MSc Pharmaceutical Technology and Quality Assurance
Year of entry: 2022
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Course unit details:
Foundations of Pharmaceutical Technology and Quality Assurance
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Semester 1|
|Available as a free choice unit?||No|
· The Medicines Act and its implication to “specials” manufacturing and preparation activities, with particular attention on hospital-based work.
· Consolidated Human Medicines Regulations
· The rules governing medicinal products in the European Community
· Environmental Protection Act
· Consumer Protection Act
· EEC Directives
· Statutory Instruments
· Medicines Act leaflets
· Clinical Trials directive and UK implementation
· Specifications and standards (British Pharmacopoeia, Ph, Eur, etc.)
· Official reports (Farwell, Clothier, Rosenheim etc.) of relevance/importance
· Quality Assurance, including management and organisational aspects
· Quality Risk Management
· Quality Management Systems
· Quality Audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of Clinical Governances, Controls Assurance standards, Risk Management/Assessment and Critical Point Analysis
· The role of the Qualified Person
· Quality System Review.
· Quality Management Standards BS.5750 – ISO 9000 etc.
· LGC Schemes and Pharmassure Laboratory of Government Chemist (LG)
· Governance and Controls Assurance, Risk Management and Critical Point Control Analysis.
· Good Manufacturing Practice (GMP)
· International Good Manufacturing Practice (GMP) guidelines and standards. (ICH)
· Quality Assurance and technical information database.
· Defective products, complaints and recall procedure
· Inter-relationships between disciplines involved in quality assurance
· Royal Pharmaceutical Society Hospital standards
Documentation and Records
Ø Quality Assurance / Control Documentation
· Sampling programmes
· Standard Operating Procedures (SOPs).
· Specifications / worksheets
· Testing met
The unit provides the background knowledge required by the students undertaking the Pharmaceutical Technology and Quality Assurance (PTQA) programme. Students following different career paths will all require the core knowledge provided by this unit in order to progress through their own choices and to gain an appreciation of alternative routes through the programme.
The unit provides the students with an essential grounding in pharmaceutical quality assurance which underpins all GMP activities. Students will engage with lecturers and reading material to gain a full understanding of the regulatory framework governing pharmaceutical preparation and manufacture within the NHS.
It will also provide a fundamental understanding of Pharmaceutical Quality Systems (PQS) and the operational benefits and challenges of a robust system. The key documents of a PQS will be defined.
Teaching and learning methods
- A teaching block including workshops and practicals.
- E-learning: evidence-based learning supported by course notes, audio lectures and discussion boards.
Knowledge and understanding
- Discuss and critically evaluate the application of regulatory controls to pharmaceutical technology and Quality Assurance.
- Discuss and critically evaluate the principles of Quality Assurance (QA) and EU Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems (PQS).
- Implement the fundamentals of good document design throughout the whole PQS.
- Design and construct manufacturing, Quality Assurance and Quality Control documentation.
- Discuss in detail the health and safety aspects of Pharmaceutical Technology and Quality Assurance.
- Describe and critically evaluate the process to be following when recalling a product from the market.
- Describe and critically evaluate the three routes to obtaining a Manufacturing Authorisation including the associated timelines.
- Describe the contents of an electronic Common Technical Document (eCTD) for a licensed product, with the Chemistry Manufacturing and Controls (CMC) section being described in detail.
- Follow regulatory standards and guidance.
- Evaluate scientific and clinical literature and present appropriately.
- Critically appraise concepts and measures of quality and quality assurance and their links with the effective and efficient management of resources and improvement of service delivery.
- Prepare technical documents; product specifications, investigation reports.
- Prepare risk assessments using a variety of tools and techniques.
- Interpret complex data and report on the findings.
- Prepare for an internal or external audit.
- Identify shortcoming in existing procedure and recommend change.
- Assess the impact of change.
Transferable skills and personal qualities
- Read, interpret and apply standards and guidance to working practices.
- Demonstrate professionalism and ethical awareness.
- Communicate effectively with professional colleagues and service users.
- Select and apply appropriate analysis or assessment techniques and tools.
|Written assignment (inc essay)||30%|
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|
|Assessment written exam||1.5|
|Independent study hours|
|Ruth Barnes||Unit coordinator|