Module Details
| Module Code: |
CHEM6008 |
| Title: |
Quality & Validation
|
|
Long Title:
|
Quality and Validation
|
| NFQ Level: |
Fundamental |
| Valid From: |
Semester 1 - 2019/20 ( September 2019 ) |
| Field of Study: |
4421 - Chemistry
|
| Module Description: |
This is an introductory course aimed at those studying laboratory-based science courses, which seeks to give learners an overview of the role of quality within industry.
|
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| # |
Learning Outcome Description |
| LO1 |
Explain terms and concepts relevant to quality |
| LO2 |
Describe the interrelationships among product design, materials, personnel, manufacturing processes, final output, and the inspection/testing/analysis function within manufacturing industry. |
| LO3 |
Outline regulatory requirements in modern chemical and pharmaceutical industries |
| LO4 |
Introduction to quality documentation |
| 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 |
|
Introduction to Quality
The meaning of quality. Measuring quality. Inspection, quality control and quality assurance. The customer's specification. Quality in design, planning, purchasing,
production, service.
|
|
The role of quality control
Specifications and inspection procedures. Attributes and variables. Inspection & test. Raw materials inspection. Sampling theory. The role of the testing laboratory. Acceptance testing.
|
|
Human aspects of Quality
The role of the human in the achievement of quality. A people based philosophy. Motivation, involvement, problem solving in teams. Introduction to problem solving tools. Empowerment. Introduction to workplace ethics.
|
|
Regulatory Requirements
Role of regulatory bodies. Control of the conditions of manufacture and testing. Health Products Regulatory Authority, US Food and Drug Administration, Eurpoean Medicines Agency, International Conference on Harmonisation, ISO, NIST, etc.
|
|
Documentation
Why document? regulatory requirements, different types of documents and their roles. Elements of a documentation system.
|
|
Validation
Documented evidence, the meaning of validation. Validation documentation. Qualification. Process validation. Cleaning validation. Analytical method validation.
|
|
Module Content & Assessment
|
| Assessment Breakdown | % |
|---|
| Coursework | 100.00% |
Assessments
| 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 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 |
Every Week |
2.00 |
2 |
| Lab |
Contact |
Team exercises and group work |
Every Week |
1.00 |
1 |
| Independent & Directed Learning (Non-contact) |
Non Contact |
Personal study |
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 |
Every Week |
2.00 |
2 |
| Lab |
Contact |
Team exercises and group work |
Every Week |
1.00 |
1 |
| Independent & Directed Learning (Non-contact) |
Non Contact |
Personal study |
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 |
|---|
-
Michael J. Fox. (2014), Quality Assurance Management, 3rd. Springer, U.K., [ISBN: 9781489971418].
-
Donna C. Summers,. (2009), Quality, 6th. Pearson, U.K., [ISBN: 978013441327].
| | Supplementary Book Resources |
|---|
-
Gregory B. Hutchins. (1991), Introduction to Quality, [ISBN: 0675208963].
-
Stanley Nusim. (2009), Active Pharmaceutical Ingredients, 2nd. Taylor Francis, U.s., [ISBN: 9781439803363].
-
Anna Gravells. (2016), Principles and Practices of Quality Assurance, SAGE, U.K., [ISBN: 9781473973428].
| | This module does not have any article/paper resources |
|---|
| Other Resources |
|---|
-
Website, US Food and Drug Administration (FDA). 21 CFR 210/211,
-
Website, International Conference on
Harmonisation (ICH). Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients Q7,
|
|
