Medicine:Site master file (pharmaceuticals)

From HandWiki
Revision as of 05:40, 10 June 2021 by imported>LinuxGuru (add)
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)

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. 




Retrieved from "https://handwiki.org/wiki/index.php?title=Medicine:Site_master_file_(pharmaceuticals)&oldid=104100"