Objectives of Programme's Learning Outcomes

• Scientific skills
• Implement and independently carry out an experimental approach, validate a model by comparing its predications with experimental results, assess the limitations of the model's validity, and identify sources or error.
• Appropriately select measuring instruments, analyse and process the signal obtained
• Use basic mathematical tools
• Be a responsible researcher: - Know how to base their reasoning on data obtained from scientific literature. - Know how to integrate an ethical dimension in their reasoning. - Be loyal (to the facts, to the team, and to intellectual property). - Do not tamper with results. - Do not exploit the work of others. - Demonstrate experimental rigor.
• Professional integration skills
• Invest their knowledge and skills in professional scenarios
• Be in a hierarchical and professional environment, identify their skills and follow procedures, legislation, standards, among other security and safety measures

Learning Outcomes of UE

The objective of this course is to give a clear overview of the main quality standards used in the pharmaceutical industry: current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). We will study the basic principles common to those two quality standards and their specific applications.    
 

UE Content: description and pedagogical relevance

Role of the different industrial departments (Production, Quality Control, Research & Development (R&D), Quality Assurance(QA) + objectives of the regulatory authorities that check the implementation of the quality standards. Basic principles of good manufacturing practices + main differences between GMP and GLP. The focus will be set on the Good Documentation Practices (GDP), the analytical method validation and the equipment qualification.    
 

Prior Experience

Not applicable