Aug. 23, 2022
Types of VMFs and Their Content
Type I VMF’s are obsolete, and we no longer accept them. Type II through Type VI VMFs are considered manufacturing VMFs; information concerning post-approval manufacturing changes for both the VMF holder and the authorized users can be found in CVM Guidance for Industry #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA.
Type II: Manufacturing Information for Drug Substances and Intermediates includes manufacturing information used to support the production of the drug substance intermediates, bulk drug substance, medicated articles, medicated feeds, or finished dosage forms. These VMFs should be limited to a single drug intermediate or drug substance. This information may include general information on the molecule, information on the manufacturing facility, details of the manufacturing or fermentation process used, and controls such as release and stability tests and methods.
Type III: Packaging Material includes information to support the intended use, components, composition, and controls of packaging materials (i.e., vials, bottles, stoppers, syringes), information about the suppliers/fabricators of the components, and data supporting acceptability of the packaging material for its intended use. Such data may include evidence of compliance with USP <660> Containers – Glass or <661> Plastic Packaging Systems and Their Materials of Construction and 21 CFR Parts 175 through 178, Indirect Food Additives.
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation includes identification and characterization data such as method of manufacture, release specifications, and testing methods may be submitted in a Type IV VMF for materials intended for use in veterinary pharmaceuticals but not intended to be active ingredients. Toxicological data for these substances may be included under this type of VMF if the data are not otherwise available by cross-reference to another document. Type IV VMFs should include any other supporting information and data that are not available by cross reference to another document.
Type V: FDA Accepted Reference Information includes non-product-specific information to support the manufacturing site, facilities, personnel, environmental safety studies, operating procedures and controls for finished dosage forms or medicated articles, and sterilization process validation for producing sterile dosage forms and sterile bulk drugs. Type V VMFs may also include animal effectiveness, safety, residue chemistry and metabolism, or toxicity information and data that may be applicable to more than one animal drug application.
Type VI: Free-Choice Medicated Feeds and Medicated Feed Assay Methods includes information about free-choice medicated feeds and medicated feed assay methods, including effectiveness/consumption data for a free-choice feed as described in CVM Guidance for Industry #13--Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block.
Type VII: Information to support the Division of Animal Bioengineering and Cellular Therapies (DABCT) project information and Tech Team Working Process includes information to support the Division of Animal Bioengineering and Cellular Therapies (DABCT) project information and Tech Team Working Process. Type VII master files are not considered manufacturing VMFs.
Type VIII: Import Tolerance Requests will be reviewed by the Division of Human Food Safety and Environmental Safety Team with the Office of Surveillance and Compliance. Type VIII master files are not considered manufacturing VMFs. See Import Tolerances for more information.
Source from FDA
Mob.: +86 157 3193 8681
E-mail: [email protected]
whatsapp/wechat: +86 15731938681