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What is a Drug Master File? 
DR ANTHONY MELVIN CRASTO 
An introduction with case study of an API 
1
 LEADS:  1. Introduction to DMFs 
 2. Drug master file process 
 3. Drug master file format 
 4. Drug Master File contents 
4.1 Submission of DMF 
4.2 Authorization to refer to a drug master file 
4.2.1 Format for Letter of authorization to review DMF 
4.3. Processing and reviewing policies 
4.4. Changes in DMFs 
4.5. Closure of a drug master file 
4.6. Retiring DMFs 
 5.Electronic Filing of DMFs and CTD 
 6. Changes in DMF system: 
 7.Application 
 8. Difference in European DMFS compare to us DMFs 
 9. European DMFs 
 10. Difference in European DMFS compare to US DMFs 
 11. Case study 
 12. References 
LEAD POINTS
Executive Summary: Drug Master Files 
Closed DMFs: The FDA Way 
Mixed ASMFs: The European Way 
Harmonizing: the eCTD challenge 
Global Trends: The Future of DMFs 
Questions 
Agenda
10/21/2014 
2) Drug product 
 Manufacturing procedures and controls for finished dosage forms 
DR ANTHONY 
Submitted in an IND, NDA, 
ANDA, or Export Application. 
If cannot be submitted in an IND, NDA, 
ANDA, or Export Application. 
Submitted in a DMF.
Drug Submissions: US, Canada, EU 
TYPES OF DRUG SUBMISSIONS: US, Canada, EU 
USA New Drug Application (NDA), for new drugs 
Accelerated New Drug Application (ANDA)-for generics 
Biologic License Application (BLA), for biologic 
Canada New Drug Submission (NDS) for both ― drugs and biologic 
products 
EU Marketing Authorization Application (MAA)―via the Centralized 
Procedure for eligible products. For other products, via the 
decentralized, mutual recognition or national authorization are 
applicable.
Role of DMFs 
Supporting documents for the registration / 
approval of drug products 
In the Chemistry, Manufacturing and Controls (CMC) sections of the drug 
submission, the DMF documents the drugs identity, purity, strength and quality. 
Protect Proprietary and Confidential Information
DMFs Globally 
Highly Regulated Markets (Drug Master Files used to support approval process) 
United States: 
Canada: 
Australia 
Japan 
Europe: China is developing its own DMF system 
Nearly Regulated Markets (Technical Package / Registration Dossier) 
Brazil 
Russia 
South Africa 
Less Regulated Markets (No Drug Master Files used in registration process) 
India and many others
Drug Master Files: USA 
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 drugs. 
There is no legal or regulatory requirement to file a DMF. 
A DMF may be filed to provide CMC information that the FDA 
reviews instead of including this information in the Application 
(IND, NDA, ANDA). 
A DMF is neither approved nor disapproved by the FDA. 
It is provided for in 21 CFR 314.420 (Code of Federal 
Regulations)
The US DMF System 
“Closed”
DMF – US: Important Facts 
DMFs are Confidential (Closed) 
DMF Stakeholders 
DMF Holder: Company or Person who submits the DMF 
Applicant: Company or person who references the DMF in an 
application or another DMF 
Information contained in a DMF may be used to : 
Support an Investigational New Drug Application (IND)) 
Support a New Drug Application(NDA) 
Support an Abbreviated New Drug Application (ANDA) 
Support another DMF 
Support an Export Application 
Support amendments and supplements to any of these. 
10
How the US DMF System Works 
Filing the DMF 
Holder sends two copies of the DMF to FDA 
DMF is reviewed for administrative purposes only by Central 
Document Room staff 
DMF entered into database, assigned a number and 
acknowledgment letter sent to holder 
A DMF is neither approved or disapproved 
Accessing the DMF: Letter of Authorization (LOA)
The DMF will be reviewed only when it is referenced in an Application or another DMF 
The Holder must submit a two copies of the LOA to the DMF, plus a copy to the Applicant 
The Applicant submits a copy of the LOA in their Application 
The LOA is the only mechanism to trigger a review of the DMF by the FDA 
DMF Review Procedure 
The DMF is reviewed only if referenced by an Applicant or another DMF 
If the reviewer finds deficiencies in the DMF, the deficiencies are detailed in a letter to the 
Holder 
The Applicant will be notified that deficiencies exist, but the nature of the deficiencies are not 
communicated to the Applicant
US DMFs - Types 
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). 
The Main Objective of the DMF is to support regulatory requirements and to prove the 
quality, safety and efficacy of the medicinal product for obtaining an 
Investigational New Drug Application (IND), a New Drug Application (NDA),As an 
Abbreviated New Drug Application(ANDA), another DMF, or an Export Application. 
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel 
No longer accepted by the FDA (as of January 2000) 
Type II – Drug Substance, Drug Substance Intermediate, and Material Used in Their 
Preparation, or Drug Product 
Type III – Packaging 
Type IV – Excipients, Colorant, Flavor, Essence, or Material Used in Their Preparation 
Type V – FDA Accepted Reference Information 
Used for sterile manufacturing plants and contract 13 facilities for biotech products
The EU DMF (ASTM) System 
“Open & Closed”
EU DMF (EDMF or ASMF) 
The content and the format for drug master file used in United States differs from that 
used in European Countries to obtain market authorization (MA). The Main Objective 
of the EDMF is to support regulatory requirements of a medicinal product to prove its 
quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant. 
Established in 1989-1991 
Revised in 2005 and became ASMF (Active Substance Master File) after 
implementation of CTD in EU 
Applicable only to active substances 
Has been divided into 2 parts 
Applicant Part (Open) 
ASM Restricted Part (Closed / Confidential)
European Master File 
The DMF contains information which includes valuable know-how which should be kept confidential 
and submitted to the authorities only. Therefore, it should be divided into 2 parts – an applicant’s 
part and an ASM Restricted Part. The applicant’s part of a DMF is provided by the ASM (Active 
Substance Manufacturer) to the applicant directly and becomes part of the application for 
marketing authorization. Both the applicant’s part and the ASM Restricted Part of the DMF are 
submitted to the authorities. 
Applicant’s part of a DMF – opening part 
The applicant must be supplied by the ASM with sufficient information to be able to take 
responsibility for an evaluation of the suitability of the active substance specification to control 
the quality of the substance. This normally includes a brief outline of the manufacturing method, 
information on potential impurities originating from the manufacturing method, from the isolation 
procedure (natural products) or from degradation and, where applicable, information on the 
toxicity of specific impurities. 
ASM Restricted Part of DMF – closing part 
Detailed information on the individual steps of the manufacturing method such as reaction 
conditions, temperature, validation and evaluation data for certain critical steps of the 
manufacturing method, etc. and on quality control during manufacture may contain valuable 
know-how. Such information may therefore be supplied to the authorities only. 
16
EU: Documenting Quality: 
4 Options 
In Europe there are four ways to document the quality of the drug 
substance for the purpose of marketing authorization: 
Certificate of Suitability of the pharmacopoeia monograph (CEP) 
Full details of manufacture (according to CTD Module 3 - Quality of 
Drug Substance) 
European Active Substance Master File (ASMF; former Drug Master File, 
DMF) 
Other evidence of suitability of the pharmacopoeial monograph
Generic Drug Approval: Act 505 (j) 
Brand Name Drug Generic Drug 
NDA Requirements ANDA Requirements 
1. Chemistry 1. Chemistry 
2. Manufacturing 2. Manufacturing 
3. Controls 3. Controls 
4. Labeling 4. Labeling 
5. Testing 5. Testing 
6. Animal Studies 
7. Clinical Studies 6. Bioequivalence 
8. Bioavailability
INTRODUCTION 
A Drug Master File (DMF) is a set of documents that provides detailed information 
concerning facility protocols and procedures used in the manufacturing, packaging and 
storing of pharmaceuticals. 
A Drug Master File (DMF) is a submission to the FDA of information, usually 
concerning the Chemistry, Manufacturing and Controls (CMC) of a component of a 
drug product, to permit the FDA to review this information. 
 Drug product information or other non-CMC information may be filed in a DMF. 
Generally DMFs have two parts: 
(1) Applicant’s part : which contain non-confidential information that the license-holder 
needs to assess for the marketing. 
(2)Restricted part: which contains confidential information about the manufacturing 
procedure that only needs to be disclosed to the authorities
Drug Master file Process 
Two copies of the Drug Master File with one signed original of the covering letter and other necessary documents are send to the FDA’s 
Central Drug Evaluation and Research (CDRL). [1] 
The Drug Master File staff will audit the non-technical information for completeness and adequacy for submission. If the key elements are 
missing, the staff will contact the proposed holder to try to obtain the necessary documents in order to file the DMF. 
Once the DMFs are determined to be acceptable for filing, the document room staff assigns a DMF number and a letter is sent to the 
contact person listed in the DMF. 
All DMF submitted in CTD format is accepted by any authorities.
WHO MUST FILE DMF? 
NOBODY 
There is no legal or regulatory requirement to file a DMF. A DMF 
may be filed to provide Chemistry, Manufacturing and Controls 
(CMC) information that the FDA reviews. 
It is only for Maintain confidentiality of proprietary information (e.g., 
Manufacturing procedure, key ingredients, etc.) for the holder
EU ASMF Structure: CTD 
In EU, ASMF must be submitted in different sections in CTD modules 
Module 1: Contains administrative and prescribing information (administrative information 
is only required for an ASMF) 
Module 2: Contains common overall summaries (QOS) of an “Applicant’s part” (open 
part) and “Restricted part” (close part). It is nothing but summary of the information 
provided in module 3. 
Module 3: Contains all Quality information. It contains applicant’s part and restricted part. 
Applicant’s Part contains information required for marketing authorization. The Restricted 
Part contains information that is extremely confidential for the ASMF holder and can share 
with the health authority only.
Drug Master File or DMF is a document prepared by a pharmaceutical 
manufacturer and submitted solely at its discretion to the appropriate 
regulatory authority in the intended drug market. 
There is no regulatory requirement to file a DMF. However, the document 
provides the regulatory authority with confidential, detailed information about 
facilities, processes, or articles used in the manufacturing, processing, packaging, 
and storing of one or more human drugs. 
Typically, a DMF is filed when two or more firms work in partnership on 
developing or manufacturing a drug product. 
The DMF filing allows a firm to protect its intellectual property from its partner 
while complying with regulatory requirements for disclosure of processing 
details.
Drug Master File (DMF) is a document containing complete information on an 
Active Pharmaceutical Ingredient (API) or finished drug dosage form. An Active Substance 
Master File (ASMF)is the currently recognised term in Europe, formerly known as 
European Drug Master File (EDMF) or a US-Drug Master file (US-DMF) in the United 
States. 
The DMF contains factual and complete information on a drug product's chemistry, 
manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any 
human drug product. 
A.GENERAL INFORMATION 
1. General properties 2. Structure 3. Nomenclature 
B. MANUFACTURE 1. Manufacture(s). 2. Description of Manufacturing Process and 
Process Control. a) Flow Chart of Manufacturing Process b) Synthetic Route of 
Manufacturing Process c) Manufacturing Method. 3. Control of Material a) List of Materials. 
b) Specification and routine tests of the Raw Materials. 4. Control of Critical Steps and 
Intermediates. a) Critical Steps. b) Process Validation and/or evalution. 5. Specifications and 
Test method for the Intermediates. 6. Manufacturing Process Development.
C. CHARACTERISATION 1. Elucidation of Structure and other characteristics. a) 
Elemental Analysis b) IR Spectrum of Drug Substance. c) NMR Spectrum of Drug 
Substance. d) Mass Spectrum of Drug Substance. e) U.V. Spectrum of Drug Substance. f) 
X-Ray Diffraction. g) Thermal Analysis. h) Comprehensive Illustration. 
2. Impurities a) Sources of Potential Impurities. b) Types of impurities. c) Test Procedure 
for determining impurities. 
D. CONTROL OF DRUG SUBSTANCES 1. Specifications 2. Analytical procedure (STP) 
3. Validation of Analytical procedure 4. Batch Analysis a) Description of Batches b) 
Certificate of Analysis 5. Justification of Specification
E. REFERENCE STANDARDS OF MATERIAL 
F. CONTAINER CLOSURE SYSTEM 
G. STABILITY 1. Stability summary and Conclusions 2. Post-Approval Stability protocol 
and Stability Commitment. 3. Stability data a) Accelerated Stability b) Long Term 
Stability Studies c) Forced Degradation Studies 
H. MATERIAL DATA SAFETY SHEET 
I. APPENDICES 1. FACILITIES AND EQUIPMENTS a) Building and Utilities 
2. EQUIPMENTS DESIGN AND LOCATION a. Equipment List b. Equipment Flow 
Chart 
3. ADVENTITIOUS AGENTS SAFETY EVALUATIONS STATEMENT OF COMMENT
(1) MANUFACTURING SECTION IN DMFS 
(a) Data of inputs (Raw materials/Packaging materials) 
and Sources 
 List all RMs and PMs with sources 
 Identify Key Starting Materials (KSMs) 
 Complex materials do not qualify as KSMs 
(b) Manufacturing Process details 
 Synthetic scheme 
 Process flow diagram 
 Detailed Process write up 
10/21/2014 
DR ANTHONY
FOLLOWING GENERAL POINTS INCLUDED IN TYPE 
II DMFS 
1. Manufacturing Section 
2. Quality Controls 
a. Input (Raw/Packaging Materials) 
b. Intermediates and In-process 
c. Finished Drug Substance 
3. Validations 
4. Stability data 
5. Impurities 
6. Packaging and labeling 
10/21/2014 
DR ANTHONY
10/21/2014 
(2) QUALITY CONTROLS’ SECTION IN DMFS 
Objective: To ensure quality at every stage of 
processes. 
Gradual increase in checks as the process progresses. 
Specification and test methods. 
Complete analytical data of study batches. 
Sampling procedures adopted. 
Analytical Reference Standard (ARS). 
Test batches vs. ARS. 
DR ANTHONY
NMR
(3) ANALYTICAL VALIDATIONS 
 Done accordance to reference guidelines: ICH Q 2A and B. 
Validation of In-house methods. 
Validation of Pharmacopoeial methods. 
10/21/2014 
DR ANTHONY
(4) IMPURIRTIES’ SECTION 
10/21/2014 
Objective: To prove that quality obtained is by design of 
process, not by chance. 
Justification for limits applied. 
Assay/Impurities’ determination. 
Forced Degradation Studies. 
Three consecutive commercial scale batches. 
Accelerated studies. 
Long term studies. 
Study include all susceptible parameters. 
All validated methods. 
Labeled unidentified impurities. 
DR ANTHONY
(5) PACKING AND LABELING 
 Detailed description of complete packing configuration. 
 Food-grade certification of inner-most Packing Materials. 
 Stability sample packing must be identical. 
 Specification and Test methods for all Packing Materials. 
 Specimen label must be submitted. 
 Clear mention of recommended storage conditions. 
10/21/2014 
DR ANTHONY
REMEMBER 
REMEMBER 
 There is no legal or regulatory requirement to file a DMF. 
 The information contained in DMF may be used to support an 
- Investigational New Drug Application (IND), 
- New Drug Application (NDA), 
- Abbreviated New Drug Application (ANDA) 
- An Export Application 
 DMF is NOT a substitute for IND / NDA / ANDA or export application.
BUT REMEMBER THAT, 
 Most of the type III DMF holders are ISO (International Organization of 
Standardization) certified, but the rules for ISO and those of CDER are not 
always the same. The needs of the applicant should also be considered. 
 Responsibility for compatibility and safety of packaging components in 
finished drug product is the responsibility of the AUTHORISED 
PARTY(AP). 
 It is not the responsibility of DMF HOLDER. 
10/21/2014 
DR ANTHONY
10/21/2014 
DR ANTHONY 
To submit the data 
which is not covered in type I to IV DMF 
A holder 
must first submit 
a letter of intent 
to the drug master file staff 
FDA will then contact the holder 
to discuss the proposed submission
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE 
A. Letter of Authorization (LoA) to FDA: 
The letter of authorization should include the following: 
 The date. 
 Name of DMF holder. 
 DMF number. 
 Name of person(s) authorized to incorporate information in 
the DMF by reference. 
 Specific product(s) covered by the DMF. 
10/21/2014 
DR ANTHONY
 Section numbers and/or page numbers to be referenced. 
 Statement of commitment that the DMF is current and that the 
DMF holder will comply with the statements made in it. 
 Signature of authorizing official. 
10/21/2014 
 Typed name and title of official authorizing reference to the DMF. 
DR ANTHONY
LETTER OF AUTHORIZATION (LOA) 
10/21/2014 
DR ANTHONY 
US FDA 
Send a letter to remind 
holder obligations DMF HOLDER 
1 copy of LOA to the 
APPLICANT 
Send 2 copies of LOA 
to the FDA 
The applicant submits THIS copy of 
LOA in their Application.
A DMF IS NEVER APPROVED OR DISAPPROVED. 
 The agency will review information in a DMF only when an IND sponsor, an applicant 
for an NDA, ANDA, or Export Application, or another DMF holder incorporates material 
in the DMF by reference. 
 As noted, the incorporation by reference must be accompanied by a 
copy of the DMF holder's letter of authorization. 
10/21/2014 
DR ANTHONY 
DRUG MASTER FILE REVIEW:-
10/21/2014 
REVIEWER When reviewer receives an application (IND/NDA/ANDA) that 
references DMF 
Requests the DMF from 
the CDR (central document room) 
DR ANTHONY 
After getting DMF, the Reviewer 
starts the review procedure 
If Reviewer found any deficiency in 
the content of DMF, 
The APPLICANT is also notified but, the nature of the 
deficiencies is not communicated to the applicant. 
The DETAILED DEFICIENCIES 
are communicated to the holder. 
HOLDER should submit the REQUESTED 
INFORMATION to the DMF in response to 
the agency's deficiency letter along with 
transmittal letter having subject matter.
DMF SEARCH ENGINE 
CLICK HERE 
DMF search engine
Other DMF Systems
DMF - Canada 
Canada has 4 Types of DMFs 
Type 1: Used for Active Pharmaceutical Ingredients (APIs) 
Type II: used for packaging materials 
Type III: used for excipients 
Type IV: used for products 
Type I & 4 have two sections 
Sponsor's (Open) 
Restricted (Closed)
Principal Focus on APIs 
DMF: Japan
Japanese DMF Flow Chart
DMF: Australia 
In the case of an API used by a producer for a medicine 
who’s origin is a third party manufacturer, data about its 
fabrication, quality control and stability can be presented by 
a Drug Master File (DMF). 
The Europena style relavent for the procedure of a Active Substance Master File, adopted by 
Austrailia’s Therapeutic Goods Administration (TGA), are available on the TGA website. 
A DMF format used by the US (FDA) is acceptable if the DMF is prepared according to the 
Common Technical Document (CTD) format or the older European format if this is not available.
China 
Draft Guidance Issued September 2010 
Applicable to marketed drug products registered in China 
Not applicable to clinical investigational materials 
Does not address exported APIs or excipients manufactured in 
China 
Filings required for: 
API, Excipients and Auxiliary Materials (primary, product contact containers or packaging) 
SFDA to develop system to administer filings
China DMA Requirements 
Drug Product manufacturer shall have written agreement with identified 
suppliers 
Drug product manufacturer is primary responsible entity for product 
quality 
Filings will be reviewed in context of drug product filing review, not 
separately 
Permit traceability of constituents and components of drug product 
• Filings to remain confidential
Global DMF Trends 
Not Yet Harmonized: 
US FDA: 2 copies of each Type II DMF u sing CTD format, but not in CTD module form. FDA format combines 
Modules 2 & 3 as there is no Applicant vs Restricted part. 
FDA moving towards eCTD applications 
EU: has separate portions for Modules 2 & 3 (Applicant / Restricted), but some countries in EU have different 
requirements 
EU wants electronic format but there are several formats; some countries still require paper 
Overhead: DMFs often run in excess of 1,000 pages. Storage and 
care of them can be a major burden.
Global DMF Challenges 
Open or Closed? 
CTD, eCTD 
Major advantages of a DMF system for Brasil? 
Major disadvantages of a DMF system for Brasil?
To take full advantage of Chemical Web content, it is 
essential 
to use several Software:Winzip,Chemscape 
Chime, Shockwave, 
Adobe Acrobat, Cosmo Player, Web Lab Viewer, 
Paint Shop Pro, Rasmol, ChemOffice, Quick Time,et
THANK YOU! 
DR ANTHONY CRASTO 
amcrasto@gmail.com 
http://newdrugapprovals.org/

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DMF by Anthony Crasto

  • 1. What is a Drug Master File? DR ANTHONY MELVIN CRASTO An introduction with case study of an API 1
  • 2.  LEADS:  1. Introduction to DMFs  2. Drug master file process  3. Drug master file format  4. Drug Master File contents 4.1 Submission of DMF 4.2 Authorization to refer to a drug master file 4.2.1 Format for Letter of authorization to review DMF 4.3. Processing and reviewing policies 4.4. Changes in DMFs 4.5. Closure of a drug master file 4.6. Retiring DMFs  5.Electronic Filing of DMFs and CTD  6. Changes in DMF system:  7.Application  8. Difference in European DMFS compare to us DMFs  9. European DMFs  10. Difference in European DMFS compare to US DMFs  11. Case study  12. References LEAD POINTS
  • 3. Executive Summary: Drug Master Files Closed DMFs: The FDA Way Mixed ASMFs: The European Way Harmonizing: the eCTD challenge Global Trends: The Future of DMFs Questions Agenda
  • 4. 10/21/2014 2) Drug product  Manufacturing procedures and controls for finished dosage forms DR ANTHONY Submitted in an IND, NDA, ANDA, or Export Application. If cannot be submitted in an IND, NDA, ANDA, or Export Application. Submitted in a DMF.
  • 5. Drug Submissions: US, Canada, EU TYPES OF DRUG SUBMISSIONS: US, Canada, EU USA New Drug Application (NDA), for new drugs Accelerated New Drug Application (ANDA)-for generics Biologic License Application (BLA), for biologic Canada New Drug Submission (NDS) for both ― drugs and biologic products EU Marketing Authorization Application (MAA)―via the Centralized Procedure for eligible products. For other products, via the decentralized, mutual recognition or national authorization are applicable.
  • 6. Role of DMFs Supporting documents for the registration / approval of drug products In the Chemistry, Manufacturing and Controls (CMC) sections of the drug submission, the DMF documents the drugs identity, purity, strength and quality. Protect Proprietary and Confidential Information
  • 7. DMFs Globally Highly Regulated Markets (Drug Master Files used to support approval process) United States: Canada: Australia Japan Europe: China is developing its own DMF system Nearly Regulated Markets (Technical Package / Registration Dossier) Brazil Russia South Africa Less Regulated Markets (No Drug Master Files used in registration process) India and many others
  • 8. Drug Master Files: USA 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 drugs. There is no legal or regulatory requirement to file a DMF. A DMF may be filed to provide CMC information that the FDA reviews instead of including this information in the Application (IND, NDA, ANDA). A DMF is neither approved nor disapproved by the FDA. It is provided for in 21 CFR 314.420 (Code of Federal Regulations)
  • 9. The US DMF System “Closed”
  • 10. DMF – US: Important Facts DMFs are Confidential (Closed) DMF Stakeholders DMF Holder: Company or Person who submits the DMF Applicant: Company or person who references the DMF in an application or another DMF Information contained in a DMF may be used to : Support an Investigational New Drug Application (IND)) Support a New Drug Application(NDA) Support an Abbreviated New Drug Application (ANDA) Support another DMF Support an Export Application Support amendments and supplements to any of these. 10
  • 11. How the US DMF System Works Filing the DMF Holder sends two copies of the DMF to FDA DMF is reviewed for administrative purposes only by Central Document Room staff DMF entered into database, assigned a number and acknowledgment letter sent to holder A DMF is neither approved or disapproved Accessing the DMF: Letter of Authorization (LOA)
  • 12. The DMF will be reviewed only when it is referenced in an Application or another DMF The Holder must submit a two copies of the LOA to the DMF, plus a copy to the Applicant The Applicant submits a copy of the LOA in their Application The LOA is the only mechanism to trigger a review of the DMF by the FDA DMF Review Procedure The DMF is reviewed only if referenced by an Applicant or another DMF If the reviewer finds deficiencies in the DMF, the deficiencies are detailed in a letter to the Holder The Applicant will be notified that deficiencies exist, but the nature of the deficiencies are not communicated to the Applicant
  • 13. US DMFs - Types In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application(ANDA), another DMF, or an Export Application. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel No longer accepted by the FDA (as of January 2000) Type II – Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product Type III – Packaging Type IV – Excipients, Colorant, Flavor, Essence, or Material Used in Their Preparation Type V – FDA Accepted Reference Information Used for sterile manufacturing plants and contract 13 facilities for biotech products
  • 14. The EU DMF (ASTM) System “Open & Closed”
  • 15. EU DMF (EDMF or ASMF) The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant. Established in 1989-1991 Revised in 2005 and became ASMF (Active Substance Master File) after implementation of CTD in EU Applicable only to active substances Has been divided into 2 parts Applicant Part (Open) ASM Restricted Part (Closed / Confidential)
  • 16. European Master File The DMF contains information which includes valuable know-how which should be kept confidential and submitted to the authorities only. Therefore, it should be divided into 2 parts – an applicant’s part and an ASM Restricted Part. The applicant’s part of a DMF is provided by the ASM (Active Substance Manufacturer) to the applicant directly and becomes part of the application for marketing authorization. Both the applicant’s part and the ASM Restricted Part of the DMF are submitted to the authorities. Applicant’s part of a DMF – opening part The applicant must be supplied by the ASM with sufficient information to be able to take responsibility for an evaluation of the suitability of the active substance specification to control the quality of the substance. This normally includes a brief outline of the manufacturing method, information on potential impurities originating from the manufacturing method, from the isolation procedure (natural products) or from degradation and, where applicable, information on the toxicity of specific impurities. ASM Restricted Part of DMF – closing part Detailed information on the individual steps of the manufacturing method such as reaction conditions, temperature, validation and evaluation data for certain critical steps of the manufacturing method, etc. and on quality control during manufacture may contain valuable know-how. Such information may therefore be supplied to the authorities only. 16
  • 17. EU: Documenting Quality: 4 Options In Europe there are four ways to document the quality of the drug substance for the purpose of marketing authorization: Certificate of Suitability of the pharmacopoeia monograph (CEP) Full details of manufacture (according to CTD Module 3 - Quality of Drug Substance) European Active Substance Master File (ASMF; former Drug Master File, DMF) Other evidence of suitability of the pharmacopoeial monograph
  • 18. Generic Drug Approval: Act 505 (j) Brand Name Drug Generic Drug NDA Requirements ANDA Requirements 1. Chemistry 1. Chemistry 2. Manufacturing 2. Manufacturing 3. Controls 3. Controls 4. Labeling 4. Labeling 5. Testing 5. Testing 6. Animal Studies 7. Clinical Studies 6. Bioequivalence 8. Bioavailability
  • 19. INTRODUCTION A Drug Master File (DMF) is a set of documents that provides detailed information concerning facility protocols and procedures used in the manufacturing, packaging and storing of pharmaceuticals. A Drug Master File (DMF) is a submission to the FDA of information, usually concerning the Chemistry, Manufacturing and Controls (CMC) of a component of a drug product, to permit the FDA to review this information.  Drug product information or other non-CMC information may be filed in a DMF. Generally DMFs have two parts: (1) Applicant’s part : which contain non-confidential information that the license-holder needs to assess for the marketing. (2)Restricted part: which contains confidential information about the manufacturing procedure that only needs to be disclosed to the authorities
  • 20. Drug Master file Process Two copies of the Drug Master File with one signed original of the covering letter and other necessary documents are send to the FDA’s Central Drug Evaluation and Research (CDRL). [1] The Drug Master File staff will audit the non-technical information for completeness and adequacy for submission. If the key elements are missing, the staff will contact the proposed holder to try to obtain the necessary documents in order to file the DMF. Once the DMFs are determined to be acceptable for filing, the document room staff assigns a DMF number and a letter is sent to the contact person listed in the DMF. All DMF submitted in CTD format is accepted by any authorities.
  • 21. WHO MUST FILE DMF? NOBODY There is no legal or regulatory requirement to file a DMF. A DMF may be filed to provide Chemistry, Manufacturing and Controls (CMC) information that the FDA reviews. It is only for Maintain confidentiality of proprietary information (e.g., Manufacturing procedure, key ingredients, etc.) for the holder
  • 22. EU ASMF Structure: CTD In EU, ASMF must be submitted in different sections in CTD modules Module 1: Contains administrative and prescribing information (administrative information is only required for an ASMF) Module 2: Contains common overall summaries (QOS) of an “Applicant’s part” (open part) and “Restricted part” (close part). It is nothing but summary of the information provided in module 3. Module 3: Contains all Quality information. It contains applicant’s part and restricted part. Applicant’s Part contains information required for marketing authorization. The Restricted Part contains information that is extremely confidential for the ASMF holder and can share with the health authority only.
  • 23. Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.
  • 24. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. An Active Substance Master File (ASMF)is the currently recognised term in Europe, formerly known as European Drug Master File (EDMF) or a US-Drug Master file (US-DMF) in the United States. The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. A.GENERAL INFORMATION 1. General properties 2. Structure 3. Nomenclature B. MANUFACTURE 1. Manufacture(s). 2. Description of Manufacturing Process and Process Control. a) Flow Chart of Manufacturing Process b) Synthetic Route of Manufacturing Process c) Manufacturing Method. 3. Control of Material a) List of Materials. b) Specification and routine tests of the Raw Materials. 4. Control of Critical Steps and Intermediates. a) Critical Steps. b) Process Validation and/or evalution. 5. Specifications and Test method for the Intermediates. 6. Manufacturing Process Development.
  • 25. C. CHARACTERISATION 1. Elucidation of Structure and other characteristics. a) Elemental Analysis b) IR Spectrum of Drug Substance. c) NMR Spectrum of Drug Substance. d) Mass Spectrum of Drug Substance. e) U.V. Spectrum of Drug Substance. f) X-Ray Diffraction. g) Thermal Analysis. h) Comprehensive Illustration. 2. Impurities a) Sources of Potential Impurities. b) Types of impurities. c) Test Procedure for determining impurities. D. CONTROL OF DRUG SUBSTANCES 1. Specifications 2. Analytical procedure (STP) 3. Validation of Analytical procedure 4. Batch Analysis a) Description of Batches b) Certificate of Analysis 5. Justification of Specification
  • 26. E. REFERENCE STANDARDS OF MATERIAL F. CONTAINER CLOSURE SYSTEM G. STABILITY 1. Stability summary and Conclusions 2. Post-Approval Stability protocol and Stability Commitment. 3. Stability data a) Accelerated Stability b) Long Term Stability Studies c) Forced Degradation Studies H. MATERIAL DATA SAFETY SHEET I. APPENDICES 1. FACILITIES AND EQUIPMENTS a) Building and Utilities 2. EQUIPMENTS DESIGN AND LOCATION a. Equipment List b. Equipment Flow Chart 3. ADVENTITIOUS AGENTS SAFETY EVALUATIONS STATEMENT OF COMMENT
  • 27. (1) MANUFACTURING SECTION IN DMFS (a) Data of inputs (Raw materials/Packaging materials) and Sources  List all RMs and PMs with sources  Identify Key Starting Materials (KSMs)  Complex materials do not qualify as KSMs (b) Manufacturing Process details  Synthetic scheme  Process flow diagram  Detailed Process write up 10/21/2014 DR ANTHONY
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  • 33. FOLLOWING GENERAL POINTS INCLUDED IN TYPE II DMFS 1. Manufacturing Section 2. Quality Controls a. Input (Raw/Packaging Materials) b. Intermediates and In-process c. Finished Drug Substance 3. Validations 4. Stability data 5. Impurities 6. Packaging and labeling 10/21/2014 DR ANTHONY
  • 34. 10/21/2014 (2) QUALITY CONTROLS’ SECTION IN DMFS Objective: To ensure quality at every stage of processes. Gradual increase in checks as the process progresses. Specification and test methods. Complete analytical data of study batches. Sampling procedures adopted. Analytical Reference Standard (ARS). Test batches vs. ARS. DR ANTHONY
  • 35. NMR
  • 36. (3) ANALYTICAL VALIDATIONS  Done accordance to reference guidelines: ICH Q 2A and B. Validation of In-house methods. Validation of Pharmacopoeial methods. 10/21/2014 DR ANTHONY
  • 37. (4) IMPURIRTIES’ SECTION 10/21/2014 Objective: To prove that quality obtained is by design of process, not by chance. Justification for limits applied. Assay/Impurities’ determination. Forced Degradation Studies. Three consecutive commercial scale batches. Accelerated studies. Long term studies. Study include all susceptible parameters. All validated methods. Labeled unidentified impurities. DR ANTHONY
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  • 39. (5) PACKING AND LABELING  Detailed description of complete packing configuration.  Food-grade certification of inner-most Packing Materials.  Stability sample packing must be identical.  Specification and Test methods for all Packing Materials.  Specimen label must be submitted.  Clear mention of recommended storage conditions. 10/21/2014 DR ANTHONY
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  • 41. REMEMBER REMEMBER  There is no legal or regulatory requirement to file a DMF.  The information contained in DMF may be used to support an - Investigational New Drug Application (IND), - New Drug Application (NDA), - Abbreviated New Drug Application (ANDA) - An Export Application  DMF is NOT a substitute for IND / NDA / ANDA or export application.
  • 42. BUT REMEMBER THAT,  Most of the type III DMF holders are ISO (International Organization of Standardization) certified, but the rules for ISO and those of CDER are not always the same. The needs of the applicant should also be considered.  Responsibility for compatibility and safety of packaging components in finished drug product is the responsibility of the AUTHORISED PARTY(AP).  It is not the responsibility of DMF HOLDER. 10/21/2014 DR ANTHONY
  • 43. 10/21/2014 DR ANTHONY To submit the data which is not covered in type I to IV DMF A holder must first submit a letter of intent to the drug master file staff FDA will then contact the holder to discuss the proposed submission
  • 44. V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE A. Letter of Authorization (LoA) to FDA: The letter of authorization should include the following:  The date.  Name of DMF holder.  DMF number.  Name of person(s) authorized to incorporate information in the DMF by reference.  Specific product(s) covered by the DMF. 10/21/2014 DR ANTHONY
  • 45.  Section numbers and/or page numbers to be referenced.  Statement of commitment that the DMF is current and that the DMF holder will comply with the statements made in it.  Signature of authorizing official. 10/21/2014  Typed name and title of official authorizing reference to the DMF. DR ANTHONY
  • 46. LETTER OF AUTHORIZATION (LOA) 10/21/2014 DR ANTHONY US FDA Send a letter to remind holder obligations DMF HOLDER 1 copy of LOA to the APPLICANT Send 2 copies of LOA to the FDA The applicant submits THIS copy of LOA in their Application.
  • 47. A DMF IS NEVER APPROVED OR DISAPPROVED.  The agency will review information in a DMF only when an IND sponsor, an applicant for an NDA, ANDA, or Export Application, or another DMF holder incorporates material in the DMF by reference.  As noted, the incorporation by reference must be accompanied by a copy of the DMF holder's letter of authorization. 10/21/2014 DR ANTHONY DRUG MASTER FILE REVIEW:-
  • 48. 10/21/2014 REVIEWER When reviewer receives an application (IND/NDA/ANDA) that references DMF Requests the DMF from the CDR (central document room) DR ANTHONY After getting DMF, the Reviewer starts the review procedure If Reviewer found any deficiency in the content of DMF, The APPLICANT is also notified but, the nature of the deficiencies is not communicated to the applicant. The DETAILED DEFICIENCIES are communicated to the holder. HOLDER should submit the REQUESTED INFORMATION to the DMF in response to the agency's deficiency letter along with transmittal letter having subject matter.
  • 49. DMF SEARCH ENGINE CLICK HERE DMF search engine
  • 51. DMF - Canada Canada has 4 Types of DMFs Type 1: Used for Active Pharmaceutical Ingredients (APIs) Type II: used for packaging materials Type III: used for excipients Type IV: used for products Type I & 4 have two sections Sponsor's (Open) Restricted (Closed)
  • 52. Principal Focus on APIs DMF: Japan
  • 54. DMF: Australia In the case of an API used by a producer for a medicine who’s origin is a third party manufacturer, data about its fabrication, quality control and stability can be presented by a Drug Master File (DMF). The Europena style relavent for the procedure of a Active Substance Master File, adopted by Austrailia’s Therapeutic Goods Administration (TGA), are available on the TGA website. A DMF format used by the US (FDA) is acceptable if the DMF is prepared according to the Common Technical Document (CTD) format or the older European format if this is not available.
  • 55. China Draft Guidance Issued September 2010 Applicable to marketed drug products registered in China Not applicable to clinical investigational materials Does not address exported APIs or excipients manufactured in China Filings required for: API, Excipients and Auxiliary Materials (primary, product contact containers or packaging) SFDA to develop system to administer filings
  • 56. China DMA Requirements Drug Product manufacturer shall have written agreement with identified suppliers Drug product manufacturer is primary responsible entity for product quality Filings will be reviewed in context of drug product filing review, not separately Permit traceability of constituents and components of drug product • Filings to remain confidential
  • 57. Global DMF Trends Not Yet Harmonized: US FDA: 2 copies of each Type II DMF u sing CTD format, but not in CTD module form. FDA format combines Modules 2 & 3 as there is no Applicant vs Restricted part. FDA moving towards eCTD applications EU: has separate portions for Modules 2 & 3 (Applicant / Restricted), but some countries in EU have different requirements EU wants electronic format but there are several formats; some countries still require paper Overhead: DMFs often run in excess of 1,000 pages. Storage and care of them can be a major burden.
  • 58. Global DMF Challenges Open or Closed? CTD, eCTD Major advantages of a DMF system for Brasil? Major disadvantages of a DMF system for Brasil?
  • 59. To take full advantage of Chemical Web content, it is essential to use several Software:Winzip,Chemscape Chime, Shockwave, Adobe Acrobat, Cosmo Player, Web Lab Viewer, Paint Shop Pro, Rasmol, ChemOffice, Quick Time,et
  • 60. THANK YOU! DR ANTHONY CRASTO amcrasto@gmail.com http://newdrugapprovals.org/

Editor's Notes

  1. CMC-Chemistry, Manufacturing & Controls