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The GMP Inspection Triggers Decision Points Guide Template is a guide for the triggers and decision points for Track I and Track II GMP Inspections. Scheduling of routine “qualifying inspections” of Medical Device Manufacturers required by the FDA’s policies is generally covered by a Two Track GMP Inspection Strategy, which can be seen on MFG104-1 TRIGGERS AND DECISION POINTS FOR GMP INSPECTIONS.
Inspectional coverage under either the Track I or Track II approach will constitute a “qualifying inspection.” District management will determine which of the triggers listed apply to a firm scheduled for a qualifying inspection. All establishments that manufacture a class II and/or III device must receive a comprehensive (Track II) GMP Inspection once every four years.
Normally, district management will assist in making the tentative decision of whether the firm should be covered under Track I or II. The investigator may identify extensive deficiencies while performing a Track I Inspection which will require a more comprehensive inspection (Track II). District policy may require that investigators consult with their supervisors before initiating a more comprehensive inspection.