CHEN40120 Biopharmaceutical Industry Regulation and Management

Academic Year 2022/2023

This module will provide a high level overview of the regulatory environment in which biopharmaceutical engineering professionals must operate. Topic covered within this module include ; principles of cGMP, regulations and regulatory bodies, self-inspection programmes and audits, roles and responsibilities
and documentation and change control. This module will be delivered by industrial experts from DPS Engineering.

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Curricular information is subject to change

Learning Outcomes:

On completion of this module students should be able to:

1. Define the principal implications of cGMPs and understand their specific application throughout the product lifecycle
2. Understand the regulatory bodies and their guidelines that govern the biopharmaceutical industry.
3. Outline procedures for managing compliance based on the cGMPs for the 21st Century initiative

Student Effort Hours: 
Student Effort Type Hours


Autonomous Student Learning




Approaches to Teaching and Learning:
Case-based studies 
Requirements, Exclusions and Recommendations

Not applicable to this module.

Module Requisites and Incompatibles
Not applicable to this module.
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade In Module Component Repeat Offered
Continuous Assessment: Various assignments over the semester Varies over the Trimester n/a Graded No



Carry forward of passed components
Resit In Terminal Exam
Spring No
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, post-assessment

How will my Feedback be Delivered?

Not yet recorded.

Name Role
Professor Niall Barron Lecturer / Co-Lecturer
John Milne Lecturer / Co-Lecturer