Guideline for Drug Master Files-DMF指导原则.docVIP

Guideline for Drug Master Files ? Center for Drug Evaluation and ResearchFood and Drug AdministrationDepartment of Health and Human Services September 1989 For further information regarding the guideline please contact: Food and Drug Administration TABLE OF CONTENTS I. INTRODUCTION II. DEFINITIONS III. TYPES OF DRUG MASTER FILES IV. SUBMISSIONS TO DRUG MASTER FILES A. Transmittal Letters Original Submissions Amendments B. Administrative Information Original Submissions Amendments C. Drug Master File Contents 1. Types of Drug Master Files a. Type I: Manufacturing Site, Facilities, Operati