Short Title:Good Manufacturing Practice and Quality Systems
Full Title:Good Manufacturing Practice and Quality Systems
Language of Instruction:English
Module Code:GMPR H3040
 
Credits: 5
Field of Study:Pharmacy
Module Delivered in 7 programme(s)
Reviewed By:JOHN BEHAN
Module Author:MAEVE SCOTT
Module Description:This module aims to provide the student with the knowledge and practical skills of good manufacturing practice in the pharmaceutical regulated industries.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Outline the function of GMP regulatory control bodies within industry.
LO2 Apply GMP to an industrial environment.
LO3 Write a Standard Operating Procedure.
LO4 Explain validation documentation
LO5 Apply quality systems to an industrial environment
LO6 Explain the benefits of operational excellence, six sigma, lean manufacturing
LO7 Describe marketing application routes in Europe and US for new medicinal products
LO8 Describe marketing authorisation routes in Europe and US for new medicinal products
LO9 Describe marketing application routes in Europe and US for new medicinal products
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment in class assignments, individual and group assignments 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 1,2,3,4,5,6,7,8,9 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 Class based learning 3.00 Every Week 3.00
Independent Learning independent learning 3.00 Every Week 3.00
Total Weekly Learner Workload 6.00
Total Weekly Contact Hours 3.00
This module has no Part Time workload.
 

Module Resources

Recommended Book Resources
  • The Directorate for the Quality of Medicines of the Council of Europe (EDQM)], European Pharmacopoeia
  • USP, United States Pharmacopeia: National Formulary
Required Article/Paper Resources
  • Herb Lutz 2005, Introduction to Validation of Biopharmaceuticals, BioPharm International, Issue 1
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SABIO_B Bachelor of Science (Honours) in Bioanalytical Science 5 Mandatory
TA_SPHAR_B Bachelor of Science (Honours) in Pharmaceutical Science 5 Mandatory
TA_SADNF_B Bachelor of Science Hons in DNA and Forensic Analysis 5 Mandatory
TA_SBIOL_D Bachelor of Science in Bio Analysis (1 year add-on Bachelor Degree) 5 Mandatory
TA_SASCI_D Bachelor of Science in Bioanalysis or Chemical Analysis 5 Group Elective 1
TA_SADNF_D Bachelor of Science in DNA and Forensic Analysis 5 Mandatory
TA_SAPHR_D Bachelor of Science in Pharmaceutical Science 5 Mandatory