chapter  9
10 Pages

Global Preservative Systems

ByDavid C. Steinberg

One of the most desired preservative systems is the one that can be used in global formulations, those that can be sold in all markets of the world-the idea being that one formulation will be sold everywhere. Although the concept of global preservatives sounds simple, examining which preservatives are permitted in the most difficult market (Japan) reveals that it is not as easy as one may think. Japan has the most restrictions and fewest permitted preservatives, and here, as in other countries, local attitudes also may influence which preservatives are acceptable. Further, with one exception, it is a bad idea to attempt to use one preservative system for all products. The one exception is that all production and final filling takes place at the same facility and has very strict, near sterile, current Good Manufacturing Practice (cGMP) conditions. The goal of this chapter is to review allowed concentrations and restrictions on preservatives used in two regions, the European Union (EU) and Japan, and to show how selection of preservatives that are allowed in both of these regions greatly restricts the number of preservatives that may be used in global formulas.