Aims and Fit of Module
GxP, which refers to “good working practices”, encompasses different standards and regulations created and enforced by national and international regulatory agencies, like the United States’ Food and Drug Administration (FDA), China’s State Food and Drug Administration ( SFDA), the European Medicines Agency (EMA) in Europe, the global International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), or World Health Organization (WHO) etc. to ensure that products, research, and projects are done safely and that the end products are safe to use. G stands for “Good”, P stands for “Practice” and x is a variable depending on the application. It can be M for “Manufacturing”, C for “Clinical”, L for “Laboratory”, S for “Storage”, D for “Distribution”, R for “Review”, etc. This module aims to provide students with the advanced knowledge of GxP and their applications in the research and development, manufacturing, control, storage, and distribution of pharmaceutical products.
A Demonstrate advanced knowledge and a critical understanding of the core principles of GxP and their applications in the research and development, manufacturing, control, storage, and distribution of pharmaceutical products.
B Demonstrate a critical understanding of the key areas covered by GxP regulations and core components of GxP readiness.
C Demonstrate a critical understanding of the GxP regulations that are applicable to different work environments and their differences, such as GMP for “Manufacturing”, GCP for “Clinical”, GLP for “Laboratory”, GSP for “Storage”, GDP for “Distribution”, GRP for “Review” or “Regulatory”, GVP (or GPvP) for “Pharmacovigilance”, GAP for “Aseptic” as well as “Computerized System Validation (CSV) for GxP etc.
D Critically appreciate the similarity and difference of GxP regulations on pharmaceutical research and development as well as pharmaceutical industry from country to country.
E Demonstrate critical understanding of GxP audits in different work environments.
Method of teaching and learning
The lectures and tutorials will be co-delivered by academic staff and industrial experts from different areas, such as manufacturing, laboratories, storage, regulatory, and clinical, etc. Field trips to selected pharmaceutical industry/GCP centre(s) will be arranged. Students will have opportunity to work in groups through tutorials, problem-based learning sessions and field trips. Timely, relevant and specific, constructive and actionable feedback will be provided to students in-class, on-paper and/or in-person on for each assignment.