Short Title:Validation
Full Title:Validation
Language of Instruction:English
Module Code:SYST H4040
Credits: 5
Field of Study:Pharmacy
Module Delivered in 1 programme(s)
Reviewed By:JOHN BEHAN
Module Author:MAEVE SCOTT
Module Description:This module aims to provide the student with knowledge of validation
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Define validation requirements
LO2 Research, interpret and apply regulatory requirements for validation studies
LO3 Generate validation plans, protocols and reports
LO4 Validate active, finished product and medical device manufacturing processes
LO5 Draft a cleaning validation study for pharmaceutical equipment
LO6 Devise regulatory requirements for the validation of automation systems
LO7 Devise and complete an analytical method validation study
LO8 Draft a technology transfer protocol
LO9 Describe cleaning validation requirements in pharmaceutical, biopharmaceutical and medical device industry

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment Assessment will include in class exam, assignment, presentation 1,2,3,4,5,6,7,8,9 30.00 Ongoing
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,3,4,5,6,7,8 70.00 End-of-Semester

TU Dublin – Tallaght Campus 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 lecture 3.00 Every Week 3.00
Independent Learning Independant learning 4.00 Every Week 4.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
This module has no Part Time workload.

Module Resources

Recommended Book Resources
  • International Society of Pharmaceutical Engineering, ISPE Baseline Pharmaceutical Engineering Guides, International Society of Pharmaceutical Engineering
  • United States Pharmacopial Convention, The United States Pharmacopia: the National Formulary
  • Directorate for the Quality of Medicines of the Council of Europe (EDQM), European Pharmacopoeia
  • ISPE, GAMP 5 Guide: Compliant GxP Computerised Systems
Recommended Article/Paper Resources
  • Institute of Validation Technology Various, Journal of Validation Technology
  • International Standards Organisation ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, ISO
  • Witcher, Mark F 2014, A working Definition of Quality by Design: Understanding its application to the development and Manufacturing of Biopharmaceuticals, BioProcessing Journal, Vol 13 Issue 1, 5 [ISSN: 1538-8786]
  • Stanley, Agnes 2015, Getting Scientific about Cleaning Validation, Pharmaceutical Technology, Vol 39 Issue 7
  • Committee for Medicinal Products for Human Use (CHMP) European Medicines Agency 2014, Guideline on setting health based exposure limits for use
  • Pharmaceutical Engineering 2007, ASTM, Commissioning and qualification: a New ASTM standard - GMP Regulations
  • ISPE 2013, Commissioning and Qualification (Verification) in the product process validation lifecycle, Pharmaceutical Engineering, 33
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
TA_SPHAR_B Bachelor of Science (Honours) in Pharmaceutical Science 7 Mandatory