Module Details

Module Code: CHEP9007
Title: Analytical Technology Transfer
Long Title: Analytical Technology Transfer
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 presents the formal analytical process of transferring analytical methodologies, & their associated technology, in heavily regulated life science environments such as pharmaceutical & biopharmaceutical industries. This module targets analytical methods & technology in terms of lifecycle, transition from Research & Development to product launch at the manufacturing facility.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Determine the critical fundamentals of analytical test methods during a pharmaceutical & biopharmaceutical technology transfer.
LO2 Appraise in detail analytical test method transfer plan, protocol and report, including a detailed assessment of associated risk factors including environmental, health and safety factors, test method validation, quality and operational gap assessment that can influence analytical technology transfer decisions
LO3 Critique a broad range of pharmaceutical industry related analytical test methods.
LO4 Propose and evaluate analytical applications & requirements of quality, standardization & validation principles of analytical techniques in a regulated pharmaceutical environment.
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
Test Method Transfer Plan
Analytical method transfers team formation/training, transfer strategy, validation strategy, qualification of reference standards, critical reagents, method validation history, sample testing matrix. Analytical test method transfer guidance: EMA, USP, FDA & WHO.
Test Method Transfer Protocol
Analytical method transfer protocol, sample matrix types for TMT, same formulation/strengths and different sample types, reference standard or assay control, bias assessment, stability indicating methods, multiple strengths & bracketing, qualitative assays and negative controls, authentic/surrogate samples, retain samples. TMT gap assessment. Test method risk assessment & environmental health & safety.
Test Method Transfer Execution & Report
Comparative testing, co-validation, revalidation, transfer waiver and justification. Pre-approved protocol success criteria. Experimental designs and acceptance criteria for analytical testing, Equivalency, Intermediate Precision, Reproducibility concepts, compendial methods & verification. Equipment & qualified range for methods. Applications of modern immunochemical automated systems in biopharmaceutical.
Cleaning Verification TMT:
Clean in place (CIP), Clean out of Place (COP), dirty hold time, cleaning residual limits, visual inspection & criteria. Bioburden & endotoxins. Swab sampling, recovery of residues from surfaces, rinse sampling, swab recovery method assessment, swab recovery factors for different process material types, cleaning validation, solubility, therapeutic doses, toxicology category, recovery studies, chemical and micro agents.
Case Studies:
Swab recovery execution study, transfer protocol review e.g. assay test method
Analytical Measurement Technologies in Pharmaceutical:
Spectroscopic techniques, bioanalytical chromatography techniques, on-line versus off-line applications, process control and future trends. Process analytical technologies (PAT), challenges, chemometrics and data collection vibrations etc.
Analytical Test Method Lifecycle Management
USP1220, analytical procedure life cycle, quality target product profile (QTPP), analytical target profile (ATP), knowledge management, specification & decision rules, robustness & method operable design region (RMODR), analytical control strategy, control charts.
Module Content & Assessment
Assessment Breakdown%
Coursework50.00%
End of Module Formal Examination50.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 15
Timing Week 6 Learning Outcomes 1,2
Assessment Description
Test method transfer plan, strategy and regulatory guidance
Assessment Type Short Answer Questions % of Total Mark 15
Timing Week 8 Learning Outcomes 3,4
Assessment Description
Test method transfer protocol, report & types
Assessment Type Presentation % of Total Mark 20
Timing Week 10 Learning Outcomes 1,2,3
Assessment Description
Project/Case study presentation: Review analytical transfer case study and present to peers considering critical fundamentals of test methods and associated risk factors.
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 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 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. Every Week 3.00 3
Independent & Directed Learning (Non-contact) Non Contact Review of lecture notes and recommended material and preparation of reports for selected laboratory sessions and 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. Every Week 3.00 3
Independent & Directed Learning (Non-contact) Non Contact Review of lecture notes and recommended material and preparation of reports for selected laboratory sessions and 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
  • International Society for Pharmaceutical Engineering. (2018), ISPE Good Practice Guide: Technology Transfer, 3rd. [ISBN: 9781946964151].
Recommended Article/Paper Resources
  • Scypinski S., Young J.,. (2011), Analytical Methodology Transfer, Separation Science and Technology, 10, p.507.
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_ERNPI_9 Master of Science in Regulated New Product Introduction & Technology Transfer 2 Mandatory