Lean Six Sigma for Robust Process Development

Presenter: Barry Gujral, Director, Patheon, Inc., Durham, NC, USA

Co-Presenter: Jonathan Paul Goerk, Real Time Release Process Engineer, Patheon, Durham, NC, USA

Keywords: QbD, Process, Pharmaceutical

Industry: Food/Drug/Cosmetics, Healthcare, Manufacturing

Level: Intermediate


Traditionally Lean Six Sigma is used as a structured problem-solving methodology which leads teams through a logical problem-solving approach. With six sigma, a problem with an unknown solution is analyzed though the DMAIC process to achieve higher levels of process understanding, ultimately allowing the implementation of longstanding corrective actions which improve the process control and end product quality. In addition to serving as a reactive problem-solving approach, the tools of Lean Six Sigma can be used proactively to develop robust pharmaceutical processes. The process is robust as it will be capable of consistently producing final product within specifications, by maintaining inputs within the known control limits of the critical input factors. The tools used for developing robust processes with six sigma include Design for Six Sigma, process understanding, statistical control, and design of experiments. Through the use of six sigma tools, it is possible to ultimately reach the same goals as those achieved through the use of the Quality by Design methodology.