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.

How to access a pdf document

PIC/S explanatory notes for pharmaceutical manufacturers on the preparation of a site master file (1 January 2011) (pdf,235kb)