MSc Pharmaceutical Technology and Quality Assurance
Year of entry: 2024
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Course unit details:
Introduction to Pharmaceutical Science 2
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Variable teaching patterns|
|Available as a free choice unit?||No|
Radiopharmacy (10 credits)
- UK regulatory requirements which apply to the design and operation of radiopharmacies and the different possible solutions to these requirements
- Radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use
- Activities normally undertaken in a hospital radiopharmacy
- Radiopharmaceuticals preparation
- Quality Assurance in Radiopharmacy in particular and describe the most important means of control of aseptic preparation and how the principles of QA are routinely applied in a radiopharmaceutical production system
- Nomenclature, principles, and mechanisms of atomic reactions
- The design and principles of particle accelerators and nuclear reactors and their relevance for production of radionuclides used in Nuclear Medicine
- Qualitative and quantitative terms the interactions of radiation with biological systems, discuss the relative risks of nuclear medicine procedures compared to other potentially hazardous life events
- The principles of the most important types of radiation detectors used in Nuclear Medicine together with the way in which they are normally employed
- The structure of the atom, the most important means of radioactive decay of unstable nuclei and the types of radiation emitted therefrom
- Radionuclides used in nuclear medicine
- The relationships between their physical properties, their clinical applications, and their strengths and weaknesses
- The radiopharmaceutical chemistry of these radionuclides
- The influence of these chemical properties on the biodistribution of their radiopharmaceuticals
- The different formulations used in nuclear medicine; properties and preparation
- Radiopharmaceutical kits and reagents used therein
Aseptics (10 credits)
- Facilities and equipment
- Principles of aseptic manipulation
- Practical application of quality assurance
- Aseptic technique
- Compliance with regulatory and operational requirements
- Effective working within aseptic processing environments
- Pharmaceutical Mic
- The unit aims to provide students with background knowledge of radiopharmacy, aseptic preparation and product formulation. The unit provides a good proportion of practical study, enabling students to appreciate how the theory applies in practice.
- The radiopharmacy element allows students to appreciate the unique needs of the department in ensuring radiation protection.
- The aseptic element provides students with an in-depth working knowledge of pharmaceutical microbiological aspects of aseptic manufacture and preparation. Students will also develop an ability to evaluate the use of cleanrooms and clean air devices in order to maintain patient safety.
- The formulation sciences element will define the principles of pharmaceutical science and formulation. Students will understand the process of designing a new product and building the analytical specifications and stability studies in order to bring a new product to market.
Teaching and learning methods
- Unit-specific teaching blocks, including workshops and practicals. The teaching component for radiopharmacy is provided by King’s College Hospital, London and is delivered by clinical experts in their field; including radiopharmacists, physicists and senior medical staff.
- E-learning: evidence-based learning supported by course notes, audio lectures and discussion boards.
Knowledge and understanding
Radiopharmacy (10 credits)
- Discuss the UK regulatory requirements which apply to the design and operation of radiopharmacies and the different possible solutions to these requirements.
- Recognise the different types of radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use.
- Describe the types of activities normally undertaken in a hospital radiopharmacy.
- Describe the ways in which radiopharmaceuticals are prepared.
- Discuss the general principles of QA in everyday life and in hospital pharmacy in particular including the most important means of control of aseptic preparation.
- Describe how the principles of Quality Assurance are routinely applied in a radiopharmaceutical production system.
- Explain the nomenclature, principles, and mechanisms of atomic reactions
- Describe the design and principles of particle accelerators and nuclear reactors and their relevance for production of radionuclides used in Nuclear Medicine.
- Describe in both qualitative and quantitative terms the interactions of radiation with biological systems and discuss the relative risks of nuclear medicine procedures compared to other potentially hazardous life events.
- Describe the principles of the most important types of radiation detectors used in Nuclear Medicine together with the way in which they are normally employed.
- Describe the structure of the atom, the most important means of radioactive decay of unstable nuclei and the types of radiation emitted.
- Recognise the radionuclides used in nuclear medicine and discuss the relationships between their physical properties, their clinical applications, and their strengths and weaknesses.
- Describe the radiopharmaceutical chemistry of these radionuclides and discuss the influence of these chemical properties on the biodistribution of their radiopharmaceuticals.
- List the different formulations used in nuclear medicine; describe their properties and the way in which these formulations are prepared; discuss the significance of the development of radiopharmaceutical kits and describe the function of the various reagents used therein.
Aseptics (10 credits)
- Understand the principles of design of facilities.
- Explain the principles of aseptic manipulation.
- Describe the principles of basic pharmaceutical microbiology.
- Analyse and interpret monitoring data and diagnose problems.
- Evaluate monitoring equipment and operational records.
- Explain the key chemical and physical reactions affecting the stability of medicinal products.
- Resolve drug formulation and administration problems, particularly where they relate to the modification and optimisation.
Formulation Sciences (10 credits)
- Describe the principles of pharmaceutical formulation and processing.
- Describe the properties of excipients and ingredients.
- Appraise and interpret information from different sources in order to develop a coherent critical analysis of issues relating to the practice and delivery of clinical pharmaceutical science services.
- Perform detailed investigations in order to establish the root cause of exceptions using a variety of tools available. To perform detailed risk assessments and to allocate appropriate corrective and preventive actions (CAPA).
- Critically appraise the impact of the pharmaceutical production process on the quality of the clinical outcomes.
- Demonstrate professionalism and ethical awareness.
- Apply the principles of EU Good Manufacturing Practice (GMP) to develop a safe new product.
- Perform all manufacturing activities in accordance with requirements for Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems.
Transferable skills and personal qualities
- Communicate effectively in a variety of settings with a range of individuals.
- Use logical and systematic approaches to problem-solving and decision-making.
- Use effective negotiation skills, including influencing colleagues.
Provisional marks and feedback for coursework returned within 15 working days.
Exam marks and final marks returned after ratification at exam board.
|Scheduled activity hours|
|Independent study hours|
|Simon Bath||Unit coordinator|
|Victoria Gibson||Unit coordinator|
|Beverley Ellis||Unit coordinator|
|Ruth Ledder||Unit coordinator|
|John Landers||Unit coordinator|
|James Walker||Unit coordinator|