This guidance provides FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.
DMFs can contain other types of information as well (e.g., toxicology information, shared system REMS (risk evaluation and mitigation strategy)). DMF holders can authorize one or more applicants or sponsors to incorporate by reference information contained in the DMF without having to disclose that information to the applicants or sponsors.
DMFs are submitted solely at the discretion of their holders and are not required by statute or regulation. They are not typically submitted for non-proprietary materials.
Ordinarily, FDA neither independently reviews nor approves DMF submissions. Instead, FDA customarily reviews the technical contents of DMFs only in connection with the review of applications that reference them.
DMFs can be used to support (but are not substitutes for) applications reviewed by FDA.
A site master file is a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings.
A site master file or SMF is a document in the Pharmaceutical Industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer e.g., analysis, packaging.