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The primary packaging material is defined 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.

A 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 approved nor rejected; it is reviewed 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 be submitted using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitted in eCTD format after this date will be rejected.

The types of DMFs are:

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 be some confusion regarding when a Type III DMF (packaging material) should be submitted. It is not required that packaging information is submitted 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 and may be included directly in the application.

Any information that a manufacturer does not wish to share with the applicant or sponsor may be placed 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.

Related Projects:


Name: GMP Guideline

ISO 15378 Consultant

Name: Quality Assurance ISO 15378