MSc Pharmaceutical Technology and Quality Assurance

Year of entry: 2022

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Course unit details:
Introduction to Clinical Pharmaceutical Science 2A

Unit code PHAR61790
Credit rating 30
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Full year
Offered by Pharmacy
Available as a free choice unit? No

Overview

 Production (10 credits)

·         Quality Assurance

§  Quality Assurance

§  Quality Audits

·         Product Design

§  Developing a product specification

§  Packaging requirements

§  Labelling requirements and regulations

§  Stability considerations

·         Manufacture, Assembly, Preparation and Dispensing

§  Solid dose forms

§  Liquid oral medicines

§  External liquids

§  Semi-solids (ointments, creams, gels and pastes)

§  Sterile topical liquids

§  Irrigations

§  Injections and infusions

§  Miscellaneous others

·         Processes

§  Weighing

§  Measuring

§  Milling

§  Mixing

§  Filling

§  Sealing

§  Filtration - clarification/sterilisation

·         Sterilisation Methods

§  Application of Microbiology to Sterilisation Techniques

§  HTM 2010 - Sterilisers

§  Sterilisation by moist heat

§  Sterilisation by dry heat

§  Gaseous sterilisation

§  Sterilisation by irradiation

·         Pharmaceutical Water

§  Water purification and storage

§  Pharmaceutical handling and quality

§  HTM 2031 – Clean Steam

§  HTM 2030 – Washers

 

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 fr

Aims

The unit aims to provide students with background knowledge of formulation sciences, aseptic preparation and classical batch manufacture. The unit provides a good proportion of practical study enabling students to appreciate how the theory applies in practice. 

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. 

Production will prepare students to evaluate and develop services in production of pharmaceuticals. Content includes principles and management of pharmaceutical production, requirements of QA in application to theory and practice of manufacturing and sterilisation of products.

Teaching and learning methods

  • Unit-specific teaching blocks including workshops and practicals.
  • E-learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

 

Knowledge and understanding

Production (10 credits) 

  • Discuss the role of the technical services professional in ensuring the safety of the patient, particularly related to the manufacture of licensed and unlicensed products and Investigational Medicinal Products including cytotoxic drugs for the treatment of cancer.
  • Apply management principles to the detailed structure of the production process.
  • Describe the principles of Quality Assurance in relation to pharmaceutical production.
  • Show the relevance of pharmaceutical law and regulations.
  • Explain the process of product design.
  • Explain and critically evaluate the theory and practice of pharmaceutical manufacturing, assembly, preparation and dispensing.
  • Apply the principles of processing in regard to pharmaceutical production.
  • Explain the principles of sterilisation by irradiation, filtration, gas, moist and dry heat.

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 in pharmaceutical products.
  • Explain the factors affecting formulation, stability and preservation of pharmaceutical product.
  • Perform mathematical calculations relevant to pharmaceutical formulation.
  • Describe the principles of sterilisation.
  • Understand the criticality of final packaging.

Intellectual skills

  • 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.
  • Reviewing of technical agreements with suppliers and service providers.
  • Perform analytical method validation and equipment validation.
  • Interpret QC data and investigate questionable results.

Practical skills

  • 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.
  • Work within the principles and practice of instruments, equipment and methodology used in pharmacy technical services.
  • Support safe storage and distribution of medicinal products.
  • Identify validation requirements for any changes to processes.

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.
  • The ability to plan and devise a framework and timetable for action and carry these out systematically, either for individual purposes or in a group context.

Assessment methods

Method Weight
Written exam 100%

 

Aseptics Portfolio

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

 Pass/Fail

Production Portfolio Presentation - 15 minutes

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

 Pass/Fail

Feedback methods

Provisional marks and feedback for coursework returned within 15 working days.

Exam marks and final marks returned after ratification at exam board. 

Study hours

Scheduled activity hours
Assessment written exam 2
Lectures 66
Independent study hours
Independent study 232

Teaching staff

Staff member Role
Ruth Barnes Unit coordinator

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