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@article{186368,
        author = {B Manasa and M Beena Devi and M.V .Nagabhushanam and Adilakshmi.Ch},
        title = {A COMPETENT REGULATORY DOCUMENT : SITE MASTER FILE},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {6},
        pages = {1297-1304},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=186368},
        abstract = {A Site Master File (SMF), also referred to as plant master file or site reference file, is prepared by the manufacturer and contains specific information about the quality management system in place, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master File need only describe those operations, e.g. analysis, packaging, etc. Guidance on the preparation and set up is provided in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) Explanatory Notes for Industry on the Preparation of a Site Master File in the current version as of July 2004 (PE 008-2). PIC/S is a cooperative arrangement between health authorities whose purpose includes leading the international development, implementation, and maintenance of harmonised GMP standards and quality systems of world-wide pharmaceutical inspectorates.},
        keywords = {Site Master File (SMF), Quality Management System, Pharmaceutical Inspection Co-Operation Scheme (PIC/S), GMP},
        month = {November},
        }