Module Details

Module Code: CHEP9006
Title: Operations Transfer Ready
Long Title: Operations Transfer Readiness
NFQ Level: Expert
Valid From: Semester 1 - 2024/25 ( September 2024 )
Duration: 1 Semester
Credits: 5
Field of Study: 5240 - Chemical & Process Eng
Module Delivered in: 1 programme(s)
Module Description: This module provides a concise insight into pharmaceutical & biopharmaceutical manufacturing operations while considering regulatory, bioprocess operations, cGMP layout approach, and manufacturing operations strategies.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Characterize key pharmaceutical & biopharmaceutical manufacturing operations.
LO2 Appraise critical attributes of containment, contamination and closing operations for pharmaceutical and/or biopharmaceutical manufacturing processes.
LO3 Critique a broad range of biopharmaceutical and/or pharmaceutical manufacturing operations in relation to operations management.
LO4 Critique the key aspects of biopharmaceutical and/or pharmaceutical manufacturing layouts from cGMP and sustainability perspectives.
Dependencies
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
Requirements

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
 
Indicative Content
Pharmaceutical Manufacturing Operations.
Small & large molecule, secondary (i.e. solid dosage), blending, compression, filtration, heating, encapsulation, shearing, tableting, granulation, coating and drying.
Biopharmaceutical Manufacturing
Bioprocessing, plant & process contamination control, disposable technologies. Cell culture start up/scale up upstream processing, bioreactor control, design & operation. harvest, centrifugation, filtration, harvest technologies, micro filtration downstream processing, bulk filling, chromatography, filtration UF/DF, viral clearance. formulation, fill finish & lyophilisation, single use. critical quality attributes & critical process parameters, aseptic & axenic operations, bioburden in aseptic/axenic operations,
Active Pharmaceutical Ingredients Operations & Considerations:
Process safety considerations, environmental impact. economics - unit cost to manufacturer. scalability considerations. atex, green chemistry.
Manufacturing Operations Strategy & Management:
Process/facility fit assessment & process fit to plant (PF2P), Production Technology: process design & selection, equipment, facility considerations, containment, ergonomics. Manufacturing site establishment: talent pool, utility availability, business environment, local government support, supply chains and logistics planning, operations costs, facility expandability, taxation frame, contingency, disaster and recovery considerations, asset disposal, brownfield and greenfield facilities. Single site multipurpose flexibility, capacity definition and utilization, changeover considerations, regulatory constraints, clinical versus commercial manufacturing, manufacturing scale. Inventory management in pharmaceutical manufacturing, key performance indicators, visual management, org structures, quality and HSE compliance, logistics, planning and materials management.
Manufacturing cGMP Layout Approaches:
Regulatory filing & common technical documents (CTD's). Production capacity, process, scale & technologies. Product protection. Segregation strategies: batches, products, virus reduced operations, cell (+) from cell (-) operations, open and closed operations, vaccines & biological hazard containment.
Advanced Therapies Manufacturing
Cell & gene therapies, cellular immunotherapy, stem cell therapy, vaccine manufacture
Module Content & Assessment
Assessment Breakdown%
Coursework50.00%
End of Module Formal Examination50.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 25
Timing Week 8 Learning Outcomes 1,2
Assessment Description
In-class test based on lecture material: Key pharmaceutical & biopharmaceutical manufacturing operations. Critical attributes of biopharmaceutical manufacturing as per lecture material
Assessment Type Presentation % of Total Mark 25
Timing Week 11 Learning Outcomes 3,4
Assessment Description
Biopharmaceutical/Pharmaceutical presentation: Operations management and cGMP layout approaches. Impact of implementing sustainability enhancement features.
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 50
Timing End-of-Semester Learning Outcomes 1,2,3,4
Assessment Description
End-Of-Semester Formal Exam
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 University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Theory on course topics and discussion of industry relevant examples. Any guest lectures will be arranged based on industry expert's availability and at the beginning of each semester where possible. Assigned module lecturers will advise accordingly regarding guest lecturers & schedule. Every Week 3.00 3
Independent & Directed Learning (Non-contact) Non Contact Review of lecture notes and recommended material in-class topics. Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Theory on course topics and discussion of industry relevant examples. Any guest lectures will be arranged based on industry expert's availability and at the beginning of each semester where possible. Assigned module lecturers will advise accordingly regarding guest lecturers & schedule. Every Week 3.00 3
Independent & Directed Learning (Non-contact) Non Contact Review of lecture notes and recommended material in-class topics. Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • Medicines and Healthcare Products Regulatory Agency. (2022), Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide), [ISBN: 9780857114396].
  • Larry E. Fast,. (2015), The 12 Principles of Manufacturing Excellence. A Lean Leaders Guide to Achieving and Sustaining Excellence, 2nd. Taylor & Francis, [ISBN: 9781498730914].
Recommended Article/Paper Resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_ERNPI_9 Master of Science in Regulated New Product Introduction & Technology Transfer 1 Mandatory