Article: Analytical Instrument Qualification

By Wolfgang Winter

Current GxP regulations require analytical instruments to be qualified to demonstrate suitability for their intended use. Despite the fact that instrument qualification is not a new concept, and even though companies invest a lot of effort in it, related deviations are frequently cited in inspectional observations and warning letters by the US FDA and other regulatory agencies

Reprinted with permission from BioProcess International 4(9):24-25 (October 2006)

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