An insight into the Drug Master File
A Drug Master file is submitted to the Food and Drug
Administration. It contains of the most secretive and valuable information
about the different drugs, their process of manufacturing, facilities, and
storage processes as well as packaging. It is used to provide confidential information
about food and health products as well.
What is a Drug master file?
A fda drug master file guidance is submitted to the
FDA and is used specially to provide confidential and detailed information about
the different kind of facilities, processes, materials used in manufacturing
and processing the drugs, packaging and storing, as well as a variety of other
confidential information. It is not legally required to submit a DMF however it
is submitted according to the preference of the holder. The information, which
is contained in the DMF, can be used to support various kinds of investigations
related to drugs.
What are the different types of Drug master files?
There
are various kinds of Drug master files depending on the types. They can be
divided into manufacturing sites, facilities, operating procedures and
personnel in Type 1, Drug substance and materials used in their preparation for
type 2, Packaging materials in type 3, Colors, flavors, essence and materials
used in type 4, FDA accepted reference information in Type 4.
Can all people have access to the Drug master file?
No.
All people do not have access to the drug
master file. In order to access a drug master file, you need to have an
authorization letter to the FDA as well as a copy of the applicant, Sponsor and
copies of the holder. There is a listing of different people who can only have
access to the drug master file.
What should a drug master file submission file contain?
A
Drug Master File submission should contain a transmittal letter, administrative
information about the submission as well as varieties of specific information
that is included in the DMF. The copy should be in English language. If the
submission contains any other language, then it should definitely be
accompanied by another English language. Otherwise the file would be rejected.
Each page of the DMG should be consecutively numbered and dated properly. An
updated table of content should always be included with every submission.
What should the letter of authorization to DMF contain?
The
letter of authorization to US FDA DMF should contain the date of the submission, the
name of the DMF holder, the DMF number, the name of the people who are
authorized to incorporate information, the products that are covered by the
DMF, submission dates, Section numbers and page numbers, statement of
commitment, signature of the authorizing official, the Typed name and title of
official authorizing reference to the DMF.
The
Drug master Technical file is reviewed by the agency only if an IND sponsor, an applicant
for NDA, or export application, or a DMF holder incorporates the materials in the
DMF with the help of proper reference. Incase a change in the Drug Master file
is required, a holder must notify each affected applicant or sponsor who has
referenced its DMF. The notice must be provided before making the change so
that the DMF can be rectified or amended.