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.

Additional recommended knowledge

What is the Correct Way to Check Repeatability in Balances?

How to quickly check pipettes?

Guide to balance cleaning: 8 simple steps

References

SMF: PIC/S explanatory notes 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.