The outlines of this guide could also be used in the preparation of a Site Master File or corresponding document by Blood and Tissue Establishments and manufacturers of Active Pharmaceutical …

Based on the Explanatory notes for pharmaceutical manufacturers on the preparation of a site master fi le of the Pharmaceutical Inspection Convention.

Mar 24, 2025 · The Site Master File (SMF) is a crucial document in pharmaceutical manufacturing, providing a comprehensive overview of a facility’s operations and quality management systems.

List of GMP inspections of the site within the last 5 years; including dates and name/country of the Competent Authority having performed the inspection. A copy of current GMP certificate (Appendix …

Sep 5, 2025 · When submitted to a regulatory authority, the Site Master File should provide clear information on the manufacturer’s GMP related activities that can be useful in general supervision …

Nov 8, 2024 · A Site Master File (SMF) in the pharmaceutical industry is a key document that provides comprehensive information about a manufacturing site. It serves as a reference for regulatory …

A Site Master File (SMF) in pharmaceutical production is a document that contains information and descriptions about a pharmaceutical manufacturing site and its facilities.

May 2, 2025 · A Site Master File (SMF) is a formal document prepared by pharmaceutical manufacturers, containing detailed information about the manufacturing site’s operations, quality …

A Site Master File is a document detailing a pharmaceutical manufacturing site's quality management, operations, and GMP compliance overview.

Sep 26, 2020 · The Site Master File (SMF) Document shall contain specific information about the quality management policies, activities of the site, the production and/or quality control, pharmaceutical …