REGU09021 2019 Biopharmaceutical Regulation and Compliance

General Details

Full Title
Biopharmaceutical Regulation and Compliance
Transcript Title
Biopharmaceutical Regulation a
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
09 - NFQ Level 9
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Sharon Barrett, Stephen Daly
Programme Membership
SG_SBPRO_M09 201900 Master of Science in Bioprocessing

This module is taken by Masters students in Bioprocessing. It aims to provide students with an understanding of the risks associated with biopharmaceutical processing and how regulations translate into the manufacturing environment. It also provides students with and understanding of the main validation concepts as well as the application of continuous improvement initiatives in bioprocessing.

Learning Outcomes

On completion of this module the learner will/should be able to;


Demonstrate an understanding of the global regulatory framework for biotechnology derived products


Understand how the nature and production of biotechnology products affects quality, safety and efficacy


Differentiate the applications of EU & US regulations for biopharmaceutical marketing authorisations


Evaluate the regulatory requirements of equipment qualification, process validation, and life cycle management 


Appraise the principles of lean-six sigma, statistical process control and other current quality improvement initiatives.


Engage in and demonstrate independent learning as well as communicate effectively as an

Individual and as a member of a team

Teaching and Learning Strategies

This module can be taught using a combination of face to face and on-line lectures (if required). Integration of workshops and group learning will also be integrated into the module.  A range of Computer-Aided Learning (CAL) packages are also used to support this module (e.g. Moodle,Adobe Connect, Panopto, Camtasia). Students are provided with electronic materials for self-assessment and preparation for assessments/assignments. Self-directed, student-centred, independent learning is a core aspect through completion of module coursework.

Module Assessment Strategies

The assessment approach for this module will be a combination of a end of term exam as well as continuous assessment. The continuous assessment will include some of the following:
Enquiry based Projects, Assignments/mini projects including Viva/Presentation.
Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions

Repeat Assessments

Students will have opportunities to re-submit work or repeat the terminal exam as agreed with their lecturer

Indicative Syllabus


Overview of the EMA, FDA, and ICH.

Introduction to Clinical Trials and Drug Development (CTA, IMPD, IND)



TSE risks

Advanced Therapies



FDA & EU GMP regulations for pharma/biopharma manufacture



Validation Master Plan, validation life cycle, and risk management

Equipment Qualification,

Process & method validation

Cleaning and Viral Clearance


Quality Improvement Techniques

Lean manufacturing (6S, Kaizen), Six sigma implementation, DMAIC

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
60 %
End of Semester / Year Formal Exam
40 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ 1 Continuous Assessment Multiple Choice 10 % Week 5 1,2,3
2 MCQ 2 Continuous Assessment Multiple Choice 10 % Week 10 4,5
3 Mini Project Project Assignment 20 % OnGoing 1,2,3,4
4 Lean enquiry Project Project Group Project 20 % OnGoing 5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Exam Final Exam Closed Book Exam 40 % Week 15 1,2,3,4,5

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Lecture Theatre Lecture 2 Weekly 2.00
Total Full Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
2004-09-22 The Lean Six Sigma Pocket Toolbook: A Quick Reference Guide to 70 Tools for Improving Quality and Speed : A Quick Reference Guide to 70 Tools for Improving Quality and Speed McGraw Hill Professional
ISBN 0071441190 ISBN-13 9780071441193

A BUSINESSWEEK BESTSELLER Bestselling Lean Six Sigma author Michael George provides the first pocket guide for deployers of Lean Six Sigma The Lean Six Sigma Pocket Toolbook blends Lean and Six Sigma tools and concepts, providing expert advice on how to determine which tool within a "family" is best for different purposes. Packed with detailed examples and step-bystep instructions, it's the ideal handy reference guide to help Green and Black Belts make the transition from the classroom to the field. Features brief summaries and examples of the 70 most important tools in Lean Six Sigma, such as "Pull," "Heijunka," and "Control Charts" Groups tools by purpose and usage Offers a quick, easy reference on using the DMAIC improvement cycle Provides comprehensive coverage in a compact, portable format

Required Reading
2002-04-25 Lean Six Sigma McGraw-Hill
ISBN 0071385215 ISBN-13 9780071385213

Time and quality are the two most important metrics in improving any company's production and profit performance. Lean Six Sigma explains how to impact your company's performance in each, by combining the strength oftoday's two most important initiatives--Lean Production and Six Sigma--into one integrated program. The first book to provide a step-by-step roadmap for profiting from the best elements of Lean and Six Sigma, this breakthrough volume will show you how to: * Achieve major cost and lead time reductions this year * Compress order-to-delivery cycle times * Battle process variation and waste throughout your organization

Required Reading
2012-05-09 Process Validation in Manufacturing of Biopharmaceuticals, Third Edition CRC Press
ISBN 9781439850930 ISBN-13 1439850933

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Required Reading
2007-08-13 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9780470012444 ISBN-13 0470012447

Offers a comprehensive introduction to the principles and concepts of pharmaceutical biotechnology.

Module Resources

Non ISBN Literary Resources

See booklist

Journal Resources


URL Resources


Other Resources


Additional Information