Site Master File (SMF)

Definition

A Site Master File is a document that describes the GMP-related activities of a manufacturing site, including its organization, quality management system, production facilities, and equipment. It's often requested by regulatory authorities during inspection planning or as part of a marketing authorization application.

Benefits

Keeping the SMF current and readily accessible, including accurate descriptions of EBR and other computerized systems in use, reduces preparation time when regulators request it, and ensures the document accurately reflects the site's actual quality system rather than an outdated snapshot.

Use Case

Ahead of a regulatory inspection, a site's quality team updates the Site Master File to reflect a recently implemented EBR system, ensuring the document accurately describes current computerized systems rather than referencing the paper-based process it replaced.

Frequently Asked Questions (FAQ)

Related Terms

• GMP (Good Manufacturing Practice)
• FDA (Food and Drug Administration)