VALD08003 2019 Validation for Regulatory Compliance

General Details

Full Title
Validation for Regulatory Compliance
Transcript Title
Validation for Regulatory Comp
N/A %
Subject Area
VALD - Validation
MENG - Mech. and Electronic Eng.
08 - NFQ Level 8
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Fiona Donovan
Programme Membership
SG_EQLTY_K08 201900 Bachelor of Science (Honours) in Engineering in Quality Management and Tech

An overview of the regulatory requirements for validation activities focused on the pharmaceutical, biopharmaceutical, medical device and food sectors.

Learning Outcomes

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


Explain Validation Categories


Discuss the importance of Validation in Industry


Generate a User Requirement Specification for a new piece of equipment or system.


Interpret the Regulatory requirements as they apply to the different categories of validation


Write a Validation protocol- DQ,IQ OQ or PQ


Apply the concept of risk management to the different areas of validation

Teaching and Learning Strategies

Lectures delivered online. Recordings made available immediately after lectures. Supporting lecture notes available.

Module Assessment Strategies

Module will be assessed by using a combination of moodle quizzes, long answer and short answer questions and research based assignments.

Repeat Assessments


Indicative Syllabus

1. History of Validation requirements and how Validation and GMP are linked.

2.  The Regulatory Authorities and how they regulate.

3. Specific regulatory requirements- Eudralex, ICH guidance docs- Q7,Q8,Q9 and Q10, FDA CFR's

4. Overview of all relevant documentation/Contents of each- Validation master plan, Validation Summary reports, User Requirement specifications, Risk Assessments, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification.

5. Cleaning Validation requirements- Pharma, Bio-pharma, Medical device and Food sectors

6. Validating a new Cleanroom- specific tests at each stage of the validation process

7. Software Validation requirements

8. Sterilisation Validation requirements- Moist heat sterilisation 

9. Analytical Method Validation: Importance of, specific factors to be considered

10. Overview of other related topics such as Calibration, Preventive Maintenance and Change Control.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
30 %
End of Semester / Year Formal Exam
70 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment Continuous Assessment UNKNOWN 15 % Week 5 1,2,4,5
2 Essay Assignment Continuous Assessment UNKNOWN 15 % Week 9 3,5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam 2.5 hour written exam. Final Exam UNKNOWN 70 % End of Term 1,2,3,4,5,6

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite online lectures 3 Weekly 3.00
Tutorial Distance Learning Suite online tutorials 1 Weekly 1.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite lectures 3 Weekly 3.00
Tutorial Distance Learning Suite tutorials 1 Weekly 1.00
Total Part Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Required Reading
2017-01-06 Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
ISBN 0857112856 ISBN-13 9780857112859

Commonly known as the Orange Guide, this book remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines.

Required Reading
2007-09-25 Validation of Pharmaceutical Processes, Third Edition CRC Press
ISBN 0849370558 ISBN-13 9780849370557

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

Required Reading
1998-04-30 Validation Fundamentals CRC Press
ISBN 1574910701 ISBN-13 9781574910704

Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. Packed with tools to help you follow the logic of the validation process, the book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and other topics impacting the qualification of a system, equipment, and/or process.

Module Resources

Non ISBN Literary Resources

Eudralex Volume 4 (available online)

Journal Resources


Other Resources


Additional Information