Based on the program, there are 6 “systems” an FDA inspector may look at:Quality System (change control, batch release, annual product review, validation, etc.)
- Facilities and Equipment System (maintenance, utilities)
- Materials System (quality control, raw materials, inventory control)
- Production System (process validation, in-process sampling and controls, manufacturing procedure)
- Packaging and Labeling System (packaging processes, label inspection, etc.)
- Laboratory Control System (procedures, testing, analytical methods)
An inspection will always look at the Quality System. A full inspection typically looks at 3 or more additional systems. An abbreviated inspection may look at only one additional system.
One FDA auditor has said the three documents they always ask for first are: Quality Policy/Manual, Annual Product Review (APR), and Org. Chart.