RT Journal Article
SR Electronic
T1 Preparation and Use of Drug Master Files in the Pharmaceutical Industry
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 63
OP 69
VO 35
IS 2
A1 Personeus, Gordon R.
A1 Ascione, Peter
YR 1981
UL http://journal.pda.org/content/35/2/63.abstract
AB The complexities of the paper documentation required by the FDA to fulfill the needs for even relatively simple submissions mandate the establishment of Drug Master Files with the Bureau of Drugs when feasible to minimize the repetitive submission of routine information. A Drug Master File established with the Bureau of Drugs is a confidential document serving as a reference source for detailed information on a plant facility, plant personnel, chemical process, packaging item or process, manufacture of a raw material and final drug dosage form, equipment, operating procedures, color additives or colorants, clinical studies or animal safety studies, and similar items or processes. The Drug Master File may be utilized either by the “holder” who establishes the file, or by one or more additional parties in support of their application when so authorized by the holder. This presentation reviews the various types of Drug Master Files which are of practical use, the important aspects in preparation and maintenance of these files, and their appropriate utilization. Emphasis will be placed on this latter point, particularly in respect to the Manufacturing and Controls and Packaging Sections of INDs, NDAs, Antibiotic Forms 5 or 6, Supplemental New Drug Applications and as support for other Drug Master Files. The important role of the supplier to the drug industry in furnishing appropriate Drug Master File letters will also be emphasized. Experience in the use of Drug Master Files with FDA reviewers will illustrate these points.