Taught course

Pharmaceutical Quality by Design

Institution
De Montfort University · Faculty of Health and Life Sciences
Qualifications
MSc

Entry requirements

  • A good honours degree (minimum 2:2 or equivalent) in a chemical, biological or physical science, including (though not exclusive to) chemistry, biology, chemical engineering, engineering, pharmacy, pharmaceutical science, or physics (or equivalent)
  • Alternatively, we will accept a portfolio of professional and/or academic qualifications of equivalent standing to an honours degree.

English language requirements:

If English is not your first language an IELTS score of 7 or equivalent when you start the course is essential. English language tuition, delivered by our British Council accredited Centre for English Language Learning (CELL), is available both before and during the course.

Please visit dmu.ac.uk/international for more information.

Months of entry

September

Course content

Reasons to study Pharmaceutical Quality by Design at DMU:

  • 100 per cent of graduates seeking to enter employment or further study are successful within six months of graduating (DLHE 2013/14)
  • Our experienced practitioner and research-based academic staff have recently received grant-funded collaborative research and development to improve industrial process quality and efficiency, with Innovate UK (formerly TSB), the Engineering and Physical Science Research Council (EPSRC) and the Biotechnology and Biological Sciences Research Council (BBSRC)
  • Benefit from our extensive funding and investment in our industry standard laboratories and specialist equipment including USP IV dissolution and surface imaging dissolution, pilot scale twin-screw extrusion for continuous manufacture, electron microscope, thermal and mechanical analysers, freeze drying and tablet manufacturing facilities
  • Benefit from strong links, direct input and guest lectures from industrial experts ensuring your learning is relevant to current practice and developments within the sector
  • Become a graduate with current knowledge and skills required by the pharmaceutical industry. This is the first MSc dedicated to the new “Quality by Design” approach to pharmaceutical process and product development
  • The course content is aligned with the Guidelines from the International Conference on Harmonization (ICH) Q8, Q9, Q10 and Q11, an initiative being driven and supported by the US, EU and Japanese regulatory authorities
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

Fees and funding

UK students
6,550
International students
15,400

As part of the university's commitment to enhancing the personal and career development of our graduates. We offer an Alumni scholarship programme. For more information visit Health and Life Sciences Alumni Scholarships.

Name
Gunn and Carter Fellowship £3000 per annum.

Description

To support research in the Leicester School of Pharmacy.

Qualification and course duration

MSc

full time
12 months

Further details of qualification

This course equips graduates with the relevant knowledge and skills to compete for jobs in pharmaceutical and healthcare sectors linked to industry or academia all over the world. There are career opportunities in areas such as product development, manufacturing, regulatory affairs, marketing and clinical research, and jobs include:

Course contact details

Name
Health and Life Science Admissions Division
Email
hls@dmu.ac.uk
Phone
+44 (0)116 257 7700