Six-System Inspection Model
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The six-system model is FDA's framework for organizing a drug GMP inspection around six functional systems: the quality system plus five manufacturing systems — facilities and equipment, materials, production, packaging and labeling, and laboratory controls. An inspection may be conducted as a full inspection covering the quality system plus at least three others, or as an abbreviated inspection covering the quality system plus one other, depending on the site's history and purpose of the visit. Structuring inspections this way gives coverage of the whole operation while allowing a risk-based depth.
The quality system is always in scope because it is the connective tissue — CAPA, change control, complaints, and management oversight touch every other system. The remaining five systems are sampled to build (or confirm) a picture of the overall state of control.
The model also shapes how firms prepare: mapping their operations and evidence to the six systems mirrors how the investigator will navigate the site.
- —Six systems: Quality + Facilities/Equipment, Materials, Production, Packaging/Labeling, Laboratory
- —Quality system is always covered
- —Full inspection = Quality + at least 3 others; abbreviated = Quality + 1 other
- —Enables risk-based depth with whole-operation coverage
FDA Compliance Program Guidance Manual 7356.002, Drug Manufacturing Inspections.
Frequently asked questions
What is Six-System Inspection Model?
The six-system model is FDA's framework for organizing a drug GMP inspection around six functional systems: the quality system plus five manufacturing systems — facilities and equipment, materials, production, packaging and labeling, and laboratory controls. An inspection may be conducted as a full inspection covering the quality system plus at least three others, or as an abbreviated inspection covering the quality system plus one other, depending on the site's history and purpose of the visit. Structuring inspections this way gives coverage of the whole operation while allowing a risk-based depth.
Which regulations cover Six-System Inspection Model?
FDA Compliance Program Guidance Manual 7356.002, Drug Manufacturing Inspections.