Current challenges for FDA‐regulated bioanalytical laboratories for human (BA/BE) studies, Part II: recent FDA Inspection trends for bioanalytical laboratories using LC/MS/MS methods and FDA Inspection readiness preparation

This article is the second of a three-part series that deals with the recent Food and Drug Administration (FDA) inspectional trends for bioanalytical laboratories performing analysis for human bioavailability (BA)/bioequivalence (BE) studies. While the FDA compliance expectations have been published in various FDA guidances, as well as the Compliance Program Guidance Manual for current Good Manufacturing Practice and Good Laboratory Practice (as discussed in Part 1 of this series), there are no specific regulations that mandate the operation and control of the bioanalytical laboratories conducting analyses for human BA/BE studies. It is apparent that the compliance standards and analytical testing requirements have been subject to a dynamically evolving process, slowly developed through several workshops jointly sponsored by the FDA and the pharmaceutical industry in the past decade. As the FDA expectations in the practices of bioanalytical laboratories become clearer, an increased trend is observed for the number of FDA 483 observations and untitled letters issued. This article provides a detailed analysis of the current FDA guidance and apparent expectations based on inspectional trends observed. In addition, the compliance and scientific basis of these dynamically evolving regulatory issues are also discussed, where applicable. Copyright © 2008 John Wiley & Sons, Ltd.