CTD, CEP and Active Substance Master File

CTD, CEP and Active Substance Master File

Prague, Czech Republic

Seminar Nr. 15219


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Boris Pimentel
Pi-Consulting, Switzerland
Cristian Sampaolesi
European Directorate for the Quality of Medicines (EDQM & Health Care), France
Wilhelm Schlumbohm
Berlin, Germany
Jan Smeets
DSM Sinochem Pharmaceuticals, The Netherlands


This education course is intended to provide guidance on the format, content and submission procedures for the pharmaceutical documentation of the quality of the drug substance for different types of dossiers, the CTD, the CEP and the European ASMF and the US-DMF. Furthermore, the impact of the new variations regulations will be discussed.

Participants will have the opportunity to choose 2 out of 4 parallel workshops:
Stability studies and establishing a retest date
Description of the manufacturing process
How to compile data for impurities and residual solvents
Questions and answers of the CEP procedure


In Europe there are four ways to document the quality of the drug substance for the purpose of marketing authorisation since 1992:
Certificate of Suitability of the pharmacopoeial 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

In the US, the quality of the drug substance can be documented as part of the CMC Dossier or in a US-DMF.


The education course is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations who want to become familiar with the different ways to document the quality of the drug substance for the purpose of marketing authorisation in Europe. Furthermore, the course will be of interest to personnel from Quality Units of the pharmaceutical and the API industry.


General Part

Dossier Requirements for the Drug Substance –
An Introduction
Chemical pharmaceutical documentation for active substance(s) – Regulatory requirements in EU, USA
Types of active substances – types of documentation
CTD Module 3, CEP and ASMF (former DMF)
CEP for a substance for TSE risk assessment

How to Compile an ASMF Using the CTD Format
Data in Module 3 Quality ‘Drug Substance’
Compilation of an ASMF
Compilation of the US-DMF
Regulations in Europe and the US
Compilation of an ASMF
Compilation of the US-DMF
Comparison ASMF / US-DMF

Requirements for the Certificate of Suitability
Regulatory basis: Resolution AP-CSP (99)4 of the Council of Europe
CEP Procedure
Content of the CEP dossier with practical examples
Administrative minor and major changes, 5 year’s revision

Special Part

Drug Substance - Setting Specifications
Definition of ‘specification’
ICH/CHMP guidelines
Pharmacopoeial tests and acceptance criteria
Specifications in API development
Criteria for the specification of impurities
Justification of specifications

Stability Data
CPMP/ICH Guidelines
Stability Summary and Conclusions, stability
Documentation of Stability Data
Necessity for documentation of raw data?

Description of the Manufacturing Process and Process Controls
Description of the manufacturing process
Definition of the API starting material
Process Controls
Special items for APIs manufactured by cell culture / fermentation

Impurities and Residual Solvents
CPMP/ICH Guidelines Impurities and Residual Solvents
Specifying Impurities
Classifying solvents, setting and proving limits
Justification of Specification

Regulatory Compliance

Handling of Variations/Changes in Europe and the US
New EU Variations Regulation and detailed
Types of Changes
Remaining problems of changes for the API Industry
Change system for APIs in EU
Change System for APIs in USA
New FDA initiatives to facilitate changes
Preferred options for Bulk Pharmaceutical Industry to solve post-approval change problems
How to handle variations in the ASMF and the CEP procedure

Comparison of CEP and ASMF Procedure
Advantages of the CEP procedure
Handling Changes
In which countries is the CEP being accepted?
Cost Considerations
Practical examples

Parallel Workshops

Please choose two out of four parallel workshops

Stability Studies and Establishing the Retest Date
Dr Jan Smeets

Description of the Manufacturing Process
Dr Wilhelm Schlumbohm

How to Compile Data for Impurities and
Residual Solvents
Dr Boris Pimentel

Questions and Answers of the CEP Procedure
Fiona McLeod

Important: In order to prepare the lectures and the workshops in an optimal way, please send your questions to special topics to Dr Gerhard Becker, email:
becker@concept-heidelberg.de. He will forward your questions to the responsible speaker. Thank you in advance for your cooperation.


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