Program Overview

University of Kent Program Information

The University of Kent offers a wide range of programs for undergraduate and postgraduate students.

Courses

• Undergraduate courses
• Postgraduate courses
• Foundation courses
• Apprenticeships
• Part-time and short courses

Fees and Funding

• Tuition fees
• Scholarships
• Funding your studies
• Student finance
• Cost of living support

Why Study at Kent

• Student life
• Careers and employability
• Student support and wellbeing
• Our locations
• Placements and internships
• Year abroad
• Parents
• Schools and colleges

International

• International students
• How to apply
• International scholarships
• Your country or region
• Your accommodation
• English Language requirements
• Pre-sessional courses
• University of Kent International College
• Applicant FAQs

Research

• Research strengths
• Research centres
• Research impact
• REF 2021
• Research and Innovation Support
• Work with our experts

Research Institutes

• Durrell Institute of Conservation and Ecology
• Institute of Cyber Security for Society
• Institute of Cultural and Creative Industries
• Institute of Health, Social Care and Wellbeing

Research Students

• Graduate and Researcher College
• Research degrees
• Find a supervisor
• How to apply
• PhD funding

Partner with Us

• Work with our experts
• Employ our graduates
• Engage with us
• Apprenticeships
• Hire our facilities
• Press Centre

GxP (Business Option) Module Information

Module Delivery Information

• Location: Medway
• Term: Autumn Term, Summer Term, Year (Non Standard)
• Level: 5
• Credits (ECTS): 15 (7.5)
• Current Convenor: Winifred Nyinoh

Overview

A synopsis of the curriculum:

• Basic Introduction to GxP
• Good Laboratory Practices (GLP)
• Good Manufacturing Practices (GMP)
• Reasons for validation
• Non-Conformance investigations and Reporting
• Good Aseptic Practices (GAP)
• Good Clinical Practices (GCP)
• Risk Based Compliance
• Quality Audits

Details

• Contact hours: 120 hours
• Private Study Time: 30 hours
• Total Learning Time: 150 hours

Method of Assessment

• Portfolio, two coursework assignments and exam
• Weighting:
  • 2 Essay Assignments 40% (20% each)
  • Portfolio 20% - composed of 5 individual assignments where topics are applied to the workplace
  • Exam (40 minutes) 40% - MCQs
• The pass mark for each individual assessment is 40%. All assessments must be passed in order to pass the module.

Indicative Reading

• MHRA (2007) Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Pharmaceutical Press.
• Anna Lunden (2008) The GMP Handbook. Lunden-Ellow.

Learning Outcomes

The intended subject specific learning outcomes:

• Demonstrate a critical understanding of well-established pharmaceutical/industry GxP requirements.
• Apply the relevant GxP legislation that is applicable to their own work environment, to well defined contexts.
• Apply the relevant tools and established techniques used in GxP risk-based compliance to a work-related activity, producing a summary report and recommendations.
• Demonstrate knowledge and critical understanding of audits in quality management and carry out an internal compliance audit in accordance with the legislative requirements.
• Complete a non-conformance investigation and deviation report to a reasonable level, using the appropriate investigation techniques.

The intended generic learning outcomes:

• Analyse, evaluate and correctly interpret data.
• Present and communicate data effectively.
• Obtain and use information from a variety of sources as part of self-directed learning.
• Display time-management and organisational skills within the context of self-directed learning.

Notes

1. Credit level 5. Intermediate level module usually taken in Stage 2 of an undergraduate degree.
2. ECTS credits are recognised throughout the EU and allow you to transfer credit easily from one university to another.
3. The named convenor is the convenor for the current academic session.

Key Information

• Year: 2025 to 2026
• Pre-requisites: None
• Restrictions: None