Is Your Instrumentation Qualified for Intended Use?
The USP is planning to revise their USP<1058> Analytical Instrument Qualification Chapter, August 01, 2017. The planned principal changes to USP<1058> are as follows: The revised USP chapter introduces the concept of a user-driven risk assessment to establish the level of integrated instrument qualification to demonstrate “fitness for purpose” of the instrument. In addition, the […]