TYPES OF DRUG MASTER FILES and Benefits of DMFs

Author: Sophiya Williams

A Drug Master File (DMF), a document submitted by the FDA, contains a lot of potentially confidential information regarding where, how and why drugs are manufactured and stored for human consumption. All DMFs must now be submitted in electronic CTD format, except Type III.

Types of Drug Master Files

Five types of DMFs are available. Each type requires different information. However, each one has the same level of detail and complexity.

Type 1 DMFs are used to refer to manufacturing facilities and procedures.

Type II DMFs refer to all processes involved in preparing the drug substance, including intermediates and drug material.

Type III DMFs can be used with packaging materials for drug products such as bottles and caps made of PVC resins.

Type IV DMFs are the excipients used to bind powder to form tablets, such as starch or cellulose.

DMF submission form

It is recommended that the Drug Master File be submitted electronically. Because submitting the Drug Master File in both paper and electronic formats may delay review.

Pre-assigned numbers are required for all electronic submissions. Converting from paper to electronic format does not require a pre-assigned number. Pre-assigned numbers must be converted to electronic format in 6-digit format. 2345 becomes 0002345. The sequence number of the first submission in electronic form must be "0000". It is necessary to submit the entire DMF electronically to convert a paper Drug Master File from an electronic format. Electronic formats can't be converted to paper formats. All subsequent submissions by the DMF holder must be made electronically.

REVIEW OF DMFs

The managed content will be reviewed once the Drug Master File has been received. This process can take several weeks. A confirmation will be issued if the DMF agrees with the managed content. The notification will also be sent to the DMF owner. If the DMF is acceptable from an administrative standpoint, the owner of the DMF number will be notified about the deficiency letters.

Only when the following events occur will a full review of the technical information in the Drug Master file be possible.

  1. DMF holders must submit a DMF Approval form (LOA) to their regulators. This LOA must contain the DMF number/acknowledgement number.
  2. The LOA is sent to the owner by the customer.
  3. The FDA receives the application from the customer containing a copy of the LOA.
  4. The EU requires that ASMF be submitted in the following sections of the CTD Module:
  • Module 1 Management and prescription information. This information is not required for ASMF.
  • Module 2 This module contains a summary of the general quality of service ("QOS") of the "applicant" (open) and "restricted" (closed) parts. This summary is a summary of information from Module 3.
  • Module 3 includes all quality information. It contains both the applicant's part and the restricted portion. It contains all information necessary for marketing approval. This restricted section contains confidential information belonging to ASMF holders. It can only be shared with healthcare authorities.
The benefits of DMF

Drug Master File protects the owner's proprietary information privacy, such as manufacturing procedures.

Manufacturers of finished products believe API manufacturers with a DMF number or CEP (Certificate of Conformity) is more reliable in terms of quality and regulation.

(Related - What is the difference between GMP, FDA, DMF, ISO, and CEP?)