DMF File Submission Guideline

The primary packaging material defines as the material that that may or may not be in direct contact with the dosage form. Primary packaging may comprise any single part of a container closure system including containers, container liners, closures, closure liners, stopper oversells, etc.

secondary packaging material is a packaging component that is not in direct contact with the dosage form. Current good manufacturing practice (cGMP) requirements for the control of drug product containers & closures are defined in 21 CFR Part 210 & 211.

GMP Primary Packaging Quality Assurance Services:
Operon Strategist helps manufacturers in determining whether their product is a medical device or a primary packaging material.Accordingly, if the product is a primary packaging material, the client is guided through the DMF compilation & submission process.

The manufacturer/supplier (DMF holder) files the DMF to provide information confidentially to US FDA. A DMF is neither approving nor rejecting; it is review by FDA when referenced by an applicant in a regulatory submission.

DMF File Preparation & Submission

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide classified detailed information about processes, facilities, or unit used in the manufacturing, packaging, processing, and storing of one or more human drugs.

Beginning on May 5, 2018, new DMFs, as well as all documents submitted to existing DMFs, must submit using the Electronic   Common Technical Document (eCTD)DMF submissions that are not submitting in eCTD format after this date will reject.

The types of DMFs are:

  • DMFs Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material

There appears to some confusion regarding when a Type III DMF (packaging material) should submit. It is not required that packaging information is submitting to the FDA in a DMF.

This information may be provided to the applicant by the manufacturer of a packaging component or material of construction. It may include directly in the application.

Any information that a manufacturer does not wish to share with the applicant or sponsor may place in a Type III DMF and incorporated into the application by a letter from the manufacturer to the applicant which authorizes reference to the DMF.

  • Type IV x Colorant, Flavor, Essence, or Material Used in Their Preparation.
  • Type V FDA Accepted Related Information.

Drug Master File (DMF) Guideline: FDA

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may use to provide confidential detail information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

This guideline does not impose mandatory requirements (21 CFR 10.90(b)). It does, however, offer guidance on acceptable approaches to meeting regulatory requirements. Different approaches may follow, but the applicant encourages to discuss significant variations in advance with FDA reviewers to preclude spending time and effort in preparing a submission that FDA may later determine unacceptably.

Drug Master Files are provided for in 21 CFR 314.420. This guideline is intended to provide DMF holders with procedures acceptable to the agency for preparing and submitting a DMF.

The guideline discusses types of DMF’s, the information needed in each type, the format of submissions to a DMF, the administrative procedures governing review of DMF’s, and the obligations of the DMF holder.

DMF’s are generally creating to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the information contained in its own IND, NDA, or ANDA directly rather than establishing a new DM.


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