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BIOT7004 - BioPharma Quality Management

Title:BioPharma Quality Management
Long Title:BioPharma Quality Management
Module Code:BIOT7004
Duration:1 Semester
Credits: 5
NFQ Level:Intermediate
Field of Study: Biotechnology
Valid From: Semester 1 - 2018/19 ( September 2018 )
Module Delivered in 2 programme(s)
Module Coordinator: Brigid Lucey
Module Author: Maire Begley
Module Description: This module covers various aspects of quality management including advanced quality systems, lab information management systems and standards in the pharmaceutical industry.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Explore the evolution of total quality management.
LO2 Explain the application and requirements of international standards and their role in designing, developing and maintaining a quality system in manufacturing and service industries.
LO3 Describe modern risk management strategies employed in pharmaceutical industries.
LO4 Recognise the practical applications of laboratory information systems in pharmaceutical industries.
LO5 Analyze and interpret quality-related data/case studies.
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
completion of module 3167
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.

No requirements listed

Module Content & Assessment

Indicative Content
Quality Management
Evolution of Total Quality Management. Management theories. Continuous quality improvement.
Total Quality Management Standards
National and international industry standards. ISO. GMP. GLP. GCP. Documentation.
Risk Management Systems
Risk Assessment. Risk Management. Hazard Analysis and Critical Control Point Analysis (HACCP). Failure Mode & Effect Analysis (FMEA).
Laboratory Information Management Systems (LIMS)
Use of LIMS in the Pharmaceutical industries. Hardware and Software requirements. Benefits.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Other End of term assessment - a combination of MCQ and short answer questions 1,2,3,4 60.0 Sem End
Written Report Written report on quality-related data/case studies. 5 40.0 Every Week
No End of Module Formal Examination
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The institute reserves the right to alter the nature and timings of assessment


Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based instruction 2.0 Every Week 2.00
Lecturer-Supervised Learning (Contact) Workshop/Lab 1.0 Every Week 1.00
Independent & Directed Learning (Non-contact) No Description 4.0 Every Week 4.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
This module has no Part Time workload.

Module Resources

Recommended Book Resources
  • Suresh Patel 2016, The Global Quality Management System: Improvement Through Systems Thinking, CRC Press [ISBN: 9781498739801]
Supplementary Book Resources
  • Tierney S., Morley M., Foley E. 2006, Modern Management, 3rd Ed., Gill and MacMillan [ISBN: 9780717140305]
  • James, L Vesper 2006, Risk assessment and risk management in the pharmaceutical industry : clear and simple, Davis Healthcare International Publishing [ISBN: 9781930114906]
  • Bhatt, V. 1998, GMP Compliance, Productivity and Quality, CRC Press [ISBN: 9781574910773]
Recommended Article/Paper Resources
  • ICH 2006, Guidance for Industry Q9 Quality Risk Management, June 2006
  • World Health Organization 2003, Application of Hazard Analysis and Critical Control, WHO Technical Report Series, No. 908
Supplementary Article/Paper Resources
  • Food and Drug Administration 2004, Innovation and Continuous Improvement in Pharmaceutical Manufacturing, FDA White Paper
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
CR_SPHBI_8 Bachelor of Science (Honours) in Pharmaceutical Biotechnology 6 Mandatory
CR_SBIBI_7 Bachelor of Science in Applied Biosciences and Biotechnology 6 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

Tel: 021-4326100     Fax: 021-4545343
Email: help@cit.edu.ie