323112 VU Key elements of Good Manufacturing Practice (GMP) - MPS5 (2020S)

Pharmaceutical industry follows strict regulatory standards as Good Manufacturing Practice. This lecture covers the key elements of GMP to understand the big picture of pharma quality and compliance management.

Good Manufacturing Practice (GMP) ensures that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process. The aim to minimize risks as low as possible and to provide every time high quality and safe products on the market.

Key elements:
1) GMP and historical developments
2) GMP regulations (EU, US, global) in comparison to national law
3) Production and Clean Room Design
4) Documentation, Validation and Qualification
5) Pharmaceutical Quality Management