The Department of Health requires us to submit a “Site Master File” (Site Master File, SMF). What is this document, and how should we prepare it?

A Site Master File (SMF) is a detailed document prepared by a medicine manufacturer or wholesaler describing the company’s activities relating to the handling of medicines (such as production, packaging, quality control and distribution). It does not replace documents such as master batch records; rather, it provides an overview of the company’s overall quality management policy and activities, enabling the regulatory authority to gain a clear and comprehensive understanding of the company before an on-site inspection. The SMF follows a set format and usually includes basic company information, the Quality Management System, personnel and organisational structure, premises and equipment, the document management system, production operations, quality control, distribution/complaint/recall activities and self-inspection. Preparing an SMF requires the systematic review and summary of all relevant company SOPs and policies, presented clearly, concisely and accurately.