Philadelphia, PA (July 24)—Adopting Lean Six Sigma practices in manufacturing and clinical development can help pharmaceutical companies cut costs and bring products to market faster, according to Carmen Medina, principal of Tunnell Consulting (King of Prussia, PA). Medina gave a keynote address titled “Can Lean Six Sigma Really Help?” on the opening day of the Pharmaceutical Technology Annual Conference this year^*.

The best-known ways that Lean Six Sigma aids companies, according to Medina, are by improving their yield and increasing their capacity. She detailed various other gains that the practices bring, including increased patient safety, reduced supplier variability, and enhanced business practices relating to quality assurance (QA).

Six Sigma practices are active rather than reactive, Medina said, and they therefore facilitate continuous improvement. Six Sigma changes the way companies think about their operations and sets the stage for process analysis and improvement. Medina advised that companies should take an active approach to QA. She urged companies to go beyond mere adherence to good manufacturing practices and to actively adopt lean practices for process development and manufacturing. Lean practices and Six Sigma are part of a broader approach that also includes the US Food and Drug Administration’s Process Analytical Technology and Quality by Design initiatives.

Risk assessment and management are major focuses of Lean Six Sigma, Medina noted. She underscored these topics’ importance by observing that FDA has released more guidances for risk assessment and management than for any other subject, including cleaning and validation. Because risk increases throughout the commercialization process, companies must seek continuous improvement and develop quality initiatives, Medina advised.