GMP06001 2019 GMP 1 Quality Assurance
Full Title
GMP 1 Quality Assurance
Transcript Title
GMP 1 Quality Assurance
Code
GMP06001
Attendance
N/A %
Subject Area
GMP - Good Manufacturing Practice
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
10 - 10 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Fiona Donovan
Programme Membership
SG_EVALI_S06 201900 Level 6 Certificate in Validation Technologies
SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice & Technology
SG_SBIOM_H08 201800 Bachelor of Science (Honours) in Science in Biomedical and BioIndustrial Sciences
SG_SBIOM_H08 202000 Bachelor of Science (Honours) in Biomedical and BioIndustrial Sciences
SG_SAPMS_H08 202000 Bachelor of Science (Honours) in Applied Medical Sciences
SG_EVALP_E06 202300 Certificate in Validation Technologies with Project
SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice and Technology
Description
Topics covered in this module include an orientation to GMP, EU and US regulations, documentation requirements, conducting investigations, CAPA, auditing, QC (quality control) laboratory operations and management responsibilities. Upon completion, students will be able to apply these GMP practices in regulated industries.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Demonstrate a basic grounding in the fundamentals 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 standard.
2.
Describe the roles of QA and QC within a Quality Management system and their location within the process flow. Communicate examples of QA/QC responsibilities relevant to various processes.
3.
Describe the roles of all personnel, training, engineering, maintenance, production and contractors within a GMP organisation.
4.
Explain and illustrate the concepts of proper documentation utilized in a GMP environment and its function in traceability investigations and formal contracts.
5.
Participate in the use of the tools and methodologies that provide an approach for developing corrective and preventive actions that address and limit manufacturing failures.
6.
Describe key principles that ensure the validity of all data generated within a GMP environment.
Teaching and Learning Strategies
Lectures are delivered online and recorded and are supported by PDF lecture notes.
Module Assessment Strategies
.
Repeat Assessments
.
Indicative Syllabus
Introduction to GMP/ History of GMP
Eudralex/ FDA CFR'S/ ICH/ Quality Management
Personnel / Premises & Equipment/ Sterile Products
Documentation
Quality Assurance and Quality Control
CAPA and means of preventing cross contamination.
Auditing
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 | Assignments | Coursework Assessment | UNKNOWN | 40 % | OnGoing | 1,2,3,4,5,6 |
| 2 | Debate/discussion forums | Formative | UNKNOWN | - % | OnGoing | 1,2,3,4,5,6 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final Exam | Final Exam | Assessment | 60 % | End of Term | 1,2,3,4,5,6 |
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
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.
Required Reading
2001-11-09 The Jungle Courier Corporation
ISBN 9780486419237 ISBN-13 0486419231
2001-11-09 The Jungle Courier Corporation
ISBN 9780486419237 ISBN-13 0486419231
The author's famous tale of a Lithuanian family who emigrates to America and is destroyed by exploitation, crushing poverty, and economic despair.
Module Resources
Non ISBN Literary Resources
GMP Orange Guide
The Jungle: Upton Sinclair
Journal Resources
N/A
URL Resources
ICH Website: https://www.ich.org/
Eudralex Volume 4: https://ec.europa.eu/health/documents/eudralex/vol-4_en
FDA Website: https://www.fda.gov/
Other Resources
None
Additional Information
None