Site master file (pharmaceuticals)
A site master file or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.[PIC/S explanatory notes">]About
A site master file is a document prepared by the manufacturer containing specific and factual GMP
information about the production and/or control of pharmaceutical manufacturing operations carried
out at the named site and any closely integrated operations at adjacent and nearby buildings. If only
part of a pharmaceutical operation is carried out on the site, the site master file need describe only
those operations, e.g., analysis, packaging.
