Glossary

Site Master File (SMF)

A document summarising a site's GMP related activities, organisation, facilities and equipment, documentation, and quality control arrangements.

Details

The site master file is an up to date document that summarises the site's quality system, organisation, facilities and equipment, and its manufacturing, testing, storage, and contracted activities so that a regulator can understand them in advance. Inspections cite the actual organisation, drawings, product scope, processes, or outsourcing arrangements differing from the file, and significant changes not carried into it. Cross-check the approved version and its revision history against the manufacturing authorisation, the organisation chart, layout and personnel and facility drawings, and the lists of products and contract acceptors.

Related sections

EU GMP Part III, Site Master File Explanatory NotesPIC/S PE 008-4

Related terms

Pharmaceutical Quality System (PQS)22 casesDocumentation1,297 casesManufacturer154 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. - storage of APIs for sale under uncontrolled conditions, in a room not included in the Site Master File.
    EMA · EU GMP NCR (EudraGMDP) · 2024-09-23
  2. This building was not declared in the Site Master File, and it is not authorised for the manufacture and/or storage of medicinal products and active substances.
    EMA · EU GMP NCR (EudraGMDP) · 2026-07-13
See 5 findings that mention this term

Source

EudraLex Volume 4, Part III, Explanatory Notes on the Preparation of a Site Master File
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