BIO07030 2019 BioPharmaceutical Quality Systems

General Details

Full Title
BioPharmaceutical Quality Systems
Transcript Title
BioPharmaceutical Quality Syst
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
LIFE - Life Sciences
07 - NFQ Level 7
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Paul Walsh
Programme Membership
SG_SBIOP_J07 201900 Bachelor of Science in Science in Biopharmaceutical Science SG_SBIOE_E07 201900 Certificate in Science in Bioprocess Engineering L7 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

This module will demonstrate the importance of the systems approach both to quality and manufacturing

within the highly regulated biopharmaceutical sector.

Learning Outcomes

On completion of this module the learner will/should be able to;


Evaluate the development and importance of Quality System Standards.


Identify the principal requirements of a Quality System.


Evaluate the benefits of the ISO 9000:2005 and ISO17025:2005 Quality Systems


Illustrate the importance of documentation as required by a Quality System.


Discuss the importance of Good Manufacturing Practice in a regulated environment


Describe the main contents of a Quality Manual.

Teaching and Learning Strategies


Module Assessment Strategies

The assessment approach for this module will be 60% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ

Repeat Assessments

60% Continuous Assessment will include a range of assessment methods including some of the following: short-form assessment exams incl. MCQ

Indicative Syllabus

The development of the concept of quality and quality systems.

Assessment of the cost of quality, prevention costs, appraisal costs, failure costs.

Quality Management Systems : implementations and benefits, Regulatory bodies, Eudralex, ICH guidance docs

Quality System requirements ISO9000 :2005/ ISO 9001:2008, ICH Q 09 and Q10

Documentation and Documentation Change Control quality records.

Auditing, types of audit, non conformances and corrective action, the importance of self inspection.

Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP)/ ISO 17025

Principals of Validation, system, product, equipment etc.


Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 CA Continuous Assessment Assessment 30 % Week 4 1,2,3,4,5,6
2 Multiple Choice Questions Continuous Assessment Multiple Choice 20 % Week 10 1,2,3,4,5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final exam Final Exam Closed Book Exam 50 % End of Semester 1,2,3,4,5,6

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Online Online delivery 2 Weekly 2.00
Tutorial Online tutorial 1 Weekly 1.00
Total Online Learning Average Weekly Learner Contact Time 3.00 Hours

Module Resources

Non ISBN Literary Resources


Journal Resources


URL Resources

ISO guidelines, ICH guidelines

Other Resources


Additional Information