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, routinedetermination of a laboratory’s compliance with the GLPs, it includes examination of anongoing 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 assurethat proper corrective actions have been taken.
GLP inspections are scheduled once every two years whereas the other kinds of inspections are scheduled as needed.
