Site Master File (SMF)

Mastery of a GMP system requires knowing it in detail. This applies equally to external assessments, for example by the authorities. That is why the Site Master File SMF has established itself as an overview document, recording and describing all essential elements of a GMP system. It provides a structured, summary overview of the operating establishment or site and the established GMP tools. For the pharmaceuticals manufacturer, but also for authorities conducting inspections. Valuable documentation of GMP in practice.

Structure and Content

The structure and the content itself are largely specified by guideline documents today, such as EU Vol. 4, Part III, “Explanatory Notes on the Preparation of a Site Master File”. The document should be part of quality management. Maintained with a document number and formally approved. Subject to regular reviews. It should be specific and not encompass more than 25-30 pages. Experts are in demand here who, like gempex, have an established broad range of experience in the concise yet specific and precise preparation of such documents.

The Details Count

As with other documents that need to be maintained, there are many ways to make mistakes during the preparation of the site master file. This complicates subsequent maintenance of the document! Potential problems range from incorrectly referencing too many external documents, possibly also specific versions, to the excessively detailed listing of figures or names of persons that change dynamically. Avoiding known sources of errors in the preparation of documents from the outset is the key. Or taking advantage of specific consultancy services. Know-how and what to avoid.  

How Does Preparation Work…

…without knowing all the details on site? Indeed: this requires collaboration with the customer. Yet the specific definition of documents that are required as a foundation and can generally be provided quickly makes the task significantly easier. This is where gempex works with proven checklists and questionnaires, and executes projects in clear sequences: collecting information, short interviews, draft preparation, discussion, finalisation. Clear steps, clear process.

A Site Master File Offers Even More…

A site master file should not only be prepared to meet requirements or make orientation easier for the authorities. Many companies today are already using this central document to present the well-established GMP quality system externally – in the course of customer or 3rd-party audits. Here the site master file is put on the table at the outset during the introductions, positively determining part of the audit for the customer. Customers benefit from recommendations provided by gempex, telling them what to consider for this type of use, what should be included or omitted. For flawless use.     


  • specialists who know exactly how to design an SMF and what it should contain
  • avoiding mistakes previously made by others
  • preparing an SMF as a document with multiple uses
  • assistance and professional support
  • a state-of-the-art SMF that complies with the official recommendations