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 a physical standard (reference standards) necessary for apply its application. Understanding the links between them is essential for the appropriate application of the Ph. Eur. quality standards.
In this module, you learn about chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters. It covers the basis of their scientific establishment, provide additional information on their use and address 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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This module is of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for those looking to build a solid foundation knowledge of both the Ph. Eur. and the Certification procedure, for example, newly graduated or early-career professionals.
Duration: 2 hours.
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- Ph. Eur. Reference Standards: establishment and use by Bart Blanchaert
- Reference Standards for General Chapters by Jochen Pauwels
- What GMP inspectors expect on RS by Sotirios Paraschos
- Handling-dispatch - Where to find useful information and other practicalities by Pierre Leveau
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