Module Details
| Module Code: |
CHEP9007 |
| Title: |
Analytical Technology Transfer
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Long Title:
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Analytical Technology Transfer
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| NFQ Level: |
Expert |
| Valid From: |
Semester 1 - 2024/25 ( September 2024 ) |
| Field of Study: |
5240 - Chemical & Process Eng
|
| 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.
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| 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).
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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.
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| No incompatible modules listed |
Co-requisite Modules
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| 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.
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| No requirements listed |
| Indicative Content |
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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.
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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.
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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.
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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.
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Case Studies:
Swab recovery execution study, transfer protocol review e.g. assay test method
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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.
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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.
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Module Content & Assessment
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| Assessment Breakdown | % |
|---|
| Coursework | 50.00% |
| End of Module Formal Examination | 50.00% |
Assessments
| End of Module Formal Examination |
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| 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.
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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 |
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Module Resources
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| Recommended Book Resources |
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International Society for Pharmaceutical Engineering. (2018), ISPE Good Practice Guide: Technology Transfer, 3rd. [ISBN: 9781946964151].
| | Recommended Article/Paper Resources |
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Scypinski S., Young J.,. (2011), Analytical Methodology Transfer, Separation Science and Technology, 10, p.507.
| | Other Resources |
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Ebook, Burgess, Chris. (2007), Valid Analytical Methods and Procedures
: A Best Practice Approach to Method
Selection, Royal Society of Chemistry,
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Technical Report, World Health Organisation. (2011), WHO guidelines on transfer of technology
in pharmaceutical manufacturing, Annex 7
in Series 961..
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Pharmacopeia, USP. (2014), Transfer of Analytical Procedures, General Chapter <1224>.
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Website, (2014), EU GMP Chapter 6 Quality Control,
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Pharmacopeia, USP. (2022), The Analytical Procedure Lifecycle,
General Chapter <1220>.
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Website, Internal Council for Harmonisation. (2022), ICH Q2 Analytical Validation,
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Website, Internal Council for Harmonisation. (2022), ICH Q14 Analytical Procedure Development,
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