This month, Wyeth received a 483 from FDA for GMP violations at a facility in Puerto Rico. The company has faced issues with quality and compliance in the past, notably a consent decree for Prevnar manufacturing at its Pearl River, N.Y. facility, and a potential Sarbanes-Oxley "whistleblower" lawsuit alleging SOP and training issues at its facility in Sanford, North Carolina.
However, Wyeth is building a culture that emphasizes product quality, safety and operational excellence. This year, as reported previously, various teams at Wyeth won Pharmaceutical Manufacturing Team of the Year awards for improving efficiency and safety at their facilities.
Wyeth's operational leadership appears to be embracing operational excellence, adopting aspects of 5-S, lean, kaizen, six sigma and OEE, as well as EH&S, inventory management and ergonomics, selecting the tools that appear to be most effective.
The company expects this work to improve its efficiency, and enable it to take the "right the first time" approach to product quality that continues to elude so many drug manufacturers.
Safety and EH&S are an important part of the corporation's focus. In Montreal, for example, EH&S engineer Denis Laflamme and his team have brought total quality principles to bear in the facility's EH&S programs, turning that facility's safety performance around. These principles, including new approaches to ergonomics, are also being applied at Pearl River and other Wyeth facilities.
On Tuesday, May 30, I presented the Wyeth Consumer Healthcare Excellence in Operations team in Pearl River with its Pharmaceutical Manufacturing Team of the Year Gold award. The team's work has become an example for many of the company's other facilities.
A tour of the Pearl River plant revealed an unusually "visual" workplace, the result of careful application of 5-S concepts.
It was also extremely impressive to see how well-informed, articulate and enthusiastic the manufacturing floor employees are about the work they're doing and the improvements they have made so far and continue to make. (More on this, soon).
Few drug companies haven't received a 483, or stumbled on some regulatory problem, at some point in their histories, but corporate cultures can change and challenges can be met, head on, with strategy and an engaged workforce. Wyeth definitely appears to be on the right track.
-AMS
