June 2007 Issue

Articles

  • An Argument for Change

    FDA has validated risk-based approaches as best practice. The ball is back in our (manufacturers’) court.

  • Weighing and Dispensing: Do it Right

    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.

  • Pharma's Global Hunt for Talent

    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?

  • Mapping the Way to Innovation

    Process mapping and manufacturing flexibility have significantly reduced cycle times at Genzyme’s Allston, Mass. facility. Paralleling the company’s drive to innovate, the plant is using new technologies to improve understanding and control of its processes.

  • From the Editor: Let’s Ditch Dilbert

    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?

  • A Tough Order to Fill

    Expensive and fragile biologics, longer shelf-life and storage requirements and user-friendly demands are shaping the filling process.

  • Tracking FDA’s Interaction with Industry

    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.

  • Global Concerns Discussed at BIO

    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.”