regulatory affairs and submission aid

1. Presented By
Mr. Shubham Radhesham Biyani
M. Pharmacy (pharmaceutics)
Guided By
Prof. Mr. Patwekar S. L. sir
SCHOOL OF PHARMACY S R T M UNIVERSITY NANDED

2. 1. Introduction
2. Types of DMF
3. Basic Terminology in DMF
4. Submission of DMF
5. Letter of Authorization (LOA)
6. Difference between Application and DMFs
7. Drug product (Finished dosage form)
8. References

3.  A drug master file (DMF) is a submission to USFDA or
concern regulatory authority that is used to provide
information about chemistry, manufacturing and controls
of drug product or a component of drug product.
 Other non CMC information like packaging , storing may
also filled in DMF .

4. Type Essential Content
 Type 1 Mfg site , fascilities , Operating procedure
& personnel
 Type 2 Drug substances , intermediate , drug
material used & Drug product
 Type 3 Packaging Material
 Type 4 Excipients
 Type 5 FDA accepted reference information

5.  conducing on site inspection .
 This shall describe mfg site include acrage ,site address
, map showing location with respect to nearest CITY
 It is recommended for person outside united state to
assist FDA equipment with respect to of capability,
location & operating layout .
 domestic fascilation need to describe in case like when
person is not either register & routenly inspected .

6.  It should limited to single drug intermediate , drug
substance & drug product used in preparation .
 It consist summarized significant step in mfg &
control .

7. TYPE 3 Packaging Material
 The name of supplier or fabrication of component of
packaging material along with accepted specification
should mentioned.
 Toxicological data of material also include in this type
of material

8.  specification , testing method of excipients should be
submitted .
TYPE 5. FDA accepted reference information
 It is for miscellaneous information or information that
should be included in other type of DMF ( Type1 to
Type 4 ) .

9.  HOLDER :- person /company who submit DMF.
 Agent :- person / company who represent DMF holder .
 Applicant / customer / authorised party (AP):-
person / company who refer DMF .
 Application :- ANDA , NDA , IND etc

10. It should contain -
1. transmittal letter
2. Administrative information
3. Technical information
 Follows guideline at---
 www.fda.gov/cder/guidence/dmf.htm

11. send a letter to
 remind holder
 obligation
Send 2 copies of LOA to the FDA

 1 copy of LOA to the applicant

 The applicant submits this
 copy of LOA in their application
USFDA
DMF HOLDER

12. 
Application DMF’S
1. Comes under regulatory
status, must be filled by
applicant
1 . Not comes under regulatory status , is
not mandatory to file
2. Submitted to a particular
review division .
2. Submitted to CDR (central document
room)
3. Review procedure quite
different than DMF
3. DMF review only when referenced by
another application or DMF

13. should ordinarily submitted in an IND, NDA ,
ANDA or Export application .
If can not be submitted to
above document
It should be submitted in DMF . (stored at CDR)
Mfg procedure & control for
finished dosage form.

14. 1 .Drug Regulatory Affairs by sachin Itkar
2. www.fda.gov/cder/guidenc/dmf.htm
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