It is a key “modern quality systems” concept found in this FDA guidance. The FDA’s Drug Manufacturing Inspection
Compliance Program, which constitutes instructions to FDA inspectors, uses a systems-based approach for inspections. The six
systems referred to in this inspection model are: quality, production, facilities and equipment, laboratory controls, materials,
and packaging and labeling. The quality system provides the foundation for the other five manufacturing systems that are
linked and function within it. This approach emphasizes assessment of whether each of the systems is in a state of control.
