FDA performs four kinds of inspections related to the GLPs and nonclinical laboratory
studies. These include: A GLP inspection an inspection undertaken as a periodic, routine
determination of a laboratory’s compliance with the GLPs, it includes examination of an
ongoing study as well as a completed study; A data audit – an inspection made to verify that
the information contained in a final report submitted to FDA is accurate and reflected by
the raw data; A directed inspection any of a series of inspections conducted for various
compelling reasons (questionable data in a final report, tips from informers, etc.); A follow up
inspection – an inspection made sometime after a GLP inspection which revealed
objectionable practices and conditions. The purpose of the follow-up inspection is to assure
that proper corrective actions have been taken. GLP inspections are scheduled once every
two years whereas the other kinds of inspections are scheduled as needed.
