Drug Master File Procedures in the EU, the US and Japan Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

Drug Master File Procedures in the EU, the US and Japan

Vienna, Austria

Course No 20623

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



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Marieke van Dalen, Aspen Oss B.V., The Netherlands
Dr Cornelia Nopitsch-Mai, Quality Assessor, Germany
Dr Wilhelm Schlumbohm, Berlin, Germany


This education course 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
Participants will have the opportunity to join one of two parallel workshops about
  1.  Description of the Active Substance manufacturing process
  2.  Managing changes in Drug Master Files


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 education course 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.

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.


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
Drug Master File Procedures in the US
  • How to file and use Drug Master Files in the US
  • The format and the content of the US Drug Master File
  • Specific points to consider for the US Drug Master File
  • GDUFA Question based review: some US specifics
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
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
Parallel Workshops
Please choose one out of two parallel workshops
  1. Description of the Active Substance manufacturing process
  2. Managing changes in Drug Master Files – Case Studies
Handling Changes in the US
  • What guidance to use
  • Types of changes in the US guidance and the procedures around it
  • How to classify a change in the US
  • Link to the FDA inspection program
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
Requirements of the Drug Master File Procedure in Japan
  • 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
Changes and Maintenance of Japanese Drug Master Files
  • Change procedures and communication with the Japanese authority
  • Types of changes
  • Notification of changes
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

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