Live Online Training: Drug Master File Procedures in the EU, the US and Japan

29/30 September 2020

Course No. 18299



Dr. Wilhelm Schlumbohm

Dr. Wilhelm Schlumbohm

Marieke van Dalen

Marieke van Dalen

MARA Consultancy, The Netherlands


This Live Online Training is intended to provide guidance on the procedures for the European ASMF, the US-DMF and the Japanese DMF.
 You will get to know
  •  how to describe manufacturing processes
  •  how to compile data for drug substance stability, impurities and residual solvents
  •  which are the important points to consider for US-DMFs
  •  which are the requirements for Japanese DMFs
  •  how to handle changes in European, US- and Japanese DMFs
  •  which are the major differences and advantages of the ASMF and CEP procedure


Documentation of the drug substance quality is an integral part of any marketing authorisation application. In Europe the most common document for this purpose is the Active Substance Master File (ASMF) as long as the applicant has no Certificate of Suitability of the pharmacopoeial monograph (CEP). The European ASMF procedure differs significantly from the US-DMF procedure and for strategic reasons it is very important to take these differences into account. Moreover there are particular requirements for DMFs in Japan. For global acting companies it is a big challenge to handle the different procedures of compiling, submitting, changing and maintaining Drug Master Files in an efficient way.

Target Group

The Live Online Training is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations especially for Drug Master Files who want to become familiar with the different DMF procedures. Furthermore, the course will be of interest to personnel from Quality Units of the pharmaceutical and the API industry.

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Live Online Training: Drug Master File Procedures in the EU, the US and Japan

Seminar Programme as PDF

Programme 29 September 2020

09.00 – 09.15 h Introduction

09.15 – 10.00 h
The European Active Substance Master File
  • Procedure – An Introduction
  •  Regulatory background and Scope
  •  The revised ASMF guideline
  •  Open and closed parts – points to consider
  •  Comparison of ASMF and CEP procedure
10.00 – 10.15 h 
Q & A Session

10.15 – 10.45 h Break

10.45 – 11.30 h
Drug Master File Procedures in the US
  •  Types of Drug Master Files
  •  Drug Master Files under GDUFA
  •  Submissions of DMFs
  •  Holder obligations
  •  Maintenance of Drug Master Files
  •  US vs EU DMF – differences in the procedure
11.30 – 11.45 h 
Q & A Session

11.45 – 12.30 h
Handling Changes in the EU
  •  Why is there a need for changes
  •  Types of changes
  •  How to communicate with the MA holders and how to get feed back
  •  Differences between ASMF and CEP
  •  When to implement a specific change
  •  Version management of the ASMF
12.30 – 12.45 h
Q & A Session

12.45 – 14.00 h Break

14.00 – 14.45 h
Post Approval Changes in the US
  •  Post approval activities
  •  Reporting requirements to the FDA (CBE 0, CBE 30, Annual Report)
  •  Post approval commitments and post approval reporting requirements
  •  Risk evaluation and mitigation strategies (REMS)
14.45 – 15.00 h
Q & A Session

15.00 – 15.30 h Break

15.30 – 16.30 h
Description of the Active Substance Manufacturing Process
  • Regulatory basis - relevant guidelines
  • Description of the Active Substance Manufacturing process 
  • Active substance starting material
  • Critical steps in the synthesis
  • Process validation
16.30 – 16.45 h 
Q & A Session

Programme 30 September 2020

08.30 – 09.15 h
Comparison of the CEP and ASMF Procedure
  •  The certification scheme of the Ph.Eur.
  •  Advantages and disadvantages of the CEP procedure compared to the ASMF procedure
  •  Handling of variations in the CEP procedure
  •  Countries accepting CEPs
09.15 – 09.30 h 
Q & A Session

09.30 – 10.15 h
How to document Drug Substance Stability
  • Stability Guidelines
  • Stability Testing of new drug substances and drug products
  • Storage Conditions
  • Bracketing and Matrixing Designs
  • Stability data from new drug dosage forms
  • How to document evaluation of stability data
  • Optimising the submission
10.15 – 10.30 h 
Q & A Session

10.30 – 11.00 h Break

11.00 – 11.45 h
Residual Solvents and Impurities: Synthesis derived Impurities, Metals and genotoxic Impurities
  •  Guidelines
  •  Impact of the new guidelines ICH Q3D and ICH M7
  •  Sources of Impurities
  •  Setting and justification of specifications
  •  Residual solvents, solvent classes
  •  Content and scope of data – documentation requirements
  •  Frequent mistakes
11.45 – 12.00 h
Q & A Session

12.00 – 13.00 h Break

13.00 – 14.15 h
Requirements of the Drug Master File Procedure in Japan (Part 1 and 2)
  •  Regulatory procedures in Japan:
  •  Site accreditation
  •  GMP paper-based inspection
  •  Drug Master File
  •  Drug Master File format
  •  Specific points to consider for the J-DMF
  •  Communication with the Japanese authorities
14.15 – 14.30 h
Q & A Session

14.30 – 15.00 h  Break

15.00 – 16.00 h
Managing Changes in Drug Master Files – Case Studies

16.00 – 16.30 h
Final Q & A Session


This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more

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