SPARK Educational Forum: GMP Considerations

Prof. Petra Reinke, BCRT

Marco Climaco, Clue

Good manufacturing Practice (GMP) describes a set of principles and procedures aiming at the consistent production and control of medicines and healthcare goods. To guarantee patient safety all steps of production from the starting materials, premises and equipment to the training and personal hygiene of staff have to be covered. Therefore, systems have to provide documented proof that correct procedures are followed at each step in the manufacturing process. Prof. Petra Reinke and Marco Climaco will give an overview on the regulatory aspects and point out the most important GMP considerations.