Objectives of general skills

• 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.
• 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

UE's Learning outcomes

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

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

Sans objet

Term 1 for Integrated Assessment - type

• Oral examination
• Written examination

Term 2 for Integrated Assessment - type

• N/A

Term 3 for Integrated Assessment - type

• N/A

Resit Assessment for IT - Term 1 (B1BA1) - type

• Oral examination
• Written examination