The quality standards of the Ph. Eur. are essential for ensuring the quality of all medicines available in Europe and beyond. These standards are usually composed of a documentary standard (monograph or general method) and physical standards (reference standards). Understanding the links between them is essential for the appropriate application of the Ph. Eur. quality standards.
In this module, you will learn about chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters. It covers the basis of their scientific establishment, provides additional information on their use and addresses requirements of GMP inspectors on reference standards. It also provides practical tips on how best to handle them and points to note when ordering, and addresses questions that you may have as a user.
The recording includes a Q&A session.
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Target audience
The module is of interest to all individuals involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for anyone looking to build a solid foundation knowledge of both the Ph. Eur. and the CEP Procedure, such as recent graduates or early-career professionals.
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Duration: 1 hour, 50 minutes
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- Ph. Eur. Reference Standards: establishment and use by Bart Blanchaert
- What GMP inspectors expect on Reference Standards by Oisín Daly
- Handling-dispatch - Where to find useful information and other practicalities by Maryline Clauzel
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