TitlePrioritizing the monitoring of the quality of the production process of medicines
ContactR. (Rabab) Chrifou
L. (Liset) van Dijk
Project descriptionOnce medicines are on the market, it is important to guarantee the quality of it manufacturing process. This is done through the Good Manufacturing Practice (GMP). The Health Care Inspectorate (IGZ) regulates the process. The purpose of this research is to gain insight into the major risk areas within the manufacturing process of medicines Various qualitative research methods are used to answer the research question, namely document research, and expert consultation, interviews with IGZ inspectors and analysis of IGZ notifications and complaints. Better regulation of risks may lead to more efficient and effective regulation.
SubsidiserZonMw; Academische Werkplaats Toezicht