GMP06001 2008 GMP 1 AND QUALITY ASSURANCE
Full Title
GMP 1 AND QUALITY ASSURANCE
Transcript Title
GMP 1 AND 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
Stage
Fee
€
Start Term
2008 - Full Academic Year 2008-09
End Term
2019 - Full Academic Year 2019-20
Author(s)
Fiona Donovan, Mary Butler
Programme Membership
SG_SGOOD_C06 200900 Higher Certificate in Science in Good Manuf Practice & Tech
SG_SGOOD_C06 201300 Higher Certificate in Science in Good Manuf Practive & Technol
SG_SAPMS_H08 201600 Bachelor of Science (Honours) in Applied Medical Sciences
SG_EPROC_S06 201500 Certificate in Process Technology
SG_EVALI_S06 201600 Level 6 Special Purpose Award in Validation Technologies
SG_EPROC_S06 201600 Certificate in Process Technology
SG_SGOOD_C06 201600 Higher Certificate in Science in Good Manuf Practive & Technol
SG_EPROC_S06 201700 Certificate in Process Technology
Description
Topics covered in this module include an orientation to GMP, documentation, conducting investigations, 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
.
Module Assessment Strategies
.
Repeat Assessments
.
Indicative Syllabus
Introduction to GMP
Quality Management
Personnel / Premises & Equipment
Documentation / Production
Quality Control / Contract Manufacture & analysis.
CAPA and means of preventing cross contamination.
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
Module Resources
Non ISBN Literary Resources
Rules and Guidance for Pharmaceutical manufacturers and distributors 2007 (Orange Guide).
"Development and Control of Medicines and Medical Devices"; RJ Harman, Pharmaceutical Press.
FDA, Code of Federal Regulations
Other Resources
None