FDA原辅包登记*DMF
Site information
药物主文件，即Drug Master File (DMF)，是呈交FDA的存档待审资料，资料内容包括有关在制造、加工、包装、储存、批发人用药品活动中所使用的生产设施、工艺流程、质量控制及其所用原料、包装材料等详细信息。
Highlights
**FDA Drug Master Files (DMF)**
The FDA Drug Master File (DMF) system is a voluntary program that allows certain human drug and biological product manufacturers and their agents to submit confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. The submitted information is used by the FDA to evaluate the suitability of the facilities, processes, or articles for their intended use in the manufacturing of human drug products.