PHARMACEUTICAL DOCUMENT LIBRARY · SMF
A Site Master File brings together factual information about a pharmaceutical manufacturing site, its activities and its quality management system. Use this section to understand the document’s purpose and browse published documents and related SOPs.
Review each document’s preview, topics, page count and access details before downloading or purchasing.
Site Master File
Pharmaceutical Site Master File (SMF) template covering site information, quality systems, personnel, premises, equipment, manufacturing and quality control. Intended for QA teams preparing or updating site documentation.
36 pages · DOCX
View document detailsThe SMF describes the particular site. It should reflect the actual premises, personnel, equipment and operations rather than present a generic description of pharmaceutical manufacturing.
Company and site details, authorised activities and the scope of manufacturing operations.
An overview of quality management, release arrangements, supplier controls and quality risk management.
Organisation, training, key manufacturing areas, utilities and significant equipment.
Document control, production activities, quality control and relevant validation arrangements.
Distribution, complaints, recalls and self-inspection arrangements relevant to the site.
Keep the overview and referenced supporting information aligned with actual site activities and approved changes.
For pharmaceutical QA teams, site management and document owners preparing or updating a manufacturing-site overview.
Look for a structure you can complete with the actual site details and supporting references. Check the preview before selecting a file.
Use a procedure to define how the SMF is drafted, reviewed, approved and maintained. A procedure and the completed site document have different purposes.
They serve different purposes. The SMF describes the manufacturing site and its operations; the VMP defines the site’s qualification and validation programme.
An SOP can describe how to prepare, review and maintain an SMF. The completed SMF must contain factual information for the particular manufacturing site.
Read the preview and public contents, confirm the document format, and identify the sections that need your site information. Confirm the complete page count and included documents on the individual listing.