GMP for Beginners
Understanding the importance of GMP
Im Auftrag der ECA Academy

The course is designed for people who have no or Little knowledge of GMP.

In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements. The relevant European GMP regulations define the following prerequisites:

Commisson directive 2003/94/EC
The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice ….

EudraLex Vol. 4 Good manufacturing practice (GMP) guidelines
2.9 Besides the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them…..

In practice, many members of staff are often unaware of the contents and meaning of the different GMP requirements from Europe and US and their consequences for product quality. During this course, speakers with long-standing experience in the training of employees introduce and explain the most important elements of a pharmaceutical GMP system in an easy-to-understand way.