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Site Master File

The Site Master File is a document that contains all relevant information on the manufacturing and quality control processes of a pharmaceutical site.

The Site Master File (SMF) is mentioned in the EU GMP Guideline within EudraLex—Volume 4, which covers the EU pharmaceutical manufacturing and monitoring regulations. It is a crucial document for regulatory authorities to assess compliance with GMP standards in pharmaceutical manufacturing sites.

A Site Master File (SMF) is a comprehensive source of information for regulatory authorities on the specific aspects and operations of a manufacturing site in the pharmaceutical sector to demonstrate compliance with Good Manufacturing Practice (GMP) standards. The content of an SMF includes detailed information on the company’s organisation, production facilities and equipment, manufacturing processes, quality control laboratories, storage conditions, quality management systems, personnel, and environmental and safety measures, to name. Still, a few provide a complete overview of the manufacturer’s operational structure and practices.


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Site Master File

SOP-Guard ist das Herzstück der aiti-Suite. Das Programm wurde von der ersten Zeile an für die QM-Bedürfnisse von Life-Science-Unternehmen entwickelt. Zunehmend arbeiten damit auch Branchenpartner, etwa in der Logistik, die sich denselben regulatorischen Vorgaben unterwerfen müssen.