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LSC-30112 - Module Specification
School of Life Sciences
Faculty of Natural Sciences

For academic year: 2025/26 Last Updated: 04 December 2025

LSC-30112 - Current Good Manufacturing Practice (cGMP)
Coordinator: Tina Dale Tel: +44 1782 671660
Lecture Time: See Timetable...
Level: Level 6
Credits: 15
Study Hours: 150
School Office: 01782 734414

Programme/Approved Electives for 2025/26

None

Available as a Free Standing Elective

No

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2025/26

In recent years the emergence of personalized medicine and regenerative medicine therapies has driven a need for the associated advanced manufacturing capabilities. This module will introduce the fundamental requirements and regulation for current Good Manufacturing Practice (cGMP), supporting development of these specialized skill sets. This module will provide an understanding of current Good Manufacturing Processes (cGMP) for the biomanufacturing of advanced biological therapies, including the facility, process, quality, staffing, and regulatory compliance needs.
The module will be delivered with a combination of lectures and workshop sessions.

Aims
This module will provide an understanding of current Good Manufacturing Processes (cGMP) for the biomanufacturing of advanced biological therapies, including the facility, process, quality, staffing, and regulatory compliance needs.

Intended Learning Outcomes

Identify the biomanufacturing needs for advanced therapies.: 2
Critically analyse how regulatory standards and quality management processes contribute to product safety and efficacy.: 1,2
Compare contrasting engineering solutions for achieving the required standards.: 2
Formulate specific recommendations for improvements for identified examples where the required cGMP standards were not met.: 1
Design a cGMP compliant solution, including limited supporting quality management documentation, for a theoretical/potential advanced biological therapy.: 2

Study hours

Active Learning
10 x 1 hour lectures
10x 2 hour workshops building on lecture content and supporting portfolio assessment
1x2 hour tutorial on content/structure of the portfolio
3 hour visit to Guy Hilton Cell Therapy suite
4 hour visit to Charles River labs
3 hour formative poster feedback session
Independent study hours to be spent:
Further independent reading on the topics introduced in the lectures: 50 hours
Preparing your assessment 1 poster: 12 hours
Working on your portfolio content: 46 hours

School Rules

None

Description of Module Assessment

1: Poster weighted 30%
Poster detailing recommendations to resolve failure to meet cGMP requirements
Students will identify an example of bad practice from media sources where GMP requirements were not adhered to and will suggest modifications to cGMP procedures required to avoid this situation arising again. Students will produce an electronic poster covering the failure, the consequences and their proposed solution(s). A formative feedback opportunity including peer feedback will be offered.

2: Portfolio weighted 70%
Portfolio covering aspects of the biomanufacturing requirements for a selected regenerative medicine technology
Students will create a portfolio (max 3500 words) with sections reflecting each aspect of the manufacturing requirements for a selected regenerative medicine product. Sections will include identifying the regulatory status of the product, identifying material requirements, designing and identifying facility and engineering requirements, defining staffing requirements, processing, and specifying quality assurance/management processes including associated document examples. Supported with weekly tutorials related to the various sections, the portfolio will be submitted towards the end of the semester.

The University undertakes a continuous review of its teaching and research provision to ensure programmes are of a high quality and changes may be made to modules where it is necessary and reasonable to do so. Please be aware that minor changes to modules, such as a change to an individual assessment, can occur up until enrolment, although we endeavour to give you as much notice as possible of any changes. Details about the circumstance in which changes are made to programmes can be found in the Student Agreement, available at: https://www.keele.ac.uk/legalgovernancecompliance/governance/actcharterstatutesordinancesandregulations/studenttermsconditions/

Last Updated: 04 December 2025