Definition

Inspection of manufacturing and/or clinical sites conducted by the regulatory authority before approving an application (e.g. NDA, BLA, MAA) to verify data and compliance.

Example

FDA may inspect the commercial manufacturing site and key clinical sites before granting approval to ensure data integrity and GMP readiness.

Regulatory source

FDA PAI Program, EMA pre-authorisation inspections

Common mistakes

Not being inspection-ready: missing validation, incomplete batch records, or inadequate quality systems.

Inspector question

How did you prepare for the pre-approval inspection? Show validation and batch documentation.

Related terms