Holders of Type II, III, and IV DMFs must not place information regarding facilities, personnel, or general operating procedures in these DMFs. They should only submit DMF holder addresses, manufacturing sites, and contact personnel. See Administrative Information in a DMF. Type II DMFs (Category 1) For Type II DMFs filed in CTD-Q format, the FDA expects Module 2. Drug Substance Type II DMFs for drug substances may be submitted in the format for "Drug substance" in the "Guidance for Industry M4Q: The CTD - Quality".(Category 3) Drug Substance: See the current Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances. It is not necessary to include a Methods Validation Package (3.2.R.3). Methods Validation information should be submitted in Section 3.2.S.4.3. See also the DRAFT ICH Guidance “Q11 Development and Manufacture of Drug Substances Drug Product: Type II DMFs for drug products may be submitted in the format for "Drug product" in the "Guidance for Industry M4Q: The CTD - Quality".(Category 3) Drug Product. See the Guideline For Submitting Supporting Documentation In Drug Applications For The Manufacture Of Drug Products. It is not necessary to include a Methods Validation Package (3.2.R.3). Methods Validation information should be submitted in Section 3.2.P.5.3. Examples of drugs that would be classified as Type II DMFs include Amifostine, Caffeine, Desonide Micro, Ibuprofen Softgels, Vitamin E Oil, and Zinc Gluconate. Separate DMFs should be submitted for drug substances and drug products. Type III DMFs (Category 1) The applicable Guidance for Type III DMFs is the “Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Documentation” and Questions and Answers. (Category 3) A Manual of Policies and Procedures covering reviewer responsibilities for review of Type III DMFs has been implemented. MAPP 5015.5 CMC Reviews of Type III DMFs for Packaging Materials This MAPP instructs reviewers to look for information regarding many packaging materials in the application (IND, NDA, ANDA) for the drug product that utilizes the packaging material before reviewing the DMF. Much of the information needed for review can be provided directly to the applicant for inclusion in the application, thereby avoiding the need to review the DMF. Examples of products that would be classified as Type III DMFs include bottles, seals, dispensers, and vials. Type IV DMFs (Category 3) Type IV DMFs should be used for products such as excipients, colorants, flavors, essences, or