Site Master File
SMF
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A standard document prepared by a manufacturer describing the GMP-related activities carried out at a specific site — organization, personnel, facilities, equipment, and quality system — used by inspectors for pre-inspection planning and by regulatory authorities or business partners to obtain a factual overview of the site.
The site master file follows a standardized structure covering general site information, personnel, premises and equipment, documentation, production, quality control, distribution/complaints/recalls, and self-inspection, so that any inspector or partner reviewing it knows exactly where to find each category of information regardless of which company prepared it.
It is not a procedure or a batch record — it is a snapshot description of the site’s GMP status, kept current and typically updated at least every three years or whenever a significant change occurs, and it is often the first document a health authority requests before scheduling an inspection.
A site master file is distinct from a validation master plan: the SMF describes what the site is and does, while the validation master plan describes the site’s strategy and schedule for qualifying and validating its facilities, systems, and processes.
- —Follows the standardized PIC/S structure for content and section order
- —Used by inspectors for pre-inspection planning
- —Kept current and reviewed periodically, typically every ~3 years or on significant change
- —Describes the site’s GMP status — distinct from a validation master plan or an SOP
EU GMP Part III (Site Master File); PIC/S PE 008 Explanatory Notes on the Preparation of a Site Master File
Frequently asked questions
What does Site Master File stand for?
Site Master File stands for SMF.
What is Site Master File?
A standard document prepared by a manufacturer describing the GMP-related activities carried out at a specific site — organization, personnel, facilities, equipment, and quality system — used by inspectors for pre-inspection planning and by regulatory authorities or business partners to obtain a factual overview of the site.
Which regulations cover Site Master File?
EU GMP Part III (Site Master File); PIC/S PE 008 Explanatory Notes on the Preparation of a Site Master File