June 2007 Issue
. . . or fabrum esse suae quemque fortunae  (translation: Each man the architect of his own fate)
FDA has validated risk-based approaches as best practice. The ball is back in our (manufacturers) court.
The weighroom is the entry point to manufacturing and a transition point for materials coming from the warehouse and entering process areas. Careful attention to design, layout and operation are essential.
The need for speed and access to new markets is fueling offshoring to Asia. Is a shortage of U.S. scientists and engineers also driving this trend?
Isolators have allowed Bayer Healthcares Shawnee, Kansas facility to run for three years without a single false positive.
Interest in these products is surging, but unique regulatory issues make them challenging.
Process mapping and manufacturing flexibility have significantly reduced cycle times at Genzymes Allston, Mass. facility. Paralleling the companys drive to innovate, the plant is using new technologies to improve understanding and control of its processes.
Failure to innovate in manufacturing has hurt Detroits top automakers. Theres a lesson here for Big Pharma.
The devaluation of science and engineering in the U.S. is both a cause and an effect of increased offshoring. Can and will this problem be addressed?
Balancing customer needs and business interests is critical, and "voice of the customer" exercises can be artificial. An iterative approach is necessary. This excerpt from "The Six Sigma Leader" offers some tips.
Using chemometric algorithms, modern computer technologies and rapid spectroscopic analysis, provides the basis for the modern-day development of methods of chemical analysis with the best rewards.
Expensive and fragile biologics, longer shelf-life and storage requirements and user-friendly demands are shaping the filling process.
The latest results in an ongoing survey suggest a communications gap and the need for industry to ask more questions, sooner, of FDA. They also indicate a need for better funding and staff retention within FDA.
While it may seem that pharmaceutical manufacturers are bitter enemies on the competitive battleground, it turns out that most of them have the same problems and concerns and are willing to help one another if possible. This was the message from the BIO conference session, Management of Global, Diversified Manufacturing Organizations.