DRUG MASTER FILE (US-FDA)
13,Dec 2019 Mir Shahroz
For DMF preparation/Compilation, eCTD-DMF, GAP analysis, Technical review, Deficiency response (Agency or Client) etc,
mail: firstname.lastname@example.org; Phone: +91-9264127040
DRUG MASTER FILE (According to USFDA)
- A Drug Master File (DMF) contains confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
- The DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.
- A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.
Content of DMF:
Each DMF submission should contain:
- Transmittal letter
- Administrative information about the submission
- Drug Master File Contents
1. Transmittal letter for Initial/Original submission or Amendments:
A letter having the following information:
- Define the type of DMF submission
- Identification of the application
- Signature of the holder/Representative with his typed name and Title
2. Administrative information about the submission for Initial/Original submission or Amendments:
The following information should be as part of administrative information:
For original/Initial application:
a. Names and addresses of the following
- DMF holder.
- Corporate headquarters.
- Manufacturing/processing facility.
- Contact for FDA correspondence.
- Agent(s), if any.
b. The specific responsibilities of each person listed in any of the categories in Section a.
c. Statement of commitment.
A signed statement by the holder certifying that the DMF is current and that the DMF holder will comply with the statements made in it.
For Amendments of initial approved application/submission
a. Name of DMF holder.
b. DMF number.
c. Name and address for correspondence.
d. Affected section and/or page numbers of the DMF.
e. The name and address of each person whose IND, NDA, ANDA, DMF, or Export Application relies on the subject of the amendment for support.
f. The number of each IND, NDA, ANDA, DMF, and Export Application that relies on the subject of the amendment for support, if known.
g. Particular items within the IND, NDA, ANDA, DMF, and Export Application that are affected, if known.
3. Drug Master File Contents:
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
The information should be containing:
Site master file (Manufacturing site, equipment capabilities, and operational layout).
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Refer the following guideline:
Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application.
Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products
Guideline for Submitting Samples and Analytical Data for Methods Validation.
Type III: Packaging Material
The type III DMF contains about the packaging materials:
- intended use,
- and controls for its release.
- The names of the suppliers or fabricators of the components used in preparing the packaging material and the acceptance specifications
- Data supporting the acceptability of the packaging material for its intended use should also be submitted as outlined in the "Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics."
- Toxicological data on these materials would be included under this type of DMF, if not otherwise available by cross reference to another document.
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
The each additive DMF contains the following:
- Identification/Characterization data
- method of manufacture
- release specifications, and testing methods.
- Toxicological data
Usually, the official compendia and FDA regulations for color additives (21 CFR Parts 70 through 82), direct food additives (21 CFR Parts 170 through 173), indirect food additives (21 CFR Parts 174 through 178), and food substances (21 CFR Parts 181 through 186) may be used as sources for release tests, specifications, and safety. Guidelines suggested for a Type II DMF may be helpful for preparing a Type IV DMF. The DMF should include any other supporting information and data that are not available by cross reference to another document.
Type V: FDA Accepted Reference Information
FDA discourages the use of Type V DMF's for miscellaneous information, duplicate information, or information that should be included in one of the other types of DMF's. If any holder wishes to submit information and supporting data in a DMF that is not covered by Types I through IV, a holder must first submit a letter of intent to the Drug Master File Staff (for address, see D.5.a. of this section). FDA will then contact the holder to discuss the proposed submission.
Drug Master File submissions and correspondence should be addressed as follows:
Drug Master File Staff
Food and Drug Administration
5901-B Ammendale Rd.
Beltsville, MD 20705-1266