Process-based Method for Reducing Product Losses in Pharmaceutical Manufacturing

Abstract We present a method for reducing product losses in sterile drug product manufacturing processes. The method consists of five steps that guides the effort of process improvement, and serves as a fundament for the Plan phase of the Plan-Do-Check-Act (PDCA) cycle. The method considers all product components of the process, e.g., Active Pharmaceutical Ingredients (APIs), excipients and primary packaging materials. In addition, a couple of mechanisms are newly developed for generating effective improvement scenarios as well as comparing effect and effort of different scenarios in a multiobjective manner. In the case study, the method was executed step-by-step using industrial data and the effectiveness of the method was demonstrated.