MSc Pharmaceutical Technology and Quality Assurance

Year of entry: 2022

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Course unit details:
Introduction to Clinical Pharmaceutical Science 2B

Unit code PHAR61800
Credit rating 30
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

 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 Microbiology
  • Micro-organisms, Microbial growth (form and actions of microbes)
  • Sources of microbiological contamination
  • Potential risks from microbial contamination. (Pathogens and infection risks)
  • Spoilage and control / preservation
  • Maintenance of essential documentation
  • Completion of all logs, worksheets and reports
  • Completion of necessary training records

Formulation Sciences (10 credits)

  • Pharmaceutical Formulation and Processing
  • Sources, preparation and purification of major drug substances and excipients
  • Formulation
  • Stability studies
  • Drug administration systems
  • Analytical method development
  • Specification development
  • Presentation of the product in relation to its method of use and/or administration
  • Equipment calibration
  • Rational approach to process validation
  • Principles of formulation
  • Solutions, topical liquids
  • Semisolids, creams and ointments,
  • Injections including parenteral infusions e.g. nutrition mixtures
  • Tablets, capsules, cachets
  • Specialised dose forms for medicinal purposes (powders, depot products, inhalation products, transdermal products)
  • Extemporaneous preparation
  • Properties of excipients and ingredients in pharmaceutical produ

Aims

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

1.  Module 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.

2.  E-Learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

 

Knowledge and understanding

Students should be able to:

Radiopharmacy (10 credits) 

  1. Discuss the UK regulatory requirements which apply to the design and operation of radiopharmacies and the different possible solutions to these requirements.
  2. Recognise the different types of radiopharmaceuticals in routine clinical practice together with any particular problems arising from their use
  3. Describe the types of activities normally undertaken in a hospital radiopharmacy.
  4. Describe the ways in which radiopharmaceuticals are prepared.
  5. 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.
  6. Describe how the principles of Quality Assurance are routinely applied in a radiopharmaceutical production system.
  7. Explain the nomenclature, principles, and mechanisms of atomic reactions
    1. 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.
    2. 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).
    3. Critically appraise the impact of the pharmaceutical production process on the quality of the clinical outcomes.

Practical skills

  1. Demonstrate professionalism and ethical awareness.
  2. Apply the principles of EU Good Manufacturing Practice (GMP) to develop a safe new product.
  3. Perform all manufacturing activities in accordance with requirements for Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems.

Transferable skills and personal qualities

  1. Communicate effectively in a variety of settings with a range of individuals.
  2. Use logical and systematic approaches to problem-solving and decision-making.
  3. Use effective negotiation skills, including influencing colleagues.

Assessment methods

Method Weight
Written exam 100%

Aseptics Portfolio

(Critically reviewed observations/evidence documented against all topics required by portfolio specification.)

 Pass/Fail

Radiopharmacy Portfolio Presentation - 15 minutes

(Critically reviewed observations/evidence documented against all topics required by portfolio specification.)

Pass/Fail

Feedback methods

Feedback on assignments is provided 3 weeks after submission.

Feedback on examination performance is provided following the relevant Board of Examiner's meeting.

Recommended reading

Radiopharmacy

  1. Zolle, I (Ed)  2007 Technetium-99m Pharmaceuticals: Preparation and Quality Control in Nuclear Medicine.  Berlin: Springer  ISBN-10: 3-540-33989-2  ISBN-13: 978-3-540-33989-2
  2. Theobald, T. 2010 Sampson’s Textbook of Radiopharmacy 4th Edition.  London: Pharmaceutical Press  ISBN-10: 0853697892  ISBN-13: 978-0853697893
  3. ARSAC: Notes for guidance

Online at http://www.arsac.org.uk/notes_for_guidance/

  1. Saha, G.B. 1998 Fundamentals of Nuclear Pharmacy 5th Edition.  New York: Springer Science and Business Media  ISBN-10: 0387983414  ISBN-13: 978-0387983417
  2. Welch, M.J and Redvanly, C. S. (Ed) 2002 Handbook of Radiopharmaceuticals: Radiochemistry and applications.  Chippenham: John Wiley & Sons Ltd  ISBN-10: 0471495603  ISBN-13: 978-0471495604
  3. Kowalsky, R and Falen, S.W. 2011 Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine 3rd Edition.  Washington: American Pharmacists Association  ISBN-10: 1582121184  ISBN-13: 978-1582121185
  4. Quality Assurance of Radiopharmaceuticals

Online at http://www.bnms.org.uk/images/stories/UKRG/UKRG_QA_Apr-12.pdf

  1. Guidelines for the safe preparation of radiolabelled blood cells

Online at http://www.bnms.org.uk/images/stories/downloads/documents/ukrg_blood_labelling_2009.pdf

  1. Responsibilities of Chief Pharmacists for the purchase and supply of radiopharmaceuticals

Online at http://www.bnms.org.uk/images/stories/downloads/documents/ukrg_purchase_responsibilities_2009.pdf

Aseptics

  1. Farwell, J. 1994 Aspetic dispensing for NHS patients: a guidance document for pharmacists in the United Kingdom.  London: Department of Health
  2. Lund W. (Ed) 1994 The Pharmaceutical Codex 12th Edition. London: Pharmaceutical Press ISBN-10: 0853692904  ISBN-13: 978-0853692904
  • Validation                                                        p.389-397
  • Pharmaceutical microbiology                         p.483 – 508
  • Aseptic Processing                                        p.561 – 568
  • Cleanrooms for pharmaceutical production   p.569 - 576
  1. Beaney, A. (Ed) 2006 Quality Assurance of Aseptic Preparation Services: 4th Edition.  London: Pharmaceutical Press  ISBN 0-85369-615-2
  2. Guidelines for good manufacturing practices for medicinal products for human and

Study hours

Scheduled activity hours
Assessment written exam 2.5
Practical classes & workshops 66
Independent study hours
Independent study 231.5

Teaching staff

Staff member Role
Simon Bath Unit coordinator
Beverley Ellis Unit coordinator
Ruth Ledder Unit coordinator
John Landers Unit coordinator

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