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. In this context the consequences of the guidelines on Elemental Impurities (ICH Q3D) and genotoxic impurities (ICH M7) will be considered. Furthermore, the impact of the variations regulations will be discussed.
Participants will have the opportunity to choose 2 out of 3 parallel workshops:
Stability studies and establishing a retest date
Description of the manufacturing process
The CEP Procedure – do’s and don’ts
In Europe there are several ways to document the quality of the drug substance for the purpose of marketing authorisation:
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.
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
Requirements for the Certificate of Suitability
Regulatory basis: Resolution AP-CSP (99)4 of the Council of Europe
Content of the CEP dossier with practical examples
Administrative minor and major changes, 5-year’s revision
Pharmaceutical Impurities: Residual solvents, synthesis-derived and genotoxic impurities
CPMP-/ICH-Guidelines on Impurities and Residual Solvents
ICH M7 Guideline on genotoxic impurities
Classifying solvents, setting and proving limits
Justification of Specification
Stability Summary and Conclusions, stability commitment
Documentation of Stability Data
Necessity for documentation of raw data?
Scope and applicability of the ICH Q3D guideline
Similarities and differences with the EU-Metal Catalysts guideline
What is the link with the EP and USP monographs?
The classification system of heavy metals and metal catalysts in the guideline, thresholds.
Implications to the API industry – additional requirements – analytical work required –costs
What do authorities expect?
API Regulatory Starting Materials: how to defend their choice in a submission
Why is this such a hot topic
What guidelines to consider
How to define a suitable starting material
How to defend your choice in the submission
What is different for generics
Consequences of a redefinition
Comparison of the CEP and DMF Procedure
Advantages of the CEP procedure
In which countries is the CEP being accepted?
Variations/Changes and life cycle management: in the EU, US and rest of the world
Types and categories of API changes
EU: the variation regulation and CEP revisions
Handling API changes in the US
Handling API changes in Japan
Handling API changes outside these regions
Initiatives to facilitate changes
Registration requirements for APIs in emerging countries
General remarks on API registrations in Emerging Countries
Details of API registration in: China, Taiwan, India, CIS countries: Russia Belarus, Ukraine, Brazil, GCC countries
APIC Emerging Countries Interest Group
Stability Studies and Establishing the Retest Date - Dr Jan Smeets
Description of the Manufacturing Process - Dr Wilhelm Schlumbohm
The CEP Procedure – do’s and don’ts - Cristian Sampaolesi
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@example.com
He will forward your questions to the responsible speaker. Thank you in advance for your cooperation.