The objective of this course is to give a clear and accurate 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 that unite these two quality standards and their specificity (e.g. their application scope).
The main pedagogical goal of this course is to present an overview the "Good Practices" as tools that can then be translated and applied into academic research. The idea is to implement the appropriate level of “Quality” to improve the traceability, integrity and the reliability of the research work (as per recommended by WHO in their guideline “Quality Practices in Basic Biomedical Research”. It also aims to demystify and better prepare for industrial reality.
The role of the different industrial parts (Production, Quality Control, Research and Development, Quality Assurance, Regulatory Affairs, …) will be reviewed and discussed. We will then see in more detail the different basic principles of Good Manufacturing Practices as well as the main differences between GMP and GLP. The focus will be on Good Documentation Practices (BPD), the validation of analytical methods.
Teaching / Method:
Copy of the slide decks
- Titulaire: Gaël DEBAUVE