Ph. Eur., USP and other Pharmacopoeias - Live Online Training
17/18 September 2024
Course No. 21336
Speakers
Dr. Raphael Bar
BR Consulting
Dr. Ulrich Rose
Straßburg
Dr. Bernd Renger
Bernd Renger Consulting
Note: All times mentioned are CEST.
Objectives
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, Ph. Eur. 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 Live Online Training will discuss these issues and provides support in order to successfully deal with compendial methods and their differences.
Background
Pharmaceutical companies have to follow Pharmacopoeia standards in order to meet regulatory requirements. However, there is no single Pharmacopoeia which can be applied in all regions. The US FDA may enforce USP monographs which then become mandatory whereas compliance with Ph. Eur. is mandatory in 39 member states and the European Union (EU) and is applied in over 100 countries worldwide. Moreover, also other Pharmacopoeias exist in the world like the Japanese (included in the PDG harmonisation process) , Chinese, Russian or Indian Pharmacopoeias.
But what are the differences and how to deal with quality standards and test methods if products are manufactured and released for different markets?
Target Group
This Live Online Training addresses employees and managers from Quality Control Labs. It also addresses colleagues working in Quality Assurance and Regulatory Affairs department.
Technical Requirements
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Seminar Programme as PDF