Teva committed to QbD methodology implementation in late 2010. Inna Ben-Anat, QbD Strategy Leader, leads the implementation at Teva’s global generic R&D from Sellersville, Pennsylvania. Inna, together with Yatindra Joshi, VP Global GR&D for the US market, and Uri Hillel, Head of Quality, Global R&D, implemented the global QbD training program. This program supports R&D teams in developing QbD strategies and optimizing formulations and processes using statistical tools; assisting in the development of robust product specifications.
Ian Clegg and his Global R&D team in Sandwich U.K. have made available another video illustrating their PAT work. (Previous installments shared applications for Mid-IR and NMR spectroscopy.) The latest video shows how Near Infrared (NIR) spectroscopy can be used to monitor gases leaving a tray dryer, which can facilitate the timing of lab samples as well as cycle time reduction. Appreciation again to the folks in Sandwich.
In this videotaped interview, Allergan’s CEO David Pyott, discusses the impact of healthcare reform on the industry. Efficiency, in manufacturing, R&D and other efforts, will be key, he says. Will the need for efficiency spur interest, and corporate investment, in QbD and PAT?
At Bioprocess International’s 2009 conference, James Blackwell talked about QbD for smaller companies, and the importance of starting with the risk-management piece. Studying documented case studies from other industries can help professionals make a strong business case for QbD to senior management, he says.