Course Content
Course modules
The Pharmaceutical Quality by Design course will provides an understanding of the challenges faced by the pharmaceutical and healthcare industries as they strive to develop new products and equips you with modern product development and manufacturing solutions that conform to current industry best practices and modern QbD principles.
The course contains areas of core knowledge and skills with an emphasis on application of QbD principles and continuous improvement activities to the development and manufacture of pharmaceutical products. 180 credits must be completed to achieve a full master’s. The course is structured to ensure you have a coherent and balanced programme of study in the following areas:
- Quality by Design - QbD (15 credits) - explores a variety of legislation and regulations relating to the quality of pharmaceutical products.
- Product Design: Pre-formulation and Formulation (30 credits) - introduces a variety of techniques and methods to formulate and produce safe medicines.
- Analytical Techniques in Materials Science (15 credits) - builds on the concept of materials science as a separate discipline.
- Process Design and Manufacturing (15 credits) - considers the design, including facility, equipment, material transfer, and manufacturing variables using QbD principles.
- Advances in Drug Delivery (15 credits elective) - focuses on new therapeutic entities and delivery strategies. It is intended to integrate with ideas in other subject areas presented in the course, but also for the appreciation of future developments.
- Biopharmaceuticals (15 credits elective) - covers the use of large molecules, including those derived from biotechnology and especially those that are biologically active to produce therapeutic responses.
- Process Analytical Technology and Chemometrics (15 credits) - describes online process monitoring and the use of Process Analytical Technology (PAT) to advance pharmaceutical process identification, simulation and control.
- Experimental Design and Research Methods (15 credits) - focuses on research and experiment design methods applying QbD principles. The importance of design space concept will be discussed. Issues are primarily illustrated through examples from industrial cases.
- Dissertation (60 credits) - aims to provide each student with an opportunity to consolidate their knowledge of quality by design applied to pharmaceutical science by carrying out a research or development project in an area directly related to pharmaceutical manufacturing
