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CHEM6008 - Quality & Validation

Title:Quality & Validation
Long Title:Quality and Validation
Module Code:CHEM6008
Credits: 5
NFQ Level:Fundamental
Field of Study: Chemistry
Valid From: Semester 1 - 2012/13 ( September 2012 )
Module Delivered in 9 programme(s)
Module Coordinator: Donagh OMahony
Module Author: MARY MC CARTHY
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:
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 considerations and constraints evident in the modern chemical and pharmaceutical industries
LO4 Develop basic quality documentation
Pre-requisite learning
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 CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
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

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
No Co Requisites listed

Module Content & Assessment

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. 100% inspection. Sampling inspection. 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.
Regulatory Requirements
Role of regulatory Bodies. Control of the conditions of manufacture and testing. Irish Medicines Board, US Food and Drug Administration, International Conference on Harmonisation etc.
Why document, regulatory requirements, different types of document and their roles. Elements of a documentation system.
Documented evidence, the meaning of validation. Validation policy, validation documentation, qualification. Process validation. Cleaning validation. Analytical method validation.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Practical/Skills Evaluation About 4-6 in-class and/or homework exercises submitted during the semester, to include teamwork and participation 1,2,3,4 40.0 Every Second Week
Project Short project or written report to be submitted and orally presented near end of semester 4 20.0 Week 11
Short Answer Questions Written assessment of course material held in last week of the course 1,2,3,4 40.0 Sem End
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 institute reserves the right to alter the nature and timings of assessment


Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Theory 2.0 Every Week 2.00
Lab Team exercises and group work 1.0 Every Week 1.00
Independent & Directed Learning (Non-contact) Personal study 4.0 Every Week 4.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
This module has no Part Time workload.

Module Resources

Recommended Book Resources
  • Michael J. Fox 1995, Quality Assurance Management, 2nd Ed. [ISBN: 0412636603]
  • Donna C. Summers, 2009, Quality, 5th Ed. [ISBN: 0131592491]
Supplementary Book Resources
  • Gregory B. Hutchins 1991, Introduction to Quality [ISBN: 0675208963]
  • Stanley Nusim 2009, Active Pharmaceutical Ingredients, 2nd Ed. [ISBN: 1439803366]
  • James L. Vesper 1997, Documentation Systems [ISBN: 1574910507]
This module does not have any article/paper resources
Other Resources
  • Website: US Food and Drug Administration (FDA)21 CFR 210/211, www.fda.gov
  • Website: International Conference on Harmonisation (ICH)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7 , www.ich.org

Module Delivered in

Programme Code Programme Semester Delivery
CR_SCHQA_8 Bachelor of Science (Honours) in Analytical Chemistry with Quality Assurance 3 Elective
CR_SCHQA_8 Bachelor of Science (Honours) in Analytical Chemistry with Quality Assurance 4 Elective
CR_SESST_8 Bachelor of Science (Honours) in Environmental Science and Sustainable Technology 4 Mandatory
CR_SINEN_8 Bachelor of Science (Honours) in Instrument Engineering 4 Mandatory
CR_SCHEM_7 Bachelor of Science in Analytical and Pharmaceutical Chemistry 3 Elective
CR_SCHEM_7 Bachelor of Science in Analytical and Pharmaceutical Chemistry 4 Elective
CR_SPHYS_7 Bachelor of Science in Applied Physics and Instrumentation 4 Mandatory
CR_SCHEM_6 Higher Certificate in Science in Chemistry 3 Elective
CR_SCHEM_6 Higher Certificate in Science in Chemistry 4 Elective

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