GMP06001 2008 GMP 1 AND QUALITY ASSURANCE

General Details

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_SAPMS_H08 201600 Bachelor of Science (Honours) in Applied Medical Sciences 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 Continuous 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