ABSTRACT
As I look back on the trends of the late 1990s, I can make some general observations about where the industry has progressed. Barrier technology has continued to see greater implementation but has not made the dramatic impacts that were predicted. In many instances, the development of improved process technologies has negated the need for barriers, due in part to a movement away from stringent cleanroom classifications. Outsourcing has expanded as predicted. Contract manufacturing, research, and testing companies have flourished, as many small and developing companies have decided that their limited capital resources are better spent on research than on infrastructure. The industry restructuring continues today. Many big-name mergers, such as IDEC/Biogen, Glaxo/SmithKline, and Pfizer/ Pharmacia, have captured headlines worldwide. All of the famous industry prognosticators believe that the consolidation is not about to slow down soon. And the changes in the regulatory landscape continue, with new changes in the structure of the FDA, a review of GMP, and the expanded influence of more internationally focused regulatory guidance, such as the efforts of the International Committee on Harmonization (ICH) to produce standards.
