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„GxP“ Information Course PDF Print

Instructors:

Dr. Jörg Schäffner, IDT Biologika GmbH (GMP/GDP)
Dr. Lisa Steinhauser, Showa Denko Europe GmbH (GLP/GCP)

Moderator:

Steffen Biernath, GMP Academy

 

Date: November 22, 2021

Time: 16:00-19:00 h

Location: online event

 

Outline:

GMP/GDP
The globally established systems of Good Manufacturing Practice (GMP) and Good
Distribution Practice (GDP) of medicinal products for human use serve to ensure the
safety, efficacy and quality of medicines.
A brief introduction to the world of pharmaceutical regulation in these areas covers the
main laws and ordinances in Germany, the EU and the USA. Questions about why such
regulations were created and how they develop are also answered. The terms and the
handling of the rules is not difficult and requires science and last but not least a healthy
portion of common sense.
The course introduces the essential regulations with focus on the rules of the EU and
gives an outline of the topics and requirements for pharmaceutical manufacturers and
sales organizations.

GLP/GCP
Good Laboratory Practice (GLP) is a quality management system that is used in certified
laboratories. It is necessary, among other things, for the analysis of drugs in the
development stage (animal (in vivo) and cell (in vitro) studies), but also for
environmental safety tests. In this part of the course, the 10 basic principles such as the
requirements for personnel, apparatus and measurement results are explained.
Good Clinical Practice (GCP) encompasses the ethical and scientific quality requirements
for conducting clinical trials on humans. After an overview of the different phases of
drug testing and approval, the most important terms and the content of the guideline
are explained. GCP is relevant for pharmaceutical companies and the contract research
laboratories and clinics involved.
A short introduction (45 minutes) to the pertinent GxP regulatory framework (GLP/GMP/GCP/GDP) will be given and in additional 45 minutes GxP examples for biologics from early stage drug development to post market will be presented.


 

 

 

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