GMP06001 2019 GMP 1 QUALITY ASSURANCE

General Details

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 Special Purpose Award in Engineering in Validation Technologies SG_SGOOD_C06 201900 Higher Certificate in Science in Good Manufacturing Practice & Technology SG_SBIOM_H08 202000 Bachelor of Science (Honours) in Science in Biomedical and BioIndustrial Sciences SG_SAPMS_H08 202000 Bachelor of Science (Honours) in Science in Applied Medical Sciences
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 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

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

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

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
Other Resources

None

Additional Information

None