Module Details
| Module Code: |
CHEM8004 |
| Title: |
Pharmaceutical Quality
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Long Title:
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Pharmaceutical Quality
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| NFQ Level: |
Advanced |
| Valid From: |
Semester 1 - 2019/20 ( September 2019 ) |
| Field of Study: |
4421 - Chemistry
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| Module Description: |
This module gives the learner an in-depth understanding of quality management regulations, requirements and operations within the PharmaChem industry. This module builds on the Quality Modules that are taught in 2nd and 3rd year of this course.
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| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| # |
Learning Outcome Description |
| LO1 |
Design, complete and present a project based on the principles of Quality Management that are relevant to the regulated environment of the Pharma Chem sector. |
| LO2 |
Discuss the regulatory framework and requirements governing the production, testing and procurement of pharmaceutical products. |
| LO3 |
Interpret and communicate clearly and professionally on quality and regulatory matters in verbal and written form |
| LO4 |
Interpret and evaluate new developments in the field of quality |
| 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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Quality in the Analytical laboratory
Analytical method selection, optimisation and validation requirements, with reference to ICH Q2, Eurachem documents. Accreditation of laboratory analysis, ISO17025. Measurement uncertainty. Statistical Process Control (SPC) tools applied to evaluate laboratory data. The role of ethics in the Pharma Laboratory. Auditing the laboratory
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The role of the analyst in a Pharmaceutical GMP environment
Phases of drug development, analytical testing at each stage. Stability testing, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the European Medicines Agency regulatory and guidance documents. Laboratory controls and compliance. Method development, optimisation, validation and transfer. Dealing with Out of Specification (OOS) results.
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Managing for Quality
Total Employee Involvement. Teamwork, continuous improvement and systematic approach to problem solving: Use of quality tools and techniques. Leadership of teams, Organisational culture. Human Resources, six sigma and lean programmes.
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Relevant Regulatory Developments
For example: Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, Q8 Pharmaceutical development, Q9 Quality risk management, Q10 Quality Systems approach. FDA's 'Life Cycle' approach to validation.
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Guidelines on project completion
Preparation & planning, working with industry, completion of documentation, preparation of oral presentations.
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Module Content & Assessment
|
| Assessment Breakdown | % |
|---|
| Coursework | 100.00% |
Assessments
| No End of Module Formal Examination |
| Reassessment Requirement |
Coursework Only
This module is reassessed solely on the basis of re-submitted coursework. There is no repeat written examination.
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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 |
Pharmaceutical Quality |
Every Week |
3.00 |
3 |
| Lecturer-Supervised Learning (Contact) |
Contact |
Pharmaceutical Quality |
Every Week |
1.00 |
1 |
| Independent & Directed Learning (Non-contact) |
Non Contact |
Personal study |
Every Week |
3.00 |
3 |
| Total Hours |
7.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
4.00 |
| Workload: Part Time |
| Workload Type |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
| Lecture |
Contact |
Pharmaceutical Quality |
Every Week |
2.00 |
2 |
| Lecturer-Supervised Learning (Contact) |
Contact |
Pharmaceutical Quality |
Every Week |
2.00 |
2 |
| Independent & Directed Learning (Non-contact) |
Non Contact |
Personal Study |
Every Week |
3.00 |
3 |
| Total Hours |
7.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
4.00 |
|
Module Resources
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| Recommended Book Resources |
|---|
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Evans J. R., Lindsay W.M.. (2016), The management and control of quality, 9th. South-Western Congauge Learning, Ohio, U.S, [ISBN: 9781305662544].
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Dr Christine Oechslein. (2015), GMP Fundamentals, Maas and Peither, Washington, D.C., U.S., [ISBN: 9783958070066].
| | Supplementary Book Resources |
|---|
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Huber L.. (2007), Validation and Qualification in Analytical Laboratories, 2nd. Informa Healthcare Inc., N.Y., U.S., [ISBN: 9780849382673].
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Miller J.M. & Crowther J.B.. (2004), Analytical Chemistry in a GMP Environment, John Wiley & Sons, N.Y., U.S., [ISBN: 9780471314318].
| | This module does not have any article/paper resources |
|---|
| Other Resources |
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Website, US FDA. Various GMP Documents,
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Website, International Council on Harmonisation. Various documents related to
harmonisation of pharmaceutical
regulation e.g. Q2, Q7, Q8, Q9, Q10,
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Website, Eurachem. Guideline documents related to
analytical validation, measurement
traceability, measurement uncertainty
etc.,
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