Aims and Fit of Module
GxP are the quality standards and regulations for a specific field or activity (x). The aim of this module is to equip students with the general philosophy of GxP and skills to apply the relevant tools and techniques of GxP to pharmaceutical industry, and to provide students with comprehensive knowledge on GxP requirements/regulations and audits in quality management.
A Demonstrate a critical understanding of well-established pharmaceutical or pharmaceutical industry GxP requirements and/or regulations.
B Demonstrate ability to apply the relevant GxP regulation that is applicable to their own work environment, to well defined contexts, such as GMP for manufacturing practices and GLP for laboratory work.
C Demonstrate ability to apply the relevant tools and established techniques used in GxP risk-based compliance to a work-related activity, producing a summary report and recommendations.
D Demonstrate knowledge and critical understanding of audits in quality management and carry out an internal compliance audit in accordance with the legislative requirements.
Method of teaching and learning
Experts from the industry will be invited to co-delivering the module in the form of lectures, tutorials, and field trips to selected pharmaceutical industry/GCP centre(s) will be arranged. Students will have the 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 for each assignment.
Students will attend a 2-hour lecture and a 1-hour tutorial per week. A 20-hour industry site visit was designed to give students an on-site understanding of this module. Students will also be given guidance and opportunities to practice the various skills mentioned in the specifications. Self-study activities will be extensions or consolidations of work carried out in the lecture and tutorial. Assessment components of this module will include: 1) questions or tests in lectures or tutorials; 2) coursework to review the topics; 3) group discussion or report that summarizes the on-site visit or the lecture topics; and 4) presentation of a critique of the teaching topics. The feedback will help improve the teaching quality and ensure the quality of summative assessment.