This exam is open to any participant who has successfully completed the LVQ course GMP Manager or has similar knowledge and skills. The participant must have attended at least 80% of the 180 teaching units, worked on a practice project during this period and presented the results. To determine absenteeism, the presence is documented.

The curriculum of the LVQ course has been submitted to PersCert TÜV and has been approved by it.

• Written Examination (Multiple Choice)

In the examination the participants prove their knowledge in the following areas:

• Basics of Good Manufacturing Practice (GMP)
• Process management, organizational and leadership requirements
• Hygiene requirements in the manufacture of pharmaceuticals
• Requirements for buildings, installations and equipment
• Supplier management and warehouse requirements
• Production requirements
• Quality control
• Documentation and data integrity
• Risk management and continuous improvement
• Customer focus
• Auditing and inspection
• Good Clinical Practice (GCP)
• Development of a practical project, group work and presentation of results

The graduate of the course “GMP Manager with TÜV Certified Qualification” is able to introduce, maintain and further develop GMP systems according to the requirements.