parameters,several types of typical pa-rameters 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 spe-cial 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.