Friedli, ThomasThomasFriedliBellm, DanielDanielBellm2023-04-132023-04-132013-10-04https://www.alexandria.unisg.ch/handle/20.500.14171/88608The history of operational excellence (OPEX) in the pharma industry is short. Since the first serious initiatives were launched at the beginning of the 21st century, OPEX gained momentum and became a priority at all hierarchies in pharma manufacturers all over the world. Simultaneously, the science of pharmaceutical manufacturing appeared on the agenda of the FDA. As a reaction to a continuously rising number of post-approval changes, the FDA started to push the industry toward developing a scientific understanding of pharmaceutical manufacturing processes and encouraged manufacturers to use innovative technologies like PAT (process analytical technology) for better process control. As a result, quality and productivity appeared on the agency's agenda, providing the industry with new opportunities and opening the way for OPEX. The incremental introduction of OPEX in the pharmaceutical industry happened in three major stages. To date, there is no clear-cut definition of the term operational excellence. In fact, the term itself is often used for newly launched improvement activities or as a proxy for cost-cutting programs, Six Sigma, and Lean initiatives, all of which contribute to its dilution over time. OPEX should be understood as the balanced management of cost, quality, and time while at the same time focusing on the customers' needs. To achieve these ends, OPEX comprises structural and behavioral changes thought to optimally support necessary activities. In order to maintain sustainability in changing or volatile environments, OPEX has to be pushed by top management and has to be designed to engage every employee. Obviously, OPEX is not only concerned with performance. It also encompasses the way leading to superior performance and to practices that allow an organization to continuously improve itself.enjournal article