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Autodesk Robot Structural 2012 Chomikuj Filmy 18 Code That Is

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A Type I DMF is normally not needed to describe domestic facilities, except in special cases, such as when a person is not registered and not routinely inspected.

Center for Drug Evaluation and Research Food and Drug Administration Department of Health and Human Services September 1989 For further information regarding the guideline please contact: Food and Drug Administration Center for Drug Evaluation and Research Office of Drug Evaluation I 10903 New Hampshire Ave White Oak Campus, Bldg 22 Silver Spring, MD 20993 TABLE OF CONTENTS I.

Administrative Information Original Submissions Amendments C.

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel b.

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation e.

Listing of Persons Authorized To Refer to a Drug Master File C.

INTRODUCTION A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

The submission of a DMF is not required by law or FDA regulation.

The information contained in 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.

Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.

This guideline does not impose mandatory requirements (21 CFR 10.90(b)).

It does, however, offer guidance on acceptable approaches to meeting regulatory requirements.

Different approaches may be followed, but the applicant is encouraged to discuss significant variations in advance with FDA reviewers to preclude spending time and effort in preparing a submission that FDA may later determine to be unacceptable.

Drug Master Files are provided for in 21 CFR 314.420.

This guideline is intended to provide DMF holders with procedures acceptable to the agency for preparing and submitting a DMF.

The guideline discusses types of DMFs, the information needed in each type, the format of submissions to a DMF, the administrative procedures governing review of DMFs, and the obligations of the DMF holder.

DMFs are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file.

The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization (21 CFR 312.3 (b)).

III. TYPES OF DRUG MASTER FILES There are five types of DMFs: Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product Type III Packaging Material Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation Type V FDA Accepted Reference Information Each DMF should contain only one type of information and all supporting data.

See Section IV.C of the guideline for more detailed descriptions of the kind of information desired in each type.

Supporting information and data in a DMF can be cross referenced to any other DMF (see Part V).

IV. SUBMISSIONS TO DRUG MASTER FILES Each DMF submission should contain a transmittal letter, administrative information about the submission, and the specific information to be included in the DMF as described in this section.

Whenever a submission contains information in another language, an accurate certified English translation must also be included.

Each page of each copy of the DMF should be dated and consecutively numbered.

An updated table of contents should be included with each submission.

IV. A. Transmittal Letters The following should be included: IV.

A.1. Original Submissions a.

Names and addresses of the following: (1) DMF holder.

Corporate headquarters.

Manufacturingprocessing facility.

Contact for FDA correspondence.

Agent(s), if any.

The specific responsibilities of each person listed in any of the categories in Section a.

Statement of commitment.

The DMF should describe the manufacturing site, equipment capabilities, and operational layout.

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