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Site master file (pharmaceuticals)

Topic: Medicine

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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]

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.[2]

See also

References

  1. ↑ "SMF: PIC/S explanatory notes". http://www.tga.gov.au/docs/html/siteinfo.htm. 
  2. ↑ "WHO: Guidelines for drafting a Site Master File". http://apps.who.int/prequal/trainingresources/pq_pres/workshop_Vietnam_Jan2006/SiteMasterFile.pdf. 




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