Module information
Module details
- Title
- Production
- Type
- Specialist
- Module code
- S-PS-S3
- Credits
- 10
- Phase
- 3
- Requirement
- Compulsory
Aim of this module
In this module students will consolidate their experience of the production processes, equipment and systems that contribute to the provision of high-quality, safe pharmaceutical products. This module will provide an understanding of the role of the clinical pharmaceutical scientist in pharmaceutical production within the wider area of pharmaceutical quality assurance and patient safety.
Work-based content
Training activities
| # | Learning outcome | Training activity | Type | Action |
|---|---|---|---|---|
| # 1 | Learning outcome 2,4,6 |
Training activities
Critically appraise a plan for the development of a new product including:
|
Type DTA | Action View |
| # 2 | Learning outcome 1,2,3,4,5,6 |
Training activities
Critically appraise a plan for product validation activities for a new product or process change |
Type DTA | Action View |
| # 3 | Learning outcome 2,6 |
Training activities
Evaluate the departments ongoing stability testing strategy against regulatory guidance and suggest improvements |
Type DTA | Action View |
| # 4 | Learning outcome 1,3,5,6 |
Training activities
Perform the manufacture of at least two products of differing dosage form, including one non-sterile product |
Type ETA | Action View |
| # 5 | Learning outcome 4,6 |
Training activities
Complete the supplier approval process for the following:
|
Type ETA | Action View |
| # 6 | Learning outcome 1,3,6 |
Training activities
Devise or critically appraise a troubleshooting matrix for the process of generating water for injection Suggest improvements where appropriate |
Type DTA | Action View |
| # 7 | Learning outcome 1,3,5,6 |
Training activities
Distribute a product Complete the required documentation and evaluate the recall process Suggest improvements where appropriate |
Type DTA | Action View |
| # 8 | Learning outcome 1,3,4,6 |
Training activities
Audit the process for material release and make recommendations for actions including:
|
Type DTA | Action View |
| # 9 | Learning outcome 1,3,5,6 |
Training activities
Audit the process for product release and make recommendations for actions |
Type DTA | Action View |
| # 10 | Learning outcome 1,3,6 |
Training activities
Evaluate a range of recent deviation reports and associated CAPAs applied |
Type ETA | Action View |
| # 11 | Learning outcome 1,2,3,4,5,6 |
Training activities
Complete a product quality review. Identify suggestions to improve practice and feedback the outcome to the wider team. |
Type DTA | Action View |
Assessments
Complete 2 Case-Based Discussions
Complete 2 DOPS or OCEs
Direct Observation of Practical Skills Titles
- Perform a manufacturing process.
- Perform a filter integrity test.
- Collect sample(s) from a manufacturing process for QC testing.
- Collect water for injection sample(s) for QC testing.
- Clean mixing equipment which is shared between different products.
- Provide training/assess understanding or competence.
Observed Clinical Event Titles
- Discuss new product requirements with an end user/requestor.
- Provide advice in response to a customer query.
- Present audit finding and recommendations at a quality meeting.
Learning outcomes
| # | Learning outcome |
|---|---|
| 1 | Describe the working practices of pharmaceutical production. |
| 2 | Apply the principles of good manufacturing practice (GMP) to the development of new products. |
| 3 | Perform a range of manufacturing activities, using specialist equipment, in accordance with requirements for GMP and pharmaceutical quality management systems. |
| 4 | Apply the principles of supplier approval and quality assessment to evaluate a range of starting materials and packaging components. |
| 5 | Perform activities to support safe storage and distribution of medicinal products applying the principles of Good Distribution Practice (GDP). |
| 6 | Apply the principles of quality risk management to the manufacturing process. |
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
- Attend a quality meeting.
- Observe clinical trial manufacture.
- Observe the release processes for starting materials, packaging components and finished products.
- Discuss the use of a product with regards to patient needs and experience with the Releasing Officer.
- Discuss with the Releasing Officer reasons for the rejection or recall of a product to appreciate the process followed and implications for patient safety and product availability.
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 production in ensuring the safety of the patient, particularly related to the manufacture of licensed and unlicensed pharmaceutical products and investigational medicinal products.
- Critically evaluate manufacturing processes including the principles of pharmaceutical formulation and processing.
- Apply integrative knowledge of the properties of APIs and excipients in pharmaceutical products.
- Explain the factors affecting formulation, stability and preservation of pharmaceutical product.
- Perform mathematical calculations relevant to pharmaceutical formulation.
- Describe the criticality of final packaging.
- Define critical control points and critical quality attributes of production processes.
- Demonstrate a critical awareness of the process for investigating problems during manufacturing.
Indicative content
Pharmaceutical formulation and processing
- Sources, preparation and purification of major drug substances and excipients
- Manufacture and storage of water for injection
- HTM 2030
- HTM 2031
- Formulation
- Stability studies
- Drug administration systems
- Specification development
- Presentation of the product in relation to its method of use and/or administration
- Production methods and equipment
- Equipment calibration
- Process validation
Principles of formulation
- Solutions and suspensions
- Semi-solids, creams and ointments
- Parenterals
- Tablets
- Capsules
- Eye preparations
- Specialised dose forms
- Powders
- Depot products
- Inhalations
- Transdermal
- Extemporaneous preparation
Properties of APIs and excipients in pharmaceutical products
- Thickeners
- Sweeteners
- Buffers
- Tonicity adjusters
- Preservatives
- Flavours
- Stabilisers
- Anti-oxidants
- Colouring agents
Principles of rheology (viscosity and fluid flow)
Key chemical and physical reactions involved in the preparation, stabilisation and degradation of medicinal products
- Solubility, dissolution
- Ionisation, deionisation of water and conductivity
- pH and acid-base reactions
- Precipitation, salting out and flocculation
- Complexation
- Redox reactions (oxidation, reduction, redox potentials)
- Partitioning and phase separation
- Thermal issues, boiling point, melting point and volatilisation/vapours
- Thermolabile degradation/effects of temperature
Criticality of final packaging
- Patient compliance
- Container types and closures
- Product protection
- Route of administration
- Labelling
Mathematical principles and calculations for pharmaceutical sciences
- Buffering and related calculations
- Dilutions and dose adjustments
- Tonicity adjustments