The impact of reagent standardization on the quality of diagnostic devices.

Global quality is becoming a major concern for the medical device and diagnostics industry. Good Manufacturing Practice (GMP) regulations aim to guarantee that effective and safe products are produced. However, the overall quality of a device depends on the quality of its components, which are frequently not manufactured by the manufacturer of the final product. The quality of components, such as reagents can be controlled by setting acceptance criteria, but the standardization of reagents would result in improved quality of the final product. This article briefly reviews the role of GMP regulations with regard to product quality and provides examples of how the application of modern technologies can, and in some cases has, contributed to the realization of standardizable reagents.