Improving Lead Time of Sterile Drug Product Manufacturing Using Monte Carlo Simulation

Abstract

Abstract Reliable product supply is one of the most critical missions of the pharmaceutical industry. The lead time, i.e. the duration between start and end of an activity, needs to be managed in any production facility in order to make scheduling predictable' agile and flexible. We present a method for measuring and improving production lead time of pharmaceutical processes with a primary focus on Parenterals (i.e. injectables) production processes. Monte Carlo simulation (MCS) is applied for quantifying the total lead time (TLT) of a batch production as a probability distribution and sensitivity analysis reveals the ranking of sub-processes by impact on TLT. Based on these results, what-if analyses are performed to evaluate effects of investments, resource allocations and process improvements on TLT. An industrial case study was performed at a production site for Parenterals of F. Hoffmann-La Roche in Kaiseraugst, Switzerland, where the presented method supported analysis and decision-making of production enhancements.