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CHEA8003 - Analytical & Regulatory Stds.

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Title:Analytical & Regulatory Stds.
Long Title:Analytical & Regulatory Stds.
Module Code:CHEA8003
 
Duration:1 Semester
Credits: 5
NFQ Level:Advanced
Field of Study: Analytical Chemistry
Valid From: Semester 1 - 2019/20 ( September 2019 )
Module Delivered in 2 programme(s)
Next Review Date: February 2023
Module Coordinator: Donagh OMahony
Module Author: AMBROSE FUREY
Module Description: This module focuses on the applications of analytical chemistry and regulatory standards/requirements in the areas of food analysis, environmental analysis and pharmaceutical analysis.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Discuss the legal and regulatory requirements in relation to method validation and the testing of food and animal products
LO2 Evaluate the application of selected instrumental methods for the determination of food borne analytes/contaminants
LO3 Discuss the legal and regulatory requirements in relation to environmental limits, monitoring requirements and industrial hygiene
LO4 Evaluate the application of selected instrumental methods for the determination of environmental contaminants
LO5 Discuss the legal and regulatory requirements for new pharmaceuticals
LO6 Evaluate the application of selected instrumental methods for the determination of drugs and bioactive protein/peptides
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).
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
 

Module Content & Assessment

Indicative Content
Food Analysis
This section of the module links analytical chemistry with the laws and regulations pertinent to the food sector.
Regulations
Regulatory standards relevant to the analyst. For example, reference to 2002/657/EC (performance of analytical methods and the interpretation of results); COUNCIL DIRECTIVE 96/23/EC (measures to monitor certain substances and residues in live animals and animal products); Regulation (EC) No 1881/2006 setting maximum levels for dangerous contaminants in foodstuffs and Regulation (EC) No 401/2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs.
Sample Preparation and Instrumental Methods
Techniques for sample extraction and for the preparation of test samples. Instrumental techniques for the analysis of food, feed, food constituents, additives and food contaminants.
Environmental Chemistry
This section of the module links analytical chemistry with the laws and regulations pertinent to the environmental sector.
Regulations
Regulatory bodies, Regulatory standards relevant to the environmental area. For example, the Ambient Air Quality and Cleaner Air for Europe (CAFE) Directive (2008/50/EC) and Directive 2000/60/EC-Water Framework Directive) and licensing.
Industrial Hygiene
Health and Safety Law (Safety, Health and Welfare at Work Acts 2005 and 2010). Indoor monitoring of organics, inorganics and particulates.
Ambient Air, Water and Industrial Monitoring
Sampling strategies and analytical methods for regulated contaminants.
Pharmaceutical Analysis
This section of the module links analytical chemistry with the laws and regulations pertinent to the pharmaceutical sector.
Regulations
Regulatory standards relevant to the analyst. For example, reference to: Q2(R1) - Validation parameters for Analytical Methods; Q1A(R2) - Stability testing of new Drug Substances and Products; Q1B - Photostability testing of new Drug Substances and Products; Q6A - Test Procedures and Acceptance Criteria for new Drug Substances and New Drug Products.
Chromatographic and Spectroscopic Analysis of BioPharma products
Liquid chromatography (LC) and spectroscopic methods in the quantitative analysis of Biopharmaceuticals, Stability studies, Causes, evaluation, solutions and monitoring of Ion Suppression samples matrix effects. Bioequivalence and Bioavailability.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Presentation Written essay (1200 words) and formal presentation on an assigned Food topic 1,2 25.0 Week 4
Presentation Written essay (1200 words) and formal presentation on an assigned Environmental topic 3,4 25.0 Week 7
Presentation Written essay (1200 words) and formal presentation on an assigned Pharmaceutical topic 5,6 25.0 Week 10
Short Answer Questions One in-class written test on course material 1,3,5 25.0 Week 13
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.

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
Lab Computer focused lectures will focus on the applications of analytical chemistry and regulatory standards in the areas of food, environmental and pharmaceutical chemistry 3.0 Every Week 3.00
Lecturer-Supervised Learning (Contact) Presentation preparation, delivery and assessment 1.0 Every Week 1.00
Directed Learning Personal study 3.0 Every Week 3.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lab Computer focused lectures will focus on the applications of analytical chemistry and regulatory standards in the areas of food, environmental and pharmaceutical chemistry 3.0 Every Week 3.00
Lecturer-Supervised Learning (Contact) Presentation preparation, delivery and assessment 1.0 Every Week 1.00
Directed Learning Personal study 3.0 Every Week 3.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
 

Module Resources

Recommended Book Resources
  • Bryan M. Ham, Aihui MaHam 2015, Analytical Chemistry: A Chemist and Laboratory Technician's Toolkit, 1st Ed., 33, John Wiley & Sons, Inc. [ISBN: 9781118714843]
  • David G. Watson 2017, Pharmaceutical Analysis : A Textbook for Pharmacy Students and Pharmaceutical Chemists, 4th Ed., Elsevier Health Sciences London, United Kingdom [ISBN: 9780702069895]
  • John Wright 2004, Environmental Chemistry, Taylor & Francis Ltd London, United Kingdom [ISBN: 9780415226004]
Supplementary Book Resources
  • S. Suzanne Nielsen 2010, Food Analysis, Springer-Verlag New York Inc. New York, NY, United States [ISBN: 9781441914774]
  • S. Suzanne Nielsen 2017, Food Analysis Laboratory Manual, 3rd Ed., 35, Springer International Publishing AG Cham, Switzerland [ISBN: 9783319441252]
  • Kay, J.F., MacNeill, J.D., Wang, J. 2017, Chemical Analysis of Non-antimicrobial Veterinary Drug Resides in Food, 1-10, Wiley N.J., U.S. [ISBN: 9781118695074]
  • Wong, Yui-chung and Lewis, R.J. 2017, Analysis of Food Toxins and Toxicants, Wiley Blackwell Chichester, UK [ISBN: 9781118992722]
  • Meriluoto, J., Spoof, L. and Codd, G.A. 2017, Handbook of Cyanobacterial Monitoring and Cyanotoxin Analysis, Wiley Chichester, UK [ISBN: 9781119068686]
  • James N. Lowe 1993, Chemistry, Industry and the Environment, Wm. C. Brown Dubuque, Iowa [ISBN: 9780697170873]
  • Mark Holladay 2014, The Organic Chemistry of Drug Design and Drug Action, 3rd Ed., Academic Press [ISBN: 978-0126437324]
Recommended Article/Paper Resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_SCHQA_8 Bachelor of Science (Honours) in Analytical Chemistry with Quality Assurance 8 Mandatory
CR_SESST_8 Bachelor of Science (Honours) in Environmental Science and Sustainable Technology 8 Elective

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

Tel: 021-4326100     Fax: 021-4545343
Email: help@cit.edu.ie