1. Clinical Pharmaceutical Science
Scientist Training Programme (STP)

2. What is STP?
Postgraduate entry programme leading to more senior scientific roles
Employed by NHS Trust for duration of training
National recruitment and placement
Part of the Modernising Scientific Careers Programme
The MSC programme ensures that the healthcare science workforce will be fit to
respond to future scientific and technological advances and to meet the demographic,
epidemiological and financial challenges facing the health and social care system.
Very simply, MSC is about making sure that those working in healthcare science can deliver
quality services to patients and continue to play a major role in healthcare

3. Programme Structure

4. Completion of training programme
STP Trainee Journey
Completion of training programme
REGISTRATION
University
Work Base (NHS Trust)
Assessment Programme
(OLAT, OSFA)

5. Themed Healthcare Science Divisions

6. Clinical Pharmaceutical Scientists work in 4 areas of technical pharmacy
Quality Control and Quality Assurance
Production Units
Aseptic Dispensing and Preparation
Radiopharmacy
Healthcare Science staff in Clinical Pharmaceutical Science work to ensure the medicines a patient receives are SAFE and FIT FOR PURPOSE

7. Quality Control and Quality Assurance
We can’t always detect a problem with a medicine until it’s too late
Potentially very hazardous to patient
Element of trust
Cannot test the whole batch

8. Good Manufacturing Practice (GMP) 10 Basic Rules
Having detailed written instructions before any job is started
Following instructions exactly
Ensure the correct products and materials are being used
Ensure that the correct equipment is being used and that it is clean
Prevent contamination and mix up
Always guard against labelling errors
Always work accurately and precisely
Keep things clean and tidy
Be on the lookout for mistakes, errors, and bad practices and report them immediately
10) Make clear and accurate records of what has been done and the checks carried out

9. Quality Control and Quality Assurance
Newcastle upon Tyne Hospitals (NUTH)
Manufacture Specials
Traditional Pharmaceuticals
Advanced therapies
Radiopharmaceuticals
MHRA Regulate
Manufacture IMP’s
Prepare medicines for use within NUTH
Parenteral Nutrition, chemotherapy etc.
EL auditors Regulate
Production
QAQC

10. STP activities – Quality Control and Quality Assurance
Packaging quality assessments
Quality Management System reviews and updates
Qualification of equipment
Analytical Method Development
Shelf life literature review and assessments
Audits
Analytical and Microbiological testing
Product Quality Review
Investigations and root cause analysis
Change Control

11. Production FACILITIES – EQUIPMENT
What is thought process in selecting a new item of production equipment
e.g replacing an old LAFC or Isolator
What factors need to considered?
Space – How will it fit into intended space
Services – How will it connect to power / water/ gas /other
Who is responsible for connecting to services
Training of staff
Specification and qualification
User Requirement Specification
How to decide which features functions are essential and which are desirable DQ
IQ/ OQ/PQ
Re Qualification – Servicing / Engineers calibration certificates
Consider something as simple as a measuring cyclinder in a dispensary. What should this be constructed of etc, grade A glassware/ marked with government stamp of approval. Or installation of a new fridge – what functionality might you want to include – alarms, remote monitoring. How would you qualify?

12. STP Activities - Production
General Manufacture
Label Design
Validations
Stock checks
Production Planning
Investigation reporting
Planned Preventative Maintenance
New Product Introduction
MRS
Microbiology Monitoring System
For environmental monitoring compliance

13. MRS Microbiology Monitoring System
Aseptic Services
PARENTERAL NUTRITION
Indications
Patients requiring PN
Peripheral vs Central
Consider constituents
Costs
Risks
Formulation
-Complex
Nutritional requirements vs Formulation stability
Order of mixing – Calcium /Phosphate/ Divalent ions interactions
Administration
Filtration
Duration
Patients - Four broad groups of patients
premature babies
may have poorly developed gut/liver/enzyme systems
patients with cancer (esp children)
may not feel like eating, or gut not working due to chemo
long term patients (eg Crohn’s, short bowel)
may need to be on PN for months or rest of life
short term patients (eg bowel surgery)
may only require 4-14 days
Peripheral vs central line
short term use - long terms use
Glucose concentration, thrombophlebitis – osmolality
Central line infection – consequences
Constituents
Costs of treatment
Risks – contamination incidents – Farwell, ITH etc etc
Complex formulation
AAs, Glucose, Electrolytes,Trace elements, Vitamins – Fat and water soluble
Nutritional requirements – can be difficult to match patients exact nutritional requirements due to formulation stability limitations. Consider All in one bags are EMULSIONS Glucose fat ratios etc etc
Nutritional needs can be very individual – consider a burns patient, neonates with little or no reserves
Mixing – Interactions precipitation- inorganic vs organic phosphate – can’t see precipitate in fat bags
vitamin degradation – consequence to patient – multilayer bags
Administration
Commonest problems are:
metabolic
catheter infections
But death has occurred in patients due to
precipitates
particles
bacteria
Filters remove
particles, ppts, bacteria (except lipid filters), fungi & air.
- Filters For non-lipid PN, use 0.2m filter
Fat globs are m diam, so use 1.2 m filter for emulsions
(C. Albicans is m diam)
deaths in US
periph AIO mixtures with Calc Phos ppt
diffuse microvascular pulm emboli
camouflaged by lipid
FDA recommend filters as result of this
Typical ITU patient may get 3 mill particles >2 micrometres in 24 hours.
cf 3kg infant 37,000 particles >2 microm
Post mortem lung sections of long-term IV receivers show granulomata with cellulose fibres.
MRS
Microbiology Monitoring System
For environmental monitoring compliance

14. STP Activities - Aseptic Services
Staff Training
Dispensing
Process Validation
Written validation protocols
Documentation review and updates
Change Control
Investigation and Root cause analysis
MRS
Microbiology Monitoring System
For environmental monitoring compliance

15. Radiopharmacy Pharmaceutical
A radiopharmaceutical has two essential components:
A pharmaceutical, something that goes to the part of the body you want to look at
tagged on to something that emits radiation – a radionuclide
Pharmaceutical

16. MRS Microbiology Monitoring System
Radiopharmacy
What are radiopharmaceuticals used for?
Range of clinical indications
Diagnostic Radiopharmaceuticals
Therapeutic Radiopharmaceuticals
Radiopharmacy is an interdisciplinary science which applies physical and biological sciences.
Applications include:
Production and properties of the radionuclide
Incorporation into a carrier
Formulation
Quality control
Adverse effects
Drug interactions
MRS
Microbiology Monitoring System
For environmental monitoring compliance

17. Radiopharmacy – Patient Pathway
Radionuclide Production
Patient dose preparations
Interpretation
Patient Injection and Scanning
MRS
Microbiology Monitoring System
For environmental monitoring compliance

18. Radiopharmacy – Day to day
Implementing improvements
Dispensing
Staff training
Documentation review and updates
Validation of new equipment
Investigations
Routine Calibration of equipment
Radiation safety
MRS
Microbiology Monitoring System
For environmental monitoring compliance

19. Rotations – Clinical Pharmaceutical Science
Year 1 Rotations
Quality Assurance & Quality Control
Production
Aseptic Preparation
Radiopharmacy
Years 2 and 3 Specialism
Quality Assurance & Quality Control 2
Production 2
Aseptic Preparation 2
Radiopharmacy 2

20. DOPs (Direct Observation of Practical Skills)
Assessments
DOPs (Direct Observation of Practical Skills)
Manual Skills learnt and demonstrated
CBDs (Case Based Discussions)
Understanding and integration of knowledge from various sources
Competencies
Skills/Knowledge/Understanding
OCEs (Observed Clinical Events)
Performance

21. Competency Examples
5 competencies covered in the completion of 1 MSc assignment!

22. Competency Examples What? Why? When things go wrong? Learning Outcome:
Observe, assist and where appropriate perform, under supervision, a range of processes and procedures in accordance with local practice in order to manufacture products safely.
What?
Why?
When things go wrong?

23. Elective

24. Potential roles upon completion
• Qualified Person
• Medical Gas Testing
• Radionuclide Radiotherapy
• Pharmaceutical Microbiology
• Pharmaceutical Stability Testing
• Pharmaceutical Formulation Science
PET Radiochemistry

25. Any Questions?