Quality Assurance and Quality Control 1 (SPE200)

10 credits

Aim of this module

This rotation will enable trainees to gain skills and experience of regulation and quality assurance, and apply underpinning knowledge through introduction to the practice of regulation and quality assurance in a pharmacy. Trainees will gain experience to be able to observe, assist with, or perform a range of routine procedures in the context of providing high-quality, safe patient care and will be expected to develop and build their professional practice.

  1. Perform a pharmaceutical development and formulation exercise to meet the clinical needs of a particular patient product. 
  2. Use and critically review a quality management system. 
  3. Perform pharmacovigilance risk assessments. 
  4. Assist in and evaluate internal and external auditing of suppliers and/or contract manufacturers. 
  5. Use a change control system to document a change to a product, facility, or controlled documentation. 
  6. Identify and speciate microorganisms using a variety of techniques. 
  7. Interpret preservative efficacy test results. 
Number Work-based learning outcome Title Knowledge
1 1

Meet with the user and prepare a technical agreement that meets the needs of the user.

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2 1

Write a product specification that addresses user requirements.

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3 1

Assemble a prototype product.

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4 1

Perform product compatibility and stability testing against the specification.

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5 1

Review the results and compare against specification.

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6 2

Review a quality management system (QMS) to ensure compliance with Good Manufacturing Practice (GMP) or equivalent.

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7 2

Write a report identifying areas of good practice and recommending changes, if appropriate, to resolve issues identified.

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8 2

Present the findings of your quality management system review to members of the department.

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9 3

Identify a potential risk and perform a pharmacovigilance risk assessment.

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10 3

Write up the findings of the risk assessment as a formal report and present the findings to an internal meeting, including an action plan.

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11 4

Plan and prepare for an internal or external audit of suppliers and/or contract manufacturers.

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12 4

Assist in performing an internal or external audit of suppliers and/or contract manufacturers.

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13 4

Write up the findings of the audit as a report and present the findings to an internal meeting, including an action plan and if possible ensure closure of the audit cycle.

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14 5

Identify shortcomings in existing procedure and recommend change following assisting and writing up of an audit. 

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15 5

Assess the impact of the change in your recommendation following assisting and writing up of an audit. 

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16 5

Gain approval to implement (or not) your changes following assisting and writing up of an audit. 

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17 5

Re-evaluate the process previously audited.

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18 6

Identify and speciate microorganisms using a variety of techniques.

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19 7

Interpret preservative efficacy test results.

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You must complete
1 Case-based discussion(s)
1 of the following DOPS / OCEs
Assessment Title Type
Observe maintenance and testing of filtered air systems DOPS
Monitor temperature and conditions of storage areas of medicines and report on any out of limits results DOPS
Determine allocation of appropriate storage conditions and shelf lives DOPS
Introduce a new changing procedure DOPS
Identify a procedure in need of updating and change it DOPS
Prepare and run a multidisciplinary team meeting OCE

Important information

The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.

Learning Outcomes

  1. Discuss the role of the Clinical Scientist in Clinical Pharmaceutical Sciences in ensuring the safety of the patient, particularly related to the manufacture and quality control with reference to key patient care pathways.
  2. Discuss and critically evaluate the application of regulatory controls to pharmaceutical technology and quality assurance. 
  3. Discuss and critically evaluate the principles of quality assurance (QA) and EU Good Manufacturing Practice (GMP) and quality management systems.
  4. Design and construct manufacturing quality assurance and quality control documentation.
  5. Discuss in detail the health and safety aspects of pharmaceutical technology and quality assurance. 
  6. Describe and critically evaluate the classification of controlled areas, the monitoring of controlled areas for viable and non-viable particles, the limits to be applied to viable and non-viable particles, and the cleaning of controlled areas.
  7. Describe and critically evaluate the gowning required for working in controlled areas and be able to demonstrate putting the gowning on in a controlled and appropriate manner. 
  8. Describe and critically evaluate the operation, monitoring, cleaning and sterilisation of clean room equipment, e.g. isolators, biological safety cabinet (BSC) and laminar flow hoods. 
  9. Describe and critically evaluate the process to be followed when recalling a product from the market.
  10. Describe and critically evaluate the three routes to obtaining a manufacturing authorisation, including the associated timelines. 
  11. 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. 

Indicative Content

Clinical Pharmaceutical Science in key patient and care pathways

  • Diagnosis using radioactive materials
  • Treatment relevant to the patient and care pathway, including chemotherapy
  • Treatment using radioactive materials
  • The role of regulation, Good Manufacturing Practice, aseptic techniques and quality assurance in ensuring patient safety

Regulatory aspects

  • Consolidated Human Medicines Regulations 2012
  • The Medicines Act 1968 and its implication to medicines preparation activities, with particular attention on hospital-based work
  • The rules governing medicinal products in the European Community
  • Environmental Protection Act
  • Consumer Protection Act
  • European Commission Directives
  • Statutory Instruments
  • Medicines Act leaflets
  • Clinical Trials directive and UK implementation
  • Specifications and standards (e.g. British Pharmacopoeia)
  • Official reports (e.g. Farwell, Clothier, Rosenheim) of relevance and importance

Quality assurance

  • 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 (e.g. ISO9000)
  • Laboratory of Government Chemist (LGC) and Pharmassure schemes of intra-laboratory quality assurance
  • Governance and controls assurance, risk management and critical point control analysis
  • United Kingdom Accreditation Service
  • EU Good Manufacturing Practice (GMP) and equivalent guidelines and standards
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  • Quality assurance and technical information
  • Defective products, complaints and recall procedure
  • Inter-relationships between disciplines involved in quality assurance
  • Royal Pharmaceutical Society Hospital standards

Documentation and records

  • Quality assurance/control documentation
    • Sampling programmes
    • Standard operating procedures (SOPs).
    • Specifications/worksheets
    • Testing methods
    • General laboratory records
    • Status labelling systems,
    • Information management systems
    • Change control
  • Production documentation
    • Master formula and manufacturing method
    • Batch manufacturing records
    • Batch packaging records
    • SOPs, log books,
    • Special records, e.g. sterilisation, clinical trials, exception/deviation reports,
    • Cross-contamination monitoring
    • Cleaning schedules
    • Materials management documents,
    • Exception/Variation reporting, including product quality review

Document design

  • Authorisation, control and indexing the documentation
  • Updating and version control
  • Archiving and alternatives to paper documents
  • (Microfilm, Electronic Data Processing),

Manufacturing authorisation application

  • Relationship of documentation to manufacturing authorisation data and any subsequent
  • The cost/benefit of taking products to market authorisation
  • Construction of application form and data required