Quality Assurance and Quality Control 2 (SPE222)

10 credits

Aim of this module

This module will enable the trainee to consolidate their experience of the systems and processes that contribute to the provision of high-quality, safe clinical pharmaceutical services and apply their knowledge in a clinical setting. This module provides the trainee with the knowledge that underpins the specialist module in the practice of Clinical Pharmaceutical Science and provides the  trainee with the knowledge and understanding that underpins and is applied to work based learning.

  1. Lead an internal or participate in an external audit to ensure that processes are in compliance with requirements to provide a safe product in the setting of a quality system.
  2. Identify specific quality control functions that feed in to the quality management system to provide assurance that all activities within the unit are adequately controlled to provide valid and reliable results to allow for safe release of product(s).
  3. Perform a range of chemical analytical techniques that provide evidence of product quality to ensure that samples/products meet the agreed specifications analysing, interpreting, reporting and acting on the results.
  4. Perform a range of microbiological techniques to assist in providing evidence of product and facility compliance and analyse, interpret and report the test results.
  5. Obtain samples, perform a range of measurements, analyse, interpret and report data to contribute to the sampling requirements process as part of quality control testing.
Number Work-based learning outcome Title Knowledge
1 1,2,3,4,5

Perform a range of processes and procedures in accordance with laboratory health and safety guidelines to ensure that safe working practices and a safe environment are maintained.

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2 1

Use personal protective equipment (PPE), Material Safety Data Sheets (MSDS) and Control of Substances Hazardous to Health (COSHH) risk assessments.

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3 1

Write a Control of Substances Hazardous to Health risk assessment for a laboratory reagent used in your unit, ensuring it is used as part of the health and safety practice of the unit, storing the assessment appropriately.

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4 1

Identify the subject area and plan the audit, ensuring the necessary permissions are in place.

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5 1

Undertake/participate in the audit.

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6 1

Analyse and interpret the data from the audit and prepare a written report, including an action plan.

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7 1

Present the findings from a clinical audit to an audience of peers.

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8 2

Perform an out-of-specification investigation (OOS) and present findings.

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9 2

Evaluate how that OOS result could affect the safety and efficacy of the product tested.

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10 2

Identify the critical individual steps required for analytical method validation and revalidation requirements.

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11 2

Perform an analytical method validation.

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12 2

Identify the critical individual steps required for equipment validation and revalidation requirements.

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13 2

Produce a product quality review report.

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14 2

Evaluate continuing compliance and highlight any risks to patient or quality assurance.

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15 2

Interpret quality control data to enable product release, and if appropriate release product.

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16 3

Perform high-performance liquid chromatography (HPLC).

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17 3

Perform various spectroscopic techniques, interpret and report the analytical outputs.

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18 3

Perform pH measurement, interpret and report the analytical outputs.

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19 3

Perform volumetric analysis, interpret and report the analytical outputs.

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20 3

Perform identification tests analysis and interpret and report the analytical outputs.

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21 3

Perform, interpret and report on a range of other chemical techniques used to ensure that samples/products meet the agreed specifications appropriate to your unit.

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22 4

Perform a range of environmental monitoring procedures, including physical and microbiological techniques.

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23 4

Analyse the results from environmental monitoring to identify trends and determine the statistical importance/significance of results.

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24 4

Produce a written report in the required format and present your findings at a departmental meeting.

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25 4

Perform a range of microbiological techniques, including:

  • operator, tests universal broth transfer
  • finger dabs/contact plates, etc.
  • Gram stain/species tests
  • sterility testing
  • total viable count
  • endotoxins
  • broth fills.
  • simple organism identification.
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26 4

Analyse the results from microbiological testing to identify trends and determine the statistical importance/significance of results.

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27 4

Produce a written report in the required format and present your findings at a departmental meeting.

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28 5

Use appropriate sampling plans and strategies to obtain samples.

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29 5

Perform a range of measurements for quality control analysis.

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30 5

Analyse, interpret and report data from each measurement.

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31 5

Critically evaluate how different sampling strategies and methods contribute to quality control within a quality environment, producing a short report to influence future practice.

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You must complete
3 Case-based discussion(s)
2 of the following DOPS / OCEs
Assessment Title Type
Devise a protocol for stability testing a product and perform preliminary and the first analysis of this product DOPS
Identify an SOP in a GMP area that is in need of updating and use the change control procedure to implement the necessary changes DOPS
Determine allocation of appropriate storage conditions and shelf lives DOPS
Discuss how you would approach stability studies for both new manufactured products and new aseptically dispensed products OCE
Investigate and map the management of documentation systems within a GMP area. Challenge the archiving recall procedure to find production documentation relating to a historical product from 5 years ago. 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 Pharmaceutical Sciences in ensuring the safety of the patient, particularly related to the manufacture of licensed and unlicensed products and investigational medicinal products (IMPs), with reference to key patient pathways such as cancer.
  2. Explain the theory and use of all pharmaceutical microbiological and analytical techniques and instruments in a pharmaceutical quality control laboratory.
  3. Discuss the quality of medicinal products, including raw materials, licensed  and unlicensed products, ‘specials’, IMPs, medical and surgical devices, and medical gases.
  4. Discuss the responsibilities required for managing a quality assurance system.
  5. Discuss the role of quality audits and quality system reviews.
  6. Justify the choice of, and apply statistical methods to, sampling and testing.

Indicative Content

Techniques and instrumentation

  • Volumetric analysis – aqueous and non-aqueous
  • Identification tests, test tube reactions, limit tests
  • Gravimetric analysis
  • Refractometry
  • Melting point
  • Polarimetry
  • Spectroscopy – ultraviolet (UV)/visible
  • Spectroscopy – infrared (IR)
  • Spectroscopy – atomic absorption
  • Electrochemistry/pH
  • Particulate measurement, liquids
  • Solid dose    forms,    physical   testing    methods   (e.g.    hardness,   friability, disintegration; theoretical only)
  • Dissolution (theoretical only)
  • Thin-layer chromatography (TLC)
  • High-performance liquid chromatography (HPLC)
  • Gas chromatographyIon separation chromatography
  • Endotoxin and pyrogen testing (theory)
  • Pharmaceutical microbiology     –     sterility     testing,     non-sterile     product microbiology, water systems testing, preservative efficacy testing

The quality control department

  • Control of quality and the role of the quality controller
  • Unlicensed products and ‘specials’
  • Involvement in clinical trials
    • Governance
    • Ethics
    • Quality assurance
    • Monitoring

Product testing

  • Purchased medicines
  • Raw materials
  • Final products

Medical gases

  • Range and users of medical gases
  • Health Technical Memorandum 02 and permit-to-work system
  • Role of ‘quality controller’ in medical gas testing
  • On-site testing

Clean room qualification

  • Air quality determination
    • Room over-pressures
    • Viable and non-viable particle counts
    • Air flow
    • Air change rate

Statistics

  • Application of statistical methods to sampling and testing methods