General Details

Full Title
Transcript Title
N/A %
Subject Area
GMP - Good Manufacturing Practice
LIFE - Life Sciences
06 - NFQ Level 6
10 - 10 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Fiona Donovan
Programme Membership
SG_SGOOD_C06 201900 Higher Certificate in Science in Good Manufacturing Practice & Technology

Topics covered in this module include an introduction to validation principles and applications, validation documentation, risk assessments, Annex 15, FDA Validation requirements,  Analytical test method validation, Cleanroom validation, recalls and complaints, audits and aseptic processing. Upon completion, students will be able to practice these GMP principles in regulated industries.

Learning Outcomes

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


Demonstrate a good grounding in the concept of GMP, its regulatory basis and the critical role these GMP practices play in ensuring that pharmaceutical products and medical devices are consistently safe and effective, and are produced to high quality standards.


Demonstrate an appreciation for the importance and benefits of a disciplined approach to GMP in a regulated environment, including sterile product manufacture.


Demonstrate an understanding of equipment and analytical method validation.


Explain and illustrate the key requirements in a URS


Comprehend and explain the importance of risk assessment and it's link to validation


Describe key principles that ensure the validity of all data generated within a GMP environment.


Comprehend the roles of QA and QC within a Quality Management system

Teaching and Learning Strategies


Module Assessment Strategies


Repeat Assessments


Indicative Syllabus

Introduction to Validation.

Stages of validation & Risk Assessment.

Annex 15 requirements

Traditional approach versus QbD approach 

Annex 1. Manufacture of sterile products.

Coursework & Assessment Breakdown

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

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Debate/discussion forums Formative Assessment - % OnGoing 1,2,4,5,6,7
2 Assignments Coursework Assessment Assignment 40 % OnGoing 1,2,3,4,5,6,7

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 60 % End of Term 1,2,3,4,5,6,7

Part Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 4 Weekly 4.00
Total Part Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Required Reading
2015 Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 (the Orange Guide)
ISBN 085711171X ISBN-13 9780857111715

This is the ninth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by MHRA. Commonly known as the Orange Guide, it 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. The new 2015 edition incorporates all the significant updates and additions to the detailed European Community guidelines on GMP since the last edition, including the revised EU Guidelines on Good Distribution Practice. In addition, it contains new sections on: The Gold Standard for Responsible Persons MHRA Innovation Office The Application and Inspection process for new licences - "what to expect" MHRA Compliance Management and Inspection Action Group MHRA Risk-based inspection programme Naming Contract Quality Control (QC) laboratories GDP Quality Systems A new flow chart on registration requirements for UK companies involved in the sourcing and supply of active substances (ASs), to be used in the manufacture of licensed human medicines Building on the restructured contents and fresh redesign of the last edition, you'll find all the answers you need to stay informed.

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

Rules and Guidance for Pharmaceutical manufacturers and distributors 2007 (Orange Guide).

ICH Q9, Risk Management Process.

Journal Resources


Other Resources


Additional Information