A Site Master File (SMF) is a document prepared by a manufacturer that provides specific, factual information about the production and control of manufacturing operations at a named site, as well as any closely integrated operations nearby buildings.
SMFs are internationally harmonised documents. This allows manufacturers to submit the same SMF to competent authorities in all countries for which they manufacture. Consequently, the TGA uses the PIC/S harmonised template for an SMF.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.