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).For appropriate application of the quality standards, the links between them need to be understood.
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, 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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Duration: 2 hours.
Target audience
The 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.
Download the presentations
- Module 4: Chemical monographs and finished product RS by Bart Blanchaert
- Module 4: Reference Standards for General Chapters by Stefan Almeling
- Module 4: What GMP inspectors expect on RS by Sotirios Paraschos
- Module 4: Handling-dispatch - Where to find useful information and other practicalities by Pierre Leveau
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