EDQM Virtual Training Programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
Individual monographs are the core texts of the Ph. Eur., covering active substances, excipients and also medicinal products. This module provides an overview of the general principles, explains the link between individual and general monographs and general chapters, and the structure of...
Learn more about the Ph. Eur. policy on impurity control.
Learn about chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters.
This module gives a general presentation of the CEP procedure. The background and scope of the CEP procedure is explained in detail, and a comparison with the Active Substance Master File (ASMF) procedure is made. The second part of the module provides tools and tips on how to read a CEP and...
The first part of this module explains how to build a good application for a new CEP and how to avoid deficiencies. The module is based on the top 10 most frequently asked questions after the initial evaluation of new CEP applications, along with expectations and recommendations on how to...
This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants receive information to facilitate efficient preparation for the inspection, in particular with regard to obligations/communications ahead of time. An...
Suggested viewing and reading
The EDQM recommends participants watch and read the pre-training materials listed below before joining a training module. The materials will help participants familiarise themselves with some basic concepts and topics which will not be covered in detail in the webinar sessions.
- European regulations for medicines: Place and role of the EDQM and the European Pharmacopoeia (Ph. Eur.) - Duration: 30 minutes
- General concepts in the European Pharmacopoeia - Duration: 30 minutes
- How to participate in the Elaboration of the European Pharmacopoeia - Duration: 20 minutes
- Find your way in Pharmeuropa, the Knowledge database & Ph. Eur. Online: Useful hints and other practicalities) - Duration: 25 minutes
- Ph. Eur. Reference Standards: General Aspects Duration: 20 minutes
- The Certification procedure: Fact sheet