Guideline for Drug Master Files-DMF指导.doc

Guideline for Drug Master Files
 
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 (HFD-100)
5600 Fishers Lane
Rockville, Maryland 20857
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, Operating Procedures, and Personnel
b. Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
c. Type III: Packaging Material
d. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
e. Type V: FDA Accepted Reference Information
2. General Information and Suggestions
A. Environmental Assessment
B. Stability
C. Format, Assembly, and Delivery
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
A. Letter of Authorization to FDA
B. Copy to Applicant, Sponsor, or Other Holder
VI. PROCESSING AND REVIEWING POLICIES
A. Policies Related to Processing Drug Master Files
B. Drug Master File Review
VII. HOLDER OBLIGATIONS
A. Notice Required for Changes to a Drug Master File
B. Listing of Persons Authorized To Refer to a Drug Master File
C. Annual Update
D. Appointment of an Agent
E. Transfer of Ownership
IX. CLOSURE OF A DRUG MASTER FILE
GUIDELINE FOR DRUG MASTER FILES
I. 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