analytical procedures—can be accessed by reference (or links in the case of an Electronic DMF) from the relevant section for that product, e.g., 3.2.4.2 [Flavor 1]. DMF holders who submit DMFs for sterile manufacturing can consult the Manual of Policies and Procedures 5040.1: Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q). Companies don't have to file separate sections for the same product manufactured at separate facilities unless the manufacturing processes are different. Module 1 must contain the following information Section 1.2: Cover Letter and Statement of Commitment Section 1.3: Administrative Information 1.3.1 Contact/sponsor/Applicant information 1.3.1.1 Change of address or corporate name Can be used to supply addresses of DMF holder and manufacturing and testing facilities 1.3.1.2 Change in contact/agent Can be used to supply the name and address of contact persons and/or agents, including Agent Appointment Letter. 1.4.1 - Letter of Authorization (LOA) Submission by the owner of information, giving authorization for the information to be used by another. An Agent Appointment Letter is NOT an LOA and should not be called “Letter of Authorization” and should not be submitted in Section 1.4.1 1.4.2 - Statement of Right of Reference Submission by recipient of a Letter of Authorization with a copy of the LOA and statement of right of reference. Submitted in a DMF only when another DMF is referenced. 1.4.3 - List of authorized persons to incorporate by reference This list should be submitted in DMF annual reports. Section 1.12.14 Environmental Analysis: See Environmental Assessment The language in the following sentence in the DMF Guidance, Section VII.B.1, has confused some DMF holders: “A DMF is required to contain a complete list of persons authorized to incorporate information in the DMF by reference [21 CFR 314.420(d)].” It does not mean to say that a company must list all individuals in the DMF holder's company who are authorized to submit information to the DMF. The language in the CFR is clearer: “The drug master file is required to contain a complete list of each person currently authorized to incorporate by reference any information in the file, identifying by name, reference number, volume, and page number the information that each person is authorized to incorporate.” Types of DMFs Type I DMFs (Category 1) The FDA no longer accepts Type I DMFs, per a final rule published on January 12, 2000 (65 FR 1776). See Type V DMFs below.