Site Master File

Site Master File

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.

References

[http://www.tga.gov.au/docs/html/siteinfo.htm SMF: PIC/S explanatory notes]

A site master file is a document prepared by the manufacturer containing specific and factual GMPinformation about the production and/or control of pharmaceutical manufacturing operations carriedout at the named site and any closely integrated operations at adjacent and nearby buildings. If onlypart of a pharmaceutical operation is carried out on the site, the site master file need describe onlythose operations, e.g., analysis, packaging.


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