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Drug master file (DMF): FDA Guidelines

A Drug master file is a submission to the Food and Drug Administration (FDA) which provide confidential detailed information about facilities, processes, or article utilize In the manufacturing, processing, packaging and storing of one or more human drugs. Drug Master Files are provided for in 21 CFR 314.420.

DMF required for: DMF is mainly used to support an investigational new drug application (IND) and (NDA). The DMF file only review in connection with these files (IND, NDA, and ANDA)

DMF is not required for: Either any Law and by FDA

Types and content of the DMF or FDA master file:

There are five types of Drug Master Files, and they include:

Type I: Manufacturing Site, Facilities, Operating Procedures, And Personnel: A type I DMF is suggested for a person outside the US to assist the FDA in conducting on-site inspections of their manufacturing facilities. The DMF should describe the manufacturing site, equipment capabilities, and operation layout. The description of the site should include acreage, actual site address, and a map showing its location with respect to the nearest city. An aerial photograph and a diagram of the site may be helpful.

A diagram of major production and processing areas is helpful for understanding operational Layout. Major equipment should be described in terms of capabilities, application, and location. Make and model would not normally be needed unless the equipment is new or unique.

A diagram of major corporate organizational elements, with key manufacturing, quality control, and quality assurance positions highlighted at both the manufacturing site corporate headquarters, is additionally helpful.

  1. Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product:

A Type II DMF should, in general, be limited to a single drug intermediate, drug substance, drug product, or type of material used in their PreparationPreparation. For drug intermediate, drug substance summaries all significant steps in the manufacturing and controls of the drug intermediate or substance.

For drug product manufacturing procedures and controls for finish dosage forms should ordinarily be submitted in an IND, NDA, ANDA, or Exports Application. If all this information cannot be submitted in an IND, NDA, ANDA, or Export Application, It should be submitted in a DMF. When Type 11 DMF is submitted for a drug product, an intermediate product special guide should be followed.

  1. Type 111: Packing material.

Each packaging material should be identified by the intended use, Components, compositions, and controls for its release. The names of the Supplier or fabricators of the Components used in the PreparationPreparation of packaging material and acceptance specifications should be given. Data supporting the acceptability of the packaging material for its intended use should even be submitted as outlined within the guideline.

  1. Type IVExcipient, Colourant, Flavour, essence, or Material used in their PreparationPreparation:

Each additive should be identified and characterized by its method of manufacture, release specifications, and testing methods. Toxicological data on these materials would be included under this sort of DMF, if not otherwise available by cross regard to another document.

Usually, the official compendia and FDA regulations for Colour 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 Park I S I through 186) may be used as a source for release, tests, specifications, and safety.

  1. Type V: FDA Accepted Reference Information :

FDA discourages the utilization of type V DMF’s for miscellaneous information, duplicate information, or information that ought to be included in one among the opposite sort of the DMF’s.

If any holder wishes to submit the information that supporting data in DMF that is not covered Type I through IV, a holder must first submit a letter of intent to the DMF Staff. FDA will then contact the holder to debate the proposed submission.

Type 1 Type II and sort IV DMF’s should contain a commitment by the firm that its facilities be operated in compliance with applicable environmental laws.

Type 1 Type II and Type IV DMF’s should contain a commitment by the firm that its facilities be operated in compliance with applicable environmental laws.

Document Format for DMF:

Drug master file holders and their agents/representatives should retain an entire reference copy that’s similar to and maintained within the same chronological order as their submissions to FDA.

The original and duplicate copies must be collated, fully assembled, and individually jacketed. Each volume of a DMF should, generally, be no over 2 inches thick. For multivolume submissions, number each volume. For example, for a 3 volume submission, the volumes would be numbered one of three, two of three, and three of three.

US standard paper size (8-1/2 by 11 inches) is preferred. Paper length shouldn’t be less than 10 inches nor over 12 inches. However, it should occasionally be necessary to use individual pages larger than the standard paper size to present a plan.

Synthesis diagram, batch formula, or manufacturing instructions. Those pages should be folded and mounted to permit the page to be opened for review without disassembling the jacket and refolded without damage when the quantity is shelved.

The agency’s system for filing DMF’s provides for assembly on the left side of the page. The left margin should be at least three-fourths of an inch to assure that text is not obscured in the fastened area. The right margin should be a minimum of one-half an inch. The submitter should punch holes 8 1/2 inches apart on each page.

Adress for submitting 21 CFR 314.420 drug master files:

Drug Master File Staff

Food and Drug Administration

5901-B Ammendale Rd.

Beltsville, MD 20705-1266


Food and Drug Administration guidelines

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