« Back to Blog

Why Drug Master Files Are Important and How to Create One

Why Drug Master Files

Drug Master Files, or DMFs, are submissions to the Food and Drug Administration that provide confidential, detailed information about facilities, processes and other specifics used to manufacture, process, pack or store drugs intended for human use.

They streamline the process of securing FDA approval for medical and pharmaceutical plastics applications, which can help a manufacturer or brand owner get products to market faster.

DMFs fall into five categories, according to the FDA:

  1. Type I for manufacturing facilities and procedures
  2. Type II for drug substances and preparation
  3. Type III for packaging materials
  4. Type IV for excipients, flavors, and colorants
  5. Type V for FDA accepted reference information

One of the primary benefits of DMFs is that they are kept confidential, allowing a manufacturer to disclose important safety-related information without disclosing proprietary business information.

Pharmaceutical businesses and associated firms and vendors often look for suppliers whose products are pre-packaged with DMFs to cut down on delays in getting their products to market. Companies that maintain up-to-date DMFs tend to be viewed as more credible by customers and clients.

“API (Active Pharmaceutical Ingredients) manufacturers with a large number of DMFs are often considered more reliable in terms of quality, regulatory standing, and ability to meet Current Good Manufacturing Practice (cGMP) requirements,” according to Balance.com, a financial website.

The FDA does not require DMFs for raw materials or components used in the preparation of drug substances. If one is filed, however, the FDA may reference it in new drug applications as an indication that all sites, processes, and materials are safe for use with pharmaceutical products.

Submitting a DMF

All Master File (MF) applications must be submitted in Electronic Common Technical Document (eCTD) format. A cover letter with clear, concise information including U.S. agents’ names and contact information is also required, along with hyperlinks to response documents if the applicant is responding to a request for information.

As long as eCTD submissions are smaller than 10GB in size, DMFs can be submitted via the Electronic Submission Gateway (ESG). To use this format, the filer must have an approved, open account with ESG. Accounts are free, but the ESG account must include a digital certificate for each person who will be using the system.

The FDA offers a Master File Tips download that stresses organization when sending large amounts of documents with DMF submissions. Tips include:

  1. All PDFs need to abide by the FDA’s PDF specifications.
  2. Submitting in eCTD format means that paper copies are not needed.
  3. Documents longer than five pages should include bookmarks, tables of contents and hyperlinks.
  4. Wherever possible, documents should not be scanned. The FDA prefers native formats converted to PDF.
  5. Ensure that all pages are properly oriented to the viewer.
  6. Leaf titles in documents need to be clearly understood and representative of what will be seen in each section.

Before filing a DMF, submitters should request an application number from either the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research.

DMFs often include reviewers guides that offer a high-level overview of the submitted documents, annual reports, risk evaluations and mitigation strategies, literature references, bioequivalence summaries, data sets, study reports, listings of all clinical studies, safety report and any other information that helps substantiate that a product, material or process as worthy of a DMF.

Plastics Color Corporation & DMFs: One Less Thing to Worry About

Filing a DMF can be a complicated, time-consuming process. Plastics Color Corporation owns a number of DMF formulations and maintains a catalog of colors, additives and concentrates packaged with FDA-accepted DMFs. Having this information on hand expedites the product-development process and also allows brand owners to change molders, if they prefer.

For more information about DMFs as well as our quality compliance and lab services, please complete the form located at the bottom of this page.

Close Pop Up