General Details

Full Title
Transcript Title
N/A %
Subject Area
GMP - Good Manufacturing Practice
LIFE - Life Sciences
06 - NFQ Level 6
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Aodhmar Cadogan, Eileen Armstrong
Programme Membership
SG_SGOOD_C06 201900 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 Science

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;


Describe the importance of calibration in industry today and explain how calibration is related to GMP


Describe some basic calibration procedures.


Describe the important elements of a calibration system.


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.



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


URL Resources

National Standards Authority of Ireland (2019) available: [accessed: 21 March 2019]

Irish National Accreditation Board (2019) available: [accessed: 21 March 2019] 

Health Products Regulatory Authority (HPRA)available: [accessed: 21 March 2019]

European Commisision (2019) EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, available: [accessed: 21 March 2019]

Other Resources

Provided by lecturer on a yearly basis

Additional Information