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 the chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters. It will cover how they are scientifically established, provide additional information on their use and address requirements of GMP inspectors regarding reference standards. It will also provide practical tips on how best to handle them and points to note when ordering, and will address questions that you may have as a user.
The presentations will be followed by a live Q&A session.
Programme (subject to change):
10:00-10:40 Ph. Eur. Reference Standards: establishment and use
10:40-10:50 What GMP inspectors expect concerning RS
10:50-11:40 Handling, dispatch, where to find useful information and other practical aspects
11:40-12:10 Live Q&A Session
