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.[1]


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.[2]

See alsoEdit


  1. ^ "SMF: PIC/S explanatory notes".
  2. ^ "WHO: Guidelines for drafting a Site Master File" (PDF).