GMP06003 2019 Calibration science
Full Title
Calibration science
Transcript Title
Calibration science
Code
GMP06003
Attendance
N/A %
Subject Area
GMP - Good Manufacturing Practice
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Stage
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Aodhmar Cadogan, Eileen Armstrong
Programme Membership
SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice & Technology
SG_SINDU_B07 202300 Bachelor of Science in Industrial Laboratory Science
SG_SINDU_C06 202300 Higher Certificate in Science in Industrial Laboratory Science
SG_SINDU_E06 202300 Certificate in Laboratory Science
SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice and Technology
SG_SLTED_B07 202300 Bachelor of Science in Industrial Laboratory Science (Common Entry)
Description
The module introduces learners to the basic requirements of Calibration in Industry. The module links Calibration requirements in the Pharmaceutical industry to Good Manufacturing Practice and explains why Calibration is a basic GMP requirement.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe the importance of calibration in industry today and explain how calibration is related to GMP
2.
Describe some basic calibration procedures.
3.
Describe the important elements of a calibration system.
4.
Explain the role of Regulatory bodies in relation to Calibration.
Teaching and Learning Strategies
This module is delivered online via a variety of virtual learning platforms and software. The module will be taught using lectures supported by other electronic resources for use during independent self-directed learning and directed learning.
Module Assessment Strategies
Continuous Assessment and Final Examination
Repeat Assessments
As per ATU Sligo procedures
Indicative Syllabus
Calibration systems:
What calibration systems are and why they are necessary. How to determine the frequency of calibration of a laboratory instrument. What happens when an instrument fails calibration. What are accuracy, precision and traceability and how these relate to calibration. Introduction to the concept of Test Accuracy Ratio.
Regulatory requirements:
What are the regulatory requirements in relation to Calibration. Who the NSAI and INAB are and their role in relation to Calibration.
Standards:
The ISO standard that relates to Calibration requirements. What are Standards Laboratories. What is Accreditation and how laboratories gain accreditation.
GMP and Calibration Documentation:
How Calibration is related to GMP. What the role of various departments are in relation to Calibration. What the documentation requirements are for the Calibration system.
Instrument Calibration:
A basic introduction to calibration of commonly used laboratory instruments.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Continuous Assessment | Coursework Assessment | Assessment | 20 % | Week 5 | 1,2,3,4 |
| 2 | Continuous Assessment | Coursework Assessment | Assessment | 20 % | Week 10 | 1,2,3,4 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final Exam | Final Exam | Assessment | 60 % | End of Term | 1,2,3 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Not Specified | Lecture | 2 | Weekly | 2.00 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
Any book resources will be relayed by lecturer on yearly basis.
Journal Resources
None
URL Resources
National Standards Authority of Ireland (2019) available:https://www.nsai.ie/ [accessed: 21 March 2019]
Irish National Accreditation Board (2019) available: https://www.inab.ie/ [accessed: 21 March 2019]
Health Products Regulatory Authority (HPRA)available: https://www.hpra.ie/ [accessed: 21 March 2019]
European Commisision (2019) EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, available: https://ec.europa.eu/health/documents/eudralex/vol-4_en [accessed: 21 March 2019]
Other Resources
Provided by lecturer on a yearly basis
Additional Information
None