Module information
Module details
- Title
- Quality Control
- Type
- Specialist
- Module code
- S-PS-S4
- Credits
- 10
- Phase
- 3
- Requirement
- Compulsory
Aim of this module
This module will provide trainees with the knowledge, understanding and practical skill in using a range of analytical techniques to analyse pharmaceutical starting materials, packaging components, in-process samples and products of various dosage form presentations.
Trainees will also gain an understanding of the place of quality control in the wider area of pharmaceutical quality assurance and ensuring patient safety.
Work-based content
Training activities
| # | Learning outcome | Training activity | Type | Action |
|---|---|---|---|---|
| # 1 | Learning outcome 4,7 |
Training activities
Write a test specification for:
|
Type DTA | Action View |
| # 2 | Learning outcome 1,2,4,7 |
Training activities
Perform testing of starting materials to a pharmacopoeial or in-house specification to include:
|
Type DTA | Action View |
| # 3 | Learning outcome 1,2,4,7 |
Training activities
Perform testing of packaging components to include two of the following:
|
Type DTA | Action View |
| # 4 | Learning outcome 1,2,4,7 |
Training activities
Perform testing of the following types of pharmaceutical products to include HPLC or GC analysis:
|
Type ETA | Action View |
| # 5 | Learning outcome 1,2,3,4,5,7 |
Training activities
Investigate a questionable laboratory result or out of trend result |
Type ETA | Action View |
| # 6 | Learning outcome 4,5,7 |
Training activities
Review a completed stability testing protocol for regulatory compliance and acceptability of risk-based approach including the allocation of shelf-life |
Type DTA | Action View |
| # 7 | Learning outcome 2,3,7 |
Training activities
Perform enumeration and identification of organisms on environmental monitoring samples |
Type ETA | Action View |
| # 8 | Learning outcome 3,5,7 |
Training activities
Undertake and report physical monitoring of cleanrooms to include:
|
Type DTA | Action View |
| # 9 | Learning outcome 6 |
Training activities
Plan testing required for a piped medical gas system |
Type DTA | Action View |
| # 10 | Learning outcome 5,7 |
Training activities
Audit the processes for handling of laboratory data and test results and make recommendations for improvements including the following:
|
Type DTA | Action View |
Assessments
Complete 2 Case-Based Discussions
Complete 2 DOPS or OCEs
Direct Observation of Practical Skills Titles
- Take a pH measurement.
- Take a conductivity measurement.
- Count colonies on a settle or contact plate.
- Perform a titration.
Observed Clinical Event Titles
- Explain a questionable result to a customer.
- Feedback an investigation outcome to an analyst.
Learning outcomes
| # | Learning outcome |
|---|---|
| 1 | Perform a range of chemical analytical techniques that provide evidence of product quality to ensure that samples meet the agreed specifications; analysing, interpreting, reporting and acting on the results. |
| 2 | Perform a range of microbiological analytical techniques that provide evidence of product quality to ensure that samples meet the agreed specifications; analysing, interpreting, reporting and acting on the results. |
| 3 | Apply physical and environmental monitoring tests to provide evidence of facility compliance and ascertain compliance with requirements. |
| 4 | Write specifications for routine quality control and stability assessment based on relevant standards and guidance. |
| 5 | Investigate questionable laboratory results or out of trend results following quality system requirements, liaising with analysts, supervisor and customers where appropriate. |
| 6 | Plan testing required for a piped medical gas system. |
| 7 | Describe the requirements of data integrity related to quality control systems. |
Clinical experiences
Clinical experiences help you to develop insight into your practice and a greater understanding of your specialty's impact on patient care. Clinical experiences should be included in your training plan and you may be asked to help organise your experiences. Reflections and observations from your experiences may help you to advance your practice and can be used to develop evidence to demonstrate your awareness and appreciation of your specialty.
Activities
- Observe a time-point analysis as part of a stability study.
- Observe a HEPA filter integrity assessment.
- Observe piped medical gas testing.
Academic content (MSc in Clinical Science)
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
On successful completion of this module the trainee will be able to:
- Discuss the role of the Clinical Scientist in Quality Control in ensuring the safety of the patient.
- Apply integrative knowledge of pharmaceutical microbiological analytical techniques and instruments.
- Demonstrate extended understanding of pharmaceutical chemical analytical techniques and instruments.
- Apply integrative knowledge of techniques and equipment used in the monitoring of pharmaceutical cleanroom environments.
- Critically evaluate the quality of medicinal products, including raw materials, licensed and unlicensed products, ‘specials’, IMPs, medical and surgical devices, and medical gases.
- Describe the process of writing a stability protocol, considering method suitability and validation.
- Demonstrate a critical awareness of the process for investigating questionable laboratory results, out of specification and out of trend data.
Indicative content
- Apply integrative knowledge of pharmaceutical microbiological analytical techniques and instruments.
- Total viable count testing (membrane filtration and plate count)
- Absence of specific pathogens
- Endotoxin and pyrogen testing
- Sterility testing
- Demonstrate extended understanding of pharmaceutical chemical analytical techniques and instruments.
- Qualitative test tube reactions
- Limit tests
- Volumetric analysis
- Gravimetric analysis
- Refractometry
- Melting point
- Polarimetry
- Spectroscopy – ultraviolet (UV)/visible
- Spectroscopy – infrared (IR)
- Spectroscopy – atomic absorption
- pH
- Conductivity
- Liquid particle counting
- Solid dose form analysis
- Hardness
- Friability
- Disintegration
- Dissolution
- Thin-layer chromatography (TLC)
- High-performance liquid chromatography (HPLC)
- Gas chromatography (GC)
- Mass Spectrometry
- Apply integrative knowledge techniques and equipment used in the monitoring of pharmaceutical cleanroom environments.
- Pressure differentials
- Non-viable particle counting
- Room air change rates
- Air flows
- Filter integrity testing (DOP)
- Active air samples
- Contact plates
- Settle plates
- Finger dabs
- Swabs
- Operator and process validations
- Critically evaluate the quality of medicinal products, including raw materials, licensed and unlicensed products, ‘specials’, IMPs, medical and surgical devices, and medical gases.
- Describe the process of writing a stability protocol, considering method suitability and validation.
- Standards and guidance
- Demonstrate a critical awareness of the process for investigating questionable laboratory results, out of specification and out of trend data.
- Equipment calibration
- IQC/EQA