| Title: | Validation of Quality Systems |
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| Long Title: | Validation of Quality Systems |
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| Field of Study: |
Chemistry
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| Valid From: |
Semester 1 - 2020/21 ( September 2020 ) |
| Module Coordinator: |
Donagh OMahony |
| Module Author: |
Grainne Conneely |
| Module Description: |
In this module students will learn about the validation of systems in a GMP environment. Students will become proficient in Computer Systems Validation within a Quality Management System in context of highly regulated industries, such as pharmaceutical manufacturing and medical device industries. |
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| LO1 |
Understand the fundamentals of a validation process |
| LO2 |
Demonstrate an understanding of the principles of Computer Systems Validation |
| LO3 |
Exercise appropriate judgement and a mastery of skills in applying a Risk Based approach for validation |
| LO4 |
Demonstrate the ability to critically review and analyse the regulatory requirements of validation |
| LO5 |
Demonstrate the ability to use advanced skills to evaluate and plan a computer systems validation exercise with relevant documentation requirements |
| Pre-requisite learning |
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
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Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list. |
| No incompatible modules listed |
Co-requisite Modules
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| No Co-requisite modules listed |
Requirements
This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
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| No requirements listed |
Module Content & Assessment
| Indicative Content |
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Overview of Validation
Basic principles and requirements of validation including Process (Batch, Continuous Manufacturing and Continuous Process Verification), Cleaning, Utilities, Analytical Method and Computer Systems Validation. Regulatory guidance on validation.
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Systems and Environments
An overview of the types of systems for Validation (Test/Non-Production, QC systems, Manufacturing, IT), Validation Environments (Development, Quality Assurance, Production, Non-Production). Activities performed in each environment.
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Regulatory Requirements
Review of the regulatory requirements, requirements of 21CFR part 11 and Annex 11, background and purpose of part 11, audit trail requirements, security & access levels, Electronic records/Electronic Signatures (ERES), passwords, unique IDs, auto logout. Spreadsheet Validation. Highlight differences and similarities of 21CFR11 and Annex 11. Review of Warning Letters.
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Validation overview for Computer Systems Validation
Risk-based approach, V-model for CSV (GAMP), GAMP as applied to Computer Systems, GAMP Principles. Backup and restoration, disaster recovery, Change Control, Business Continuity, Source code review, computer systems support and maintenance, computer systems delivery, risk evaluation, periodic review, physical and logical security.
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Data Integrity
ALCOA+ Principles, segregation of duties, practical approach to audit trail review, data lifecycle diagrams, data Integrity assessments, falsification of data, requirements of QC Systems / Manufacturing Systems / IT Systems, additional controls for weak audit trails.
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| Assessment Breakdown | % |
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| Course Work | 100.00% |
| Course Work |
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| Assessment Type |
Assessment Description |
Outcome addressed |
% of total |
Assessment Date |
| Practical/Skills Evaluation |
Multiple Choice Questions / Short Answer Questions |
1,2,4 |
30.0 |
Week 6 |
| Other |
Produce a report (approx 3000 words) and a presentation on an assigned case study. |
3,5 |
40.0 |
Week 10 |
| Project |
Project assignment on the role of CSV in record intergrity. |
1,3,4,5 |
30.0 |
Sem End |
| No End of Module Formal Examination |
| Reassessment Requirement |
Coursework Only
This module is reassessed solely on the basis of re-submitted coursework. There is no repeat written examination.
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The institute reserves the right to alter the nature and timings of assessment
Module Workload
| Workload: Full Time |
| Workload Type |
Workload Description |
Hours |
Frequency |
Average Weekly Learner Workload |
| Lecture |
Theory |
1.0 |
Every Week |
1.00 |
| Tutorial |
Application of theory and principles, teamwork problem solving |
1.0 |
Every Week |
1.00 |
| Independent & Directed Learning (Non-contact) |
Lecturer and Self-directed Study |
5.0 |
Every Week |
5.00 |
| Total Hours |
7.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
2.00 |
| Workload: Part Time |
| Workload Type |
Workload Description |
Hours |
Frequency |
Average Weekly Learner Workload |
| Lecture |
Theory |
1.0 |
Every Week |
1.00 |
| Tutorial |
Application of Theory and principles, teamwork problem solving |
1.0 |
Every Week |
1.00 |
| Independent & Directed Learning (Non-contact) |
Lecturer and Self Directed Study |
5.0 |
Every Week |
5.00 |
| Total Hours |
7.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
2.00 |
Module Resources
| Recommended Book Resources |
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- Orlando Lopez 2018, Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation [ISBN: 9781138041189]
- John R. Sharp 2005, Good pharmaceutical manufacturing practice: rationale and compliance [ISBN: 0849319943]
| | Supplementary Book Resources |
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- ISPE 2008, The GAMP Guide for Validation of Automated Systems [ISBN: 1931879613]
- Anurag S Rathore, Gail K. Sofer 2012, Process validation in manufacturing of biopharmaceuticals [ISBN: 9781439850930]
- Syed Imtiaz Haider, Erfan Syed Asif 2018, Quality control training manual; comprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories [ISBN: 1138077526]
| | This module does not have any article/paper resources |
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| Other Resources |
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- Website: Food and Drug Administration
- Website: Health Products Regulatory Authority
- Website: EU GMP Guidelines
- Website: International Medical Device Regulators
Forum
- Website: International Council for Harmonisation
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Module Delivered in
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