This document provides guidance on Drug Master Files (DMFs) presented by Mr. S. Vibhute. It discusses the following: - The 5 types of DMFs including Type I-V and what information each type should contain. Type I is no longer used. Type II covers drug substances and intermediates, Type III covers packaging, Type IV covers excipients and Type V covers miscellaneous information. - The content and format requirements for submitting a DMF including a transmittal letter, administrative information, and detailed information for each type of DMF. Supporting documentation and guidelines should also be referenced. - Information on amendments, annual updates, and authorizing other applications to reference the

1. RJARSHI SHAHU COLLEGE OF
PHRMACY,BULDANA.
DMF( DRUG MASTER FILE).
GAUIDANCE BY PRESENTED BY
MR. S.VIBHUTE SIR. ADITI G. WAGHMARE

2.  Introduction.
 Types of DMF.
 Submission of DMF.
 General information and Suggestions.
 AuthorizationTo Refer a DMF.
 Review of DMF.
 Annual Update.

3. …Introduction.
 DMF: It is a submission to the United States
food and drug Administration (USFDA) or to
concerned the confidential detailed
information, about chemistry, manufacturing
and processing of drug product or component
of drug product.
 Other information (like packaging , storing)
may also filed in a DMF.

4.  Types of DMF

5.  TYPE I
 Type I DMF is recommended for a person
outside of United states to assist FDA in
conducting on site inspection of their
manufacturing facilities.
 The DMF should describe the manufacturing
site, equipment capabilities, and operational
layout.
 As per jan12,2000 final Rule notice:
Elimination ofType I DMF done by
july10,2000.

6. .
 TYPE II
1.It should be limited to single drug
intermediate, drug substance, drug product
and drug materials used in their preparation.
 It shall summaries all significant steps of
manufacturing and controls of the drug
intermediates substance.
 Guidelines
I. Guideline for submitting supporting
documentation in drug application for the
MFG of drug substance.

7. .
II. Guideline for the format and content of the
chemistry, manufacturing, and control section
of an application.
2.Drug Product(finished dosage forms)
manufacturing procedures and controls
for finished dosage forms
should ordinarily be submitted in an
IND,NDA,ANDA or ExportApplication.
(If can not be submitted to above documents)
It should be submitted in a DMF

8. .
 For drug product ,the applicant should follow the
guidance provide in the following guideline:
I. Guideline for the format and content of the
chemistry, manufacturing and controls section of
an application.
II. Guideline for submitting documentation for the
manufacture of and control for drug product.
III. Guideline for submitting samples and analytical
data for methods validation.

9. .
 TYPE III
packaging material
 It should include the intended use, components and
composition controls for the packaging material.
 The name of the supplier or fabricators of the
components used in preparing the packaging
material.
 Toxicological data on these material would be
include under this type of DMF.
 Guideline: guideline for submitting documentation
for packaging for human drug and biologics.
 Responsibility for compatibility and safety of
packaging components in finished drug product is
the responsibility of the AUTHARISED PARTY(AP).
 It is not the responsibility of DMF HOLDER.

10. .
 TYPE IV
Excipients, colorant, flavour..
 Each additive should be identified and
characterized by its method of manufacture,
release specification ,and testing method.
 Toxicological data on these material would be
include under this type of DMF , if not
otherwise available by cross reference to
another document.
 The DMF should include any other supporting
information and data that are not available
by cross reference to another document.

11. .
 TYPEV
 FDA discourages the use ofTypeV DMFs for
miscellaneous information, duplicate information,
or information that should be include in one of the
other types of DMFs.
 To submit data which is A holder must
Not covered in type I to IV DMF first submit a
(clinical/toxicity data) letter of intent to
the DMF staff.
FDA will then contact holder to
discuss the proposed submission

12. .
 Submission of DMF
 Each DMF submission should contain a
1. Transmittal letter
2. Administrative information
About the submission ,and the specific
information to be include in the DMF as
describe in this section.
 The DMF must be in English language.
Whenever a submission contains information
in another language ,an accurate certified
English translation must also be include.
 Each page of copy of the DMF should be
dated and numbered.

13. 1.Transmittal(cover)letter
Original submission and Amendments.
II.Original submission.
 Identification of submission.
(original/supportive to original DMF/Amendment)
 Type of DMF and subject(update, revised formula,
revised process).
 The name and address of each sponsor ,
applicant, or holder, and all relevant document
numbers.
 Signature of the holder or the authorized
representative.
 Type written name and title of the signer.

14. .
II. Amendments.
 Identification of submission : Amendment, the DMF
number, type of DMF, and the subject of the
amendment.
 A description of the purpose of submission. updates,
revise process, etc.
 Signature of the holder or the authorized
representative.
 Type written name and title of the signer.
2.Administrative information
I. Original submission.
Name and addressee of the following:
a) DMF holder.
b) Corporate headquarter.
c) Manufacturing/processing facility.
d) Contact for FDA correspondence.
e) Agent, if any.

15. .
II. Amendments.
a) Name of DMF holder.
b) DMF number.
c) Name and address for correspondence.
d) Affected section and page numbers of the DMF.
e) The name and address of each person whose
IND,NDA,ANDA,DMF or export application
relies on the subject of the amendment for
support.