Talking out load about validation issues

"We stay closely attuned to the FDA, the International Society for Pharmaceutical Engineering (ISPE), and other organizations," says Nancy St. Laurent, senior engineer of sterile facilities and packaging systems, Lockwood Greene. "Validation still requires an inordinate amount of time and money. There is a huge expense in materials that are wasted in some cases, and I feel way too much time is spent on some equipment that does not require extensive validation," says St. Laurent. In particular, she cites case packing, palletizing, and cartoning equipment."

Dana M. Guazzo[n], Ph.D., president, of consulting firm RxPax LLC, offers the following validation advice: "Communication between product and package development, engineering, regulatory affairs, and marketing must be constantly flowing. Outside the organization, the package development staff needs to link closely with suppliers of packaging materials and components."

John J. White, Jr., engineering project manager, Smith & Nephew Orthopedics, offers an encouraging conclusion, saying, "Validation has become more standardized now with the tools available through Six Sigma methodology such as failure mode and effects analysis, design of experiments, and process capability. These are excellent ways to predict and address potential situations prior to putting a process into production."

--By Jim Butschii, Editor