It is important to understand the structure and the procedures of the different Pharmacopoeias. Some general chapters and the monographs of some widely used excipients have already been harmonised between the most important Pharmacopoeias, USP, EP and JP in the context of the Pharmacopoeial Discussion Group (PDG).
But for a large number of general methods differences still exist. Therefore some of the frequently asked questions are:
- How to use alternative procedures and interchangeable methods?
- What are the allowed exceptions to the obligation to perform all tests?
- How can multi-compendial testing strategies look like?
- How to prove equivalence?
In addition, PDG harmonisation does not include upcoming important pharmacopoeias like Indian and Chinese Pharmacopoeias.
This Education Course will discuss these issues and provides support in order to successfully deal with compendial methods and their differences.
For more information and registration visit: www.gmp-compliance.org