Pre-approval inspections (PAI) are triggered when a firm submits a drug application to the agency; however,
not all submissions will require a pre-approval inspection. We have some predetermined criteria for deciding whether or not to conduct a PAI. For example, if a company is applying for a new drug that involves a new technology, then that company is likely going to get a pre-approval inspection. It’s during the post-approval period that all drug companies get a GMP inspection. The FDA has initiated the risk-based site selection approach in order to prioritize and allocate federal inspection resources. This means that some high-risk firms may be inspected annually, while lower risk firms are inspected less often
