Module information
Module details
- Title
- Introduction to Regulation and QA
- Type
- Rotation
- Module code
- S-PS-R1
- Credits
- 10
- Phase
- 1
- Requirement
- Compulsory
Aim of this module
This module will introduce trainees to the principles of regulation and quality assurance as applied to practice in Pharmaceutical Sciences. Trainees will appreciate the legislation and guidance which underpins the regulation of services and be introduced to the roles, responsibilities and processes which assure high quality services and safe patient care.
Work-based content
Training activities
| # | Learning outcome | Training activity | Type | Action |
|---|---|---|---|---|
| # 1 | Learning outcome 1,2,3,6 |
Training activities
Attend a departmental meeting where quality assurance issues are discussed and reflect on the meeting |
Type OTA | Action View |
| # 2 | Learning outcome 1,2,3,6 |
Training activities
Shadow a local quality assurance lead and reflect on their role |
Type OTA | Action View |
| # 3 | Learning outcome 1,2,3,6 |
Training activities
Shadow a regional quality assurance lead and reflect on their role |
Type OTA | Action View |
| # 4 | Learning outcome 1,2,3,6 |
Training activities
Observe a quality audit and reflect on the process |
Type OTA | Action View |
| # 5 | Learning outcome 1,2,3,6 |
Training activities
Follow the process for introducing a change and reflect on the process |
Type OTA | Action View |
| # 6 | Learning outcome 1,3,4,6 |
Training activities
Explore a new national policy or guidance and reflect on the impact on the department |
Type OTA | Action View |
| # 7 | Learning outcome 1,3,5,6 |
Training activities
Review the effect of Good Practice (GXP) guidance andreflect on how this guides practice |
Type OTA | Action View |
| # 8 | Learning outcome 1,2,3,6 |
Training activities
Attend a meeting where organisation wide governance issues are discussed and reflect on the meeting |
Type OTA | Action View |
| # 9 | Learning outcome 1,2,3,6 |
Training activities
Follow the process for reporting and investigating an incident logged in the organisation incident reporting system and reflect on the process |
Type OTA | Action View |
| # 10 | Learning outcome 1,2,3,6 |
Training activities
Follow the process for the quality assurance of the procurement of licensed and unlicensed medicines and reflect on the process |
Type OTA | Action View |
Assessments
Complete 1 Case-Based Discussion
Complete 1 DOPS or OCE
Direct Observation of Practical Skills Titles
- Carry out hand hygiene prior to entering a clean area.
Observed Clinical Event Titles
- Discuss the elements of a quality management system and its relevance to your role.
- Communicate a change to the wider team.
Learning outcomes
| # | Learning outcome |
|---|---|
| 1 | Explore the contribution ofregulation and quality assurance of Pharmacy Technical Services to patient care. |
| 2 | Identify the roles and relationships of the multidisciplinary team involved in the regulation and quality assurance of Pharmacy Technical Services. |
| 3 | Describe the working practices required for the regulation and quality assurance of Pharmacy Technical Services. |
| 4 | Examine the impact of changes in regulation and quality assurance processes on Pharmacy Technical Services. |
| 5 | Review the effect of legislation and guidance on Pharmacy Technical Services. |
| 6 | Compare and contrast the practices required to regulate and quality assure Pharmacy Technical Services with other areas of pharmaceutical sciences. |
Clinical experiences
Activities
There is no clinical experiential learning associated with this module.
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 Pharmaceutical Sciences in ensuring the safety of the patient, related to pharmaceutical preparation, manufacture and quality assurance.
- Evaluate error reports relating to pharmaceutical preparation and the impact that these have had on pharmacy regulations and guidance.
- Critically evaluate the application of regulatory controls to pharmaceutical technology and quality assurance.
- Critically appraise the principles of quality assurance and EU good manufacturing practice (GMP) and quality management systems.
- Critique documentation relating to pharmaceutical preparation, manufacturing, quality assurance and quality control.
- Discuss the health and safety aspects of pharmaceutical technology and quality assurance.
- Critique the requirements for outsourcing and purchasing of pharmaceutical products.
Indicative content
- Discuss the role of the Clinical Scientist in Pharmaceutical Sciences in ensuring the safety of the patient, related to pharmaceutical preparation, manufacture and quality assurance.
- Evaluate error reports relating to pharmaceutical preparation and describe the impact that these have had on pharmacy regulations and guidance.
- Devonport Incident (1972) – Clothier Report, then Rosenheim report (1973)
- Manchester Incident (1994) – Farwell Report
- Breckenridge Report (1976)
- London (glucose) Incident (2006)
- Intrathecal Incidents – Woods Report (2001)
- Neonatal PN Report (2011)
- Royal Surrey Incident – Toft Report (2012)
- Critically evaluate the application of regulatory controls to pharmaceutical technology and quality assurance.
- 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
- European Commission Directives
- Statutory Instruments
- Medicines Act leaflets
- Clinical Trials directive and UK implementation
- Quality management standards (e.g. ISO9000)
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Specifications and standards (e.g. British Pharmacopoeia)
- Official reports (e.g. Farwell, Clothier, Rosenheim) of relevance and importance
- Yellow Cover Documents
- Critically appraise the principles of quality assurance and EU GMP and quality management systems.
- Pharmaceutical Quality Systems
- Risk assessment
- Data Integrity
- Product Quality Review
- Pharmaceutical Quality Systems Review
- Validation and Validation Master Plans
- Change Control
- Specifications and Standards
- Errors and deviations
- CA/PA
- Root cause analysis
- Capacity and contingency planning
- Management of defects and recalls
- Maintenance of facilities and equipment
- Audit and self-inspection
- Contamination control strategies
- Governance and controls assurance, risk management and critical point control analysis
- Critique documentation relating to pharmaceutical preparation, manufacturing, quality assurance and quality control.
- Document design principles
- Document control
- Data Integrity
- Discuss the health and safety aspects of pharmaceutical technology and quality assurance.
- COSHH
- Health and Safety at Work Act
- Critique the requirements for outsourcing and purchasing of pharmaceutical products.