Quality By Design Pilot to Reality: The Honeymoon Phase

Chantix^® was Pfizer’s first product filed using the Quality by Design approach, and was Pfizer's first product to participate in the FDA’s Pilot Program. The drug product was approved 9 months after regulatory submission on May 10, 2006.  Chantix^® is available as 0.5 and 1.0 mg immediate release tablets for the treatment of smoking cessation.  With a successful launch campaign, the product demand exceeded the original forecasts.  The Pfizer Global Manufacturing site in Illertissen, Germany was challenged to streamline processing to maximize production rates.  Through application Quality by Design and lifecycle efficiency improvements, PGM-Illertissen Right First Time team set out to do just that!  In this presentation, I will demonstrate the flexibility and benefits fostered by the QbD approach.  The manufacturing process description and metrics summarizing changes that were used to streamline the process will be contrasted to recent experience in C. Seymour’s talk entitled “Quality by Design Pilot to Reality: The Stormy Years”.