Therapeutic Dose: You Can’t Cheat an Honest Man [1]
. . . or <I>fabrum esse suae quemque fortunae</I> [2] (translation: “Each man the architect of his own fate”)

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.

Minimizing Risk in Sterilization Validation
Isolators have allowed Bayer Healthcare’s Shawnee, Kansas facility to run for three years without a single false positive.

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?

Combination Products: Navigating Two FDA Quality Systems
Interest in these products is surging, but unique regulatory issues make them challenging.

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.

Big Pharma: Who's Your Role Model, Toyota or Edsel?
Failure to innovate in manufacturing has hurt Detroit’s top automakers. There’s a lesson here for Big Pharma.

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?

Know When to Listen to Your Customers...and When Not To
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.

Understanding Chemometrics for Pharmaceutical Analysis
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.

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, ...