When I worked in the pharma production area, I have read on the label of different raw material that it is “DMF Grade” . What does DMF grade raw material signifies? Can someone share some information in this regard. Thanks in advance.
A drug master file is a document submitted to Regulatory authrities that contains all details of the manufacturing process of an API or excipient. This includes information on chemical properties of the API, the facilities used, the processes used, details on packaging, storage, etc. In order to protect the intellectual property of the manufacturer, this document is confidential. There are two parts of DMF, the open part and the closed (confidential) part.
A DMF IS NEVER APPROVED OR DISAPPROVED. The Regulatory authority will review information in a DMF only when an IND sponsor, an applicant for an NDA, ANDA, or Export Application holder incorporates this API material - DMF by reference in his finished product dossier (IND, ANDA. NDA).
According to USFDA, following types of Drug Master Files (DMFs) are there,
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product.
Type III Packaging Material.
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
Type V FDA-Accepted Reference Information.
Countries may have different guidance compared to other countries, that’s why different types of DMF exist. For example, you may have a US DMF, ASMF (formally known as EDMF), Japanese DMF, Chinese DMF, etc.
@sunilrbudhkar Thank you!
You are always welcome.