Master in Regulation and Evaluation of Medicines and Health Products

Quality of Medicines II



Learning outcomes

Students must acquire and consolidate all aspects associated to medicines development, the process for quality characterization, parameters to determine and the requirements related to quality assurance of processes and developed products, including the Good Laboratory Practices (GLP). By the end of the discipline students must have acquired comptetences for, in relation to experimental medicines and medicines for introduction into the market i) evaluate a quality dossier ii) manage production iii) establish quality characterization iv) identify the need for following GLPs v) to get familiar with the principles and to apply GLPs.


Introduction to Quality Management of Medicines
Rules/Guidance ISO 9001:2000; Certification
Statistical Control of Processes
OECD Good Laboratories Practices
Quality Control- Lab techniques
Licencing of Radiopharmaceuticals
GMPs, Good Practices of Distribution and Good Pharmacy Practices
Directives 2003194
European Guide of Good Manufactures Practices
European inspection procedures GMPs Quality by design/risk Management/PAT: new contexto of GMPs implementation.