Skip to content

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.

Share glossary article
aiti Glossary

Product recommendations for:

Site Master File

SOP-Guard, the heart of the aiti-suite, deals with the nature of each QM system – the document. We developed the program from the first line for the QM needs of life science and similar companies. Even industry partners are increasingly working with it, for example, in logistics, which must comply with the exact regulatory requirements.