Pharmaceutical Quality by Design MSc/PG Dip/PG Cert

Course modules

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 masters. The course is structured to ensure you have a coherent and balanced programme of study in the following areas:

• Block one: Quality by Design: Fundamental principles (30 credits)  - explores a variety of legislation and regulations relating to the quality of pharmaceutical products.
• Block two: Prod Design: Formulation Development (30 credits)  - introduces a variety of techniques and methods to formulate and produce safe medicines.
• Block three: Process Design: Manufacturing & Process Analytical Technologies (30 credits)  - design and control of manufacturing process based on the understanding of material properties and critical process parameters. The role of process analytical technologies in process identification, simulation and control.
• Block four: Biopharmaceuticals (30 credits)  - covers the use of large molecules, including those derived from biotechnology and especially those that are biologically active to produce therapeutic responses.
• Block five and six: 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.

Teaching and assessment

The learning environment for the first two semesters is varied with lectures, tutorials, seminars, laboratory-based practical’s and computer laboratories. In the third semester the learning venue will depend on your dissertation topic and will be much more aimed at guided self-study.

The course uses a variety of assessment methods relevant to a master’s level of study. The assessments include oral presentations, group work assignments, case study reports, essay writing, a research proposal and a final dissertation. 

Teaching contact hours

Contact hours in a typical week will depend to some extent on the optional modules you choose to study. However, typically you will have an average of 15 contact hours of teaching and this will break down as:

Personal tutorial/small group teaching: 1 hour of tutorials (or later, project supervision) each week

Medium group teaching: 4 hours of practical classes, workshops or seminars each week

Large group teaching: 10 hours of lectures each week

Personal study: 10 hours studying and revising in your own time each week, including some guided study using hand-outs and online activities.

Academic expertise

We have received major funds for development of our laboratories and equipment. This has allowed the purchase of equipment that matches those in the best industrial laboratories including:

• Twin-screw extrusion for continuous process manufacture
• Powder flow analysis
• Nanoparticle characterisation
• Terahertz imaging and spectroscopy
• NIR and Raman spectroscopy
• Dynamic dissolution USP IV and imaging dissolution tests
• Electro-hydrodynamic spraying of micro-particles
• Thermal analysis;
• Rheology
• Atomic force microscopy and SEM.

The core staff have been teaching for many years and have academic and industrial experiences in areas that underpin the QbD principles. These are product formulation, material science, advanced analytical sciences, and process engineering and control.

The group has evidenced its capability in this regard through recent success with the Technology Strategy Board (TSB), and Engineering and Physical Science Research Council (EPSRC) and the Biotechnology and Biological Sciences Research Council (BBSRC) grant-funded collaborative research and development, aimed to improve industrial process quality and efficiency.

Pharmacy has been taught in the faculty for over 100 years and we have gained a reputation for producing high quality graduates. Teaching expertise is of the highest calibre and many academics have experience working in the sector.