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.
This Site Master File template provides a structured starting point for documenting a pharmaceutical manufacturing site and its operations. It helps organise key information about the site’s quality management system, facilities, personnel and manufacturing activities. Review and customise the content to reflect your actual site, authorised operations and applicable GMP requirements before approval and controlled use.
Topics covered by this document
01Site Information and Manufacturing Activities02Quality Management and Risk Management03Personnel, Training and Hygiene04Premises, Utilities and Equipment05Documentation and Record Control06Production and Process Validation07Material Management and Warehousing08Quality Control and Stability Studies09Distribution, Complaints and Product Recalls10Self-Inspection and Supporting Annexures