| In this paper, the formulation and packaging process was analyzed and tested for solving the Domperidone Suspension assay stability problem and lower than quality specification using Process Excellence Methodology. The target is to eliminate waste, improve the production yield and productivity, avoid any man hour waste and additional quality cost.Statistical tools were used for studying the major factors of effecting Domperidone Suspension assay, the root causes were found. After detailed analysis, flow quantity control for adding water and sedimentation in pipe and buffer tank were confirmed as the critical factors. We discuss and analyze the parameters related flow meter, and analyze the mixing is an important factor related to suspension assay. A solution for flow meter accuracy improvement and a buffer tank mixer were designed.The actual result is good after upgrading the flow meter and buffer tank. The average assay of Domperidone Suspension changed from the previous 98.13% to current 98.97, and UCL and LCL also were changed from 96.48%, 99.72% to 97.87 and 99.87%. After adding on the designed mixer in buffer tank of packaging line, the Domperidone assay in first 200 bottles meet the quality specification, and the average assay changed from 95.47% to 98.63%. The target was achieved.The problem of Domperidone Suspension assay was solved very well after upgrading equipments and Standard Operation Procedure. We found the process is stable and waste was decreased after one year running. Cost saving is about 250,000RMB.The study method of Process Excellence in this paper has been used in another projects for yield improvement and productivity improvement.
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