The Evolution of Operational Excellence

The history of operational excellence (OPEX) in the pharmaceutical industry is short; the first serious OPEX initiatives were only launched about 10 years ago. Before that, the pharmaceutical industry was reluctant to put OPEX and continuous improvement on its agenda, in part because of the regulatory environment but also because it was not suffering from the same cost pressures facing other industries, such as the automotive and electronics sectors, which were forced to adopt OPEX earlier.

The discussion about a more scientific approach to pharmaceutical manufacturing only really began at a US FDA scientific advisory board meeting towards the end of 2001. The agency was facing an increasing number of post-approval manufacturing amendments at the time, making it tough to fulfill their review and inspection obligations. It became apparent that the industry did not truly understand its own manufacturing processes and that there were gaps in the science needed to gain useful knowledge. Current good manufacturing practices (cGMP) were being driven more by experience than sound science, which raised concerns, as did the overly risk-averse nature of industry and regulators.