MSc Pharmaceutical Technology and Quality Assurance

Year of entry: 2022

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Course unit details:
Pharmaceutical Risk Mgmt and the role of the Qualified Person

Unit code PHAR61920
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

  • Applying to become a QP
  • Pharmaceutical law and administration
  • Role and responsibilities of the QP
  • Quality Management systems
  • Mathematics and statistics used by the QP
  • Methods of microbiological testing
  • Role of the QP in Good Laboratory Practice
  • Control of pharmaceutical packaging
  • Control of active pharmaceutical ingredients
  • Role of the QP in clinical trials 

 

  • Overview of Pharmaceutical Risk Management and Audit
    • Roles of bodies involved
    • Links between National, Trust and Departmental agendas
    • Overview of legislation and standards
    • Relevant technical standards
    • Purchasing for Safety

 

  • Introduction to Risk Assessment and Management
    • Definitions
    • Types of Risk/Evidence of Risk/weighting Risk
    • Risks to product/Patients/staff/environment
    • Control of Risk - Minimising Risks - Transfer of Risk 

 

  • Introduction to Pharmaceutical Audit
    • Aims and role of Audit/definitions
    • The Audit Cycle
    • Types of Audit, Internal/External/Inspection/Review
    • Quality Systems within Pharmacy Services eg ISO 9002, Specials etc. 

 

  • Audit Techniques
    • Attributes of the auditor
    • Tools of the Auditor (Vertical/Horizontal Audit/Document Based/Problem Oriented/Random)
    • Compliance Monitoring/Assessment/Grading 

 

  • Risk Assessment Techniques
    • Data handling and Statistical Calculations
    • Reports and Documentation

 

  • Risk Reduction and Safe Systems of Work
    • Design of systems for Good Practice
    • Principles and key elements of good practice
    • Performance Indicators/Capacity planning

Aims

This unit develops the student’s understanding of the role and professional duties of the QP within the NHS and industry environments. The unit delivers core knowledge required on the pharmaceutical law and regulations applicable to the manufacture of pharmaceuticals and provides students with an appreciation of the process required to become a registered QP in the UK.

Students learn the skill to apply all the elements of the QP study guide in their workplace. With sufficient practical experience after the unit, students should have the skills to be assessed for formal QP status.

The unit will provide students with the core knowledge to identify, assess and mange risks within the pharmacy technical environment and to carry out quality assurance audits of services and service providers within this field. The unit will incorporate the relevant national standards and legislation that apply within this area of practice and introduce them to the use of common risk management tools and strategies used in pharmaceutical environments.

Teaching and learning methods

  • A teaching block including workshops and practicals.
  • E-learning: evidence-based learning supported by course notes, audio lectures and discussion boards.

Knowledge and understanding

  • Demonstrate and in-depth knowledge of the role and professional duties of the Qualified Person as defined by EU law.
  • Interpret the current pharmaceutical law and regulations and apply them to the manufacture of pharmaceuticals.
  • Apply the extensive body of knowledge required by the QP to the workplace.
  • Critically analyse processes and systems to assure the quality of pharmaceuticals and maintain patient safety.
  • Undertake a proactive approach in applying the theory of risk management to patient care.
  • Demonstrate a working knowledge of the relevant standards and legislation required for risk management.
  • Critically evaluate compliance with national standards using the audit and risk assessment processes.
  • Demonstrate the skills and in-depth knowledge required to design and conduct audit and implement action plans.

Intellectual skills

  • Follow regulatory standards and guidance.
  • Critically review processes and procedures during audit.

Practical skills

  • Carry out thorough risk assessments using a variety of tools and techniques.
  • Identifying different types of risk.
  • Suggesting and implementing risk reduction measures.
  • Applying statistical methods to determine robustness or validity of data.

Transferable skills and personal qualities

  • Use effective negotiation skills.
  • Communicate difficult decisions.
  • Maintain a pragmatic approach during challenging debates.

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Written assignment

3,000 words

Feedback is provided 3 weeks after submission

Feedback methods

Provisional marks and feedback for coursework returned within 15 working days.

Exam marks and final marks returned after ratification at exam board. 

Study hours

Scheduled activity hours
Lectures 22
Independent study hours
Independent study 128

Teaching staff

Staff member Role
Alison Beaney Unit coordinator

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