BIO07030 2013 BioPharmaceutical Quality Systems

General Details

Full Title
BioPharmaceutical Quality Systems
Transcript Title
BioPharma Q Systems
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
LIFE - Life Sciences
07 - NFQ Level 7
05 - 05 Credits
Start Term
2013 - Full Academic Year 2013-14
End Term
9999 - The End of Time
Fiona Donovan, Mary Butler

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.

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
60 %
End of Semester / Year Formal Exam
40 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 CA Continuous Assessment Assessment 60 % 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 Closed Book Exam 40 % 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

URL Resources

ISO guidelines, ICH guidelines