Basic GMP

GMP (Good Manufacturing Practice) is a set of rules and standards that ensure medicinal products are manufactured consistently and safely. GMP supports quality, traceability, and patient safety.In this course, you will receive a thorough introduction to GMP and the EU rules governing the manufacture of medicinal products. You will gain a fundamental understanding of the requirements, responsibilities, and mindset needed to work in a GMP-regulated environment.You will be introduced to the life science industry and the journey a medicinal product takes to reach the market.You will explore the link between legal requirements, quality, and patient safety. We take an in-depth look at the EU GMP guidelines (EudraLex Volume 4).You will work with key topics such as:

• The Pharmaceutical Quality System
• Risk Management
• Requirements for Manufacturing
• Personnel
• Premises and Equipment
• Documentation

The course combines presentations, discussions, and practical exercises.You will also participate in an interactive GMP simulation game based on typical workplace situations. The game encourages engaging discussions and makes it easier to translate GMP principles into everyday practice.The course is delivered over two days and includes an overnight stay, providing time and space for reflection, deeper learning, and networking with fellow participants.

This significantly enhances your overall learning experience and maximizes the value of the course.

Your benefits

• You understand the fundamental principles of GMP and the structure of the EU GMP guidelines.
• You can work more confidently with documentation, quality and GMP requirements.
• You can apply a basic GMP mindset and contribute to ensuring the quality of medicines.

Your company's benefits

• Your employee has an understanding of GMP, quality, GMP-mindset and responsibility.
• Your employee works more consistently and correctly according to applicable regulations.
• Your employee contributes to improved quality and patient safety.