Glossary
Site Master File (SMF)
A document summarising a site's GMP related activities, organisation, facilities and equipment, documentation, and quality control arrangements.
Source · EudraLex Volume 4, Part III, Explanatory Notes on the Preparation of a Site Master File
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
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
- 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 -
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
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EudraLex Volume 4, Part III, Explanatory Notes on the Preparation of a Site Master FileGRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
Browse the whole glossary