322574 VU Regulatory Affairs and Compliance in Good Manufacturing Practices (GMP) - M7/M14 (2025W)

The pharmaceutical industry is subject to strict regulatory standards, such as Good Manufacturing Practice (GMP), which ensure that medicines are produced under the highest quality standards. This lecture exercise provides an in-depth look at the key elements of GMP.

The goal of the course is to develop a solid understanding of the fundamentals and gain a holistic understanding of quality and compliance management in the pharmaceutical industry.

Good Manufacturing Practice (GMP) ensures that pharmaceutical products are consistently produced and controlled according to strict quality standards. It covers all areas of production – from raw materials to equipment and facilities, as well as the training and personal hygiene of staff. A key component of GMP is documentation, which provides evidence that correct procedures are consistently followed at every step of the manufacturing process. The overarching goal is to minimize risks and ensure that high-quality and safe products are always brought to market.