VALD06001 2019 Validation Principles
Full Title
Validation Principles
Transcript Title
Validation Principles
Code
VALD06001
Attendance
N/A %
Subject Area
VALD - 0917 Validation
Department
MENG - Mech. and Electronic Eng.
Level
06 - Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Nolan, Fiona Donovan
Programme Membership
SG_EVALI_S06 201900 Certificate in Validation Technologies
SG_EVALP_E06 202300 Certificate in Validation Technologies with Project
Description
This module introduces the student to the area of validation. The student will learn the reasons behind the stringent validation requirements in the pharmaceutical, biopharmaceutical and medical device sectors. The student will become familiar with the actual regulatory requirements for validation activities and understand the expectations from both an EU and US regulatory point of view.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
1. Comprehend and discuss the reasons for strict regulatory requirements in relation to validation.
2.
2. Interpret the requirements of Eudralex Volume 4 Annex 15
3.
3. Understand the different stages of a validation project and what happens at each stage
4.
4. Discuss process validation requirements and the lifecycle approach
5.
5. Interpret the different requirements which are necessary for a User Requirement Specification and how this links to the success of a validation project
6.
6. Explain the validation categories
Teaching and Learning Strategies
Teaching will be online by means of an interactive weekly online lecture. Lectures will be recorded for those who cannot attend the live lecture.
Module Assessment Strategies
Assessment will consist of both continuous assessment undertaken during the semester and an end of semester final written exam.
Repeat Assessments
Students will be able to sit a repeat final examination in the event of a failed exam.
Students who do not submit C/A may be required to submit C/A before passing the module.
Indicative Syllabus
History of validation requirements: Explain the evolution of validation requirements. give examples of incidents which have resulted in strict requirements of today.
Types of validation: Explain types of validation deemed acceptable by regulatory authorities and when each is relevant.ICH Q8- QbD versus traditional approach.
Annex 15: Explain the concept of Annex 15 and the specific regulatory requirements for different types of validation
Stages of a validation project: URS, FDS, DQ, IQ, OQ and PQ What happens at each stage
Validation documentation: Validation Master Plan (and content), Validation protocols, Validation Summary Reports
Risk Assessment: FMEA and its relevance to validation projects
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 | Multiple choice moodle quiz | Coursework Assessment | Multiple Choice/Short Answer Test | 15 % | Week 8 | 1,2,3,4,5,6 |
| 2 | Essay type assignment | Coursework Assessment | Essay | 25 % | Week 4 | 1,2,3,4,5,6 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final written exam | Final Exam | Closed Book Exam | 60 % | End of Semester | 1,2,3,4,5,6 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Online | Online Lecture weekly | 1 | Weekly | 1.00 |
| Independent Learning | Not Specified | Required independent learning | 4 | Weekly | 4.00 |
Total Online Learning Average Weekly Learner Contact Time 1.00 Hours
Required & Recommended Book List
Recommended Reading
1998 Validation Fundamentals Interpharm/ CRC
1998 Validation Fundamentals Interpharm/ CRC
How to, What to, When to validate
Recommended Reading
2003-03-27 Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences) CRC Press
ISBN 8126541040 ISBN-13 9788126541041
2003-03-27 Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences) CRC Press
ISBN 8126541040 ISBN-13 9788126541041
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Recommended Reading
2007-09-25 Validation of Pharmaceutical Processes, 3rd Edition CRC Press
ISBN 0849370558 ISBN-13 9780849370557
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
2007-09-25 Validation of Pharmaceutical Processes, 3rd 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
Required Reading
2017-01-06 Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
ISBN 0857112856 ISBN-13 9780857112859
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.
Module Resources
Non ISBN Literary Resources
GMP Orange guide
What to, How to, When to validate Gibson, Powell-Evans
Journal Resources
N/A
Other Resources
N/A
Additional Information
N/A