PHRM07022 2020 Pharmaceutical Quality Systems
Full Title
Pharmaceutical Quality Systems
Transcript Title
Pharmaceutical Quality Systems
Code
PHRM07022
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
07 - Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Colin Fowley
Programme Membership
SG_SPHAD_B07 201900 Bachelor of Science in Pharmaceutical Science
SG_SAPIS_J07 202300 Bachelor of Science in Applied Industrial Science
Description
This module will demonstrate the importance of the systems approach both to quality and manufacturing within the highly regulated pharmaceutical sector. Systems such as ISO 9000:2015, ISO17025 and the ICH guideline on pharmaceutical quality systems will be examined and topics such as document and product traceability will be analysed.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Evaluate the development and importance of Quality System Standards.
2.
Identify the principal requirements of a Quality System.
3.
Evaluate the benefits of the ISO 9000, ISO17025 and the ICH Q10 Quality System guideline.
4.
Illustrate the importance of documentation as required by a Quality System.
5.
Discuss the importance of Good Manufacturing Practice in a regulated environment.
Teaching and Learning Strategies
This module will be delivered online. This will include live and prerecorded lectures augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment.
Module Assessment Strategies
This module is 100% Continuos Assessment
Repeat Assessments
Repeat Continuos Assessment
Indicative Syllabus
1.Evaluate the development and importance of Quality System Standards.
The development of the concept of quality and quality systems.
Assessment of the cost of quality, prevention costs, appraisal costs, failure costs.
2. Identify the principal requirements of a Quality System.
Quality Management Systems : implementations and benefits.
Quality System requirements - ISO9000 and ISO 17025.
3. Evaluate the benefits of the ISO 9000 and ISO17025 Quality Systems.
Quality Management Systems : implementations and benefits.
4.Illustrate the importance of documentation as required by a Quality System.
Documentation and Documentation Change Control - quality records.
The Quality Manual - Contents and structure.
5.Discuss the importance of Good Manufacturing Practice in a regulated environment.
Auditing, types of audit, non-conformances and corrective action, the importance of self inspection.
Principals of Validation, system, product, equipment etc.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | CA 1 MCQ | Coursework Assessment | Multiple Choice/Short Answer Test | 20 % | Start of Semester | 1,2 |
| 2 | MCQ & SAQ | Coursework Assessment | Multiple Choice/Short Answer Test | 20 % | Week 9 | 1,2,3 |
| 3 | Technical Report | Coursework Assessment | Project | 40 % | Week 11 | 4,5 |
| 4 | Focus on Standardization | Coursework Assessment | Written Report/Essay | 20 % | Week 12 | 3,4,5 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Online Lecture | Online | Lecture | 2 | Weekly | 2.00 |
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
ISO9001
ISO17025
ISO07045
ICH Q10
Journal Resources
URL Resources
Other Resources
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7
Additional Information
N/A