Quality Control Laboratory Improvements

Abstract

Sanper Pharmaceutical is an inhalation anesthesia manufacturing plant. Its main products are Elim and Marile. The high demand for its products has created the need to make improvements in their processes. As part of this project, the Quality Control (QC) Laboratory Activities should be improved. Currently, the delay in laboratory analyzes hinders the Finished Drug Product release time, increasing the final release cycle’s time. Thus, it is difficult to comply with the delivery agreements made with customers. By the end of this project, QC Laboratory will minimize the analyses release time by 20% or more. This will enable the site to be more agile in the delivery of its products. To reduce the QC Laboratory Activities variability, and to align customers’ expectations, a Six Sigma methodology is appropriate. DMAIC (define-measure-analyze-improve-control) has been widely used as the method for Six Sigma implementations in Quality Control Laboratory Activities. Key Terms — DMAIC, Finished Drug Product, Quality Control Laboratory Activities, Raw Materials, Release Cycle Time Process.