VALD06002 2016 Validation applications
Full Title
Validation applications
Transcript Title
Validation applications
Code
VALD06002
Attendance
N/A %
Subject Area
VALD - Validation
Department
MENG - Mech. and Electronic Eng.
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2016 - Full Academic Year 2016-17
End Term
2019 - Full Academic Year 2019-20
Author(s)
Mary Nolan, Fiona Donovan
Programme Membership
SG_EVALI_S06 201600 Level 6 Special Purpose Award in Validation Technologies
Description
This module builds on the knowledge gained in validation principles. This module explains how validation activities are undertaken from a practical point of view. It covers Cleanroom and Cleaning validation, analytical method validation and includes an introduction to computer systems validation and sterilisation validation.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
1. Define how validation principles are applied to actual validation projects
2.
2. Actively participate in completing different validation projects in pharma/ biopharma and medical device companies such as cleanroom validation, cleaning validation, computer systems validation and sterilisation validation projects
3.
3. Understand the sequence of events necessary for a successful validation project
4.
4. Evaluate the importance of cleaning to the organisation and discuss how a cleaning validation project can be undertaken.
5.
5. Understand the importance of analytical method validation and what factors must be considered when validating an analytical method.
Teaching and Learning Strategies
There will be a 1 hour live lecture weekly. Lectures will be recorded for those who cannot attend live lectures. Relevant information such as journal articles, websites or other material may be made available to support lecture content.
Module Assessment Strategies
Assessment will take place throughout the semester in the form of online quizzes or essay assignments.
There will be an end of semester final written exam.
Repeat Assessments
Students will need to liaise directly with the lecturer to determine repeat assessment outcomes based on their performance throughout the module.
Indicative Syllabus
1. Cleanroom Classification: ISO 14644 standard classification and EU classification system. Overview of different types of cleanroom and the typical sequence of events when undertaking the validation of a cleanroom.
2, Cleaning programmes in the pharmaceutical/ biopharmaceutical and medical device sectors. Validating the cleaning process
3. Analytical Test methods- What are these? Importance of accuracy, precision, repeatbility, specificity, limit of detection, contents of validation report for a method validation
4. Differentiate between aseptic manufacture and terminal sterilisation- when is each relevant? Cover key sterilisation methods- moist heat, dry heat, ETO, gamma irradiation and filtration
5. Discuss commonly used computerised systems. Introduce annex 11 (eudralex vol 4) and importance of CSV. What are the key considerations in CSV?
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 | Online moodle quiz | Coursework Assessment | Multiple Choice/Short Answer Test | 10 % | Week 5 | 1,2,3,4,5 |
| 2 | Online moodle quiz | Coursework Assessment | Multiple Choice/Short Answer Test | 10 % | Week 8 | 1,2,3,4,5 |
| 3 | Essay C/A | Coursework Assessment | Essay | 20 % | Week 5 | 1,2,3,4,5 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Written Exam | Final Exam | Closed Book Exam | 60 % | End of Semester | 1,2,3,4,5 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Online Lecture | Online | Online Lecture | 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
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
1998 Validation Fundamentals Interpharm/ CRC
1998 Validation Fundamentals Interpharm/ CRC
What to, How to, When to validate
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
Module Resources
URL Resources
Eudralex Online http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
FDA website http://www.fda.gov/
HPRA website http://www.hpra.ie/
EMA website http://www.ema.europa.eu/ema/