Master records are authorized documents that contain the information to perform and control process operations and activities related to the manufacture of a product.
This article summarizes the requirements requested by the Food and Drug Administration (FDA) in its draft published in October for the master drug records or documents of pharmacological substances, packaging material, etc. The second section discusses the regulatory requirements for master documents submitted in sanitary registration applications in USA.
Guidance proposal for the industry
The FDA 510k Certification published in October the draft of the guide for the industry on the Master Drug File the guide provides the way to prepare the documentation on the facilities, processes or materials used in the manufacture, the manufacturing process, packaging and storage of medicines for human use.
The information described in the guide is not mandatory by any legal provision and the sending of the same is left to the consideration of the holders of the DMF. They can be used to support New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Investigational Drug Applications (INDs).
The guide proposes four types [1] of DMF's:
- Type II. Pharmacological substance, intermediate and its raw materials for its manufacture.
- Type III. Packaging materials.
- Type IV. Excipients, colorings, flavorings, essence or material used for its preparation.
- Type V. Accepted reference information.
Filing of the DMF is subject to the electronic filing requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) section 745A guidance and complying with the electronic common technical document (eCTD) format and Guidance ICH M4.
The DMF can be presented in original in the eCTD format, US FDA Registration for this the holders must have a pre-assigned number and a letter of presentation of technical administrative information based on the eCTD.
