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BIOT8002 - Pharma Regulation & Compliance

Title:Pharma Regulation & Compliance
Long Title:Pharma Regulation & Compliance
Module Code:BIOT8002
Duration:1 Semester
Credits: 5
NFQ Level:Advanced
Field of Study: Biotechnology
Valid From: Semester 2 - 2021/22 ( January 2022 )
Module Delivered in 1 programme(s)
Module Coordinator: Brigid Lucey
Module Author: Suzanne Floyd
Module Description: This module develops the student's understanding of modern quality standards and also the application of quality improvement programs in the biopharmaceutical, medical device and healthcare sectors.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the essential elements of current international quality standards and their relevance in biopharmaceutical, medical device & herbal medicine industries
LO2 Explain the general applications and requirements of cGMP regulations in pharmaceutical & herbal medicine manufacturing
LO3 Outline the elements of process validation, method validation & Continuous Process Verification as key requirements in cGMP regulations
LO4 Describe the principles and applications of lean-six sigma, statistical process control and other current quality improvement initiatives and their applications
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 MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).

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 Systems
Documentation, GDP, BMR, CAPA
cGMP Regulations
cGMP 21CFR compliance requirements, FDA & EU regulations for pharmaceutical & herbal medicine manufacture, Process Analytical Technology
Quality Improvement Techniques
Six sigma training & implementation, Lean manufacturing (6S, Kaizen), Advanced concepts of Statistical Process control (SPC), Process Capability
Process & method validation, continuous process verification (CPV)
Total Quality Management Standards
ISO9000 series of standards, accreditation & compliance
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Presentation Analysis and evaluation of quality standards and cGMP regulations 1,2 40.0 Week 7
Other Case study analysis of quality and regulatory issues using short answer and multiple choice questions. 1,2,3,4 60.0 Week 13
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 Lecture 3.0 Every Week 3.00
Independent & Directed Learning (Non-contact) Independent & directed learning 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
  • Council for Six Sigma Certification, Setter, Craig Joseph 2018, Six Sigma: A Complete Step-by-Step Guide: A Complete Training & Reference Guide for White Belts, Yellow Belts, Green Belts, and Black Belts, 4th Ed.
  • Priscilla Browne 2017, Commissioning, Qualification and Validation: A GMP Approach
  • Douglas C. Montgomery 2019, Introduction to statistical quality control
This module does not have any article/paper resources
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
CR_SPHBI_8 Bachelor of Science (Honours) in Pharmaceutical Biotechnology 8 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

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