Short Title:cGMP 3
Full Title:cGMP 3 (Regulatory Affairs and Validation)
Module Code:GMPR H3041
 
Credits: 5
Field of Study:Pharmacy
Module Delivered in 2 programme(s)
Reviewed By:JOHN BEHAN
Module Author:MIRIAM O DONOGHUE
Module Description:This module aims to provide the student with a detailed understanding of the requirements of the GMPs, MA’s, MA compliance and clinical trails.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Analyse and interpret the GMP guidelines and the legislation governing the manufacture of medicinal products in the EU/US.
LO2 Describe and design both compliance and systems audits in a pharmaceutical industrial environment.
LO3 Interpret the key legislation regarding the preparation of a marketing authorisation application.
LO4 Describe how a marketing authorisation is prepared, submitted and assessed.
 

Module Content & Assessment

No Course Work
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination   70.00 End-of-Semester

TU Dublin – Tallaght Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

This module has no Full Time workload.
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture No Description 1.50 Every Week 1.50
Independent Learning No Description 3.00 Every Week 3.00
Total Weekly Learner Workload 4.50
Total Weekly Contact Hours 1.50
 

Module Resources

Required Book Resources
  • EC Guidelines
  • Code of Federal Regulations
  • J Vesper 2000, GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Serentec Press
  • A.S. Lubiniecki and S.A. Vargo 1994, Regulatory Practice for Biopharmaceutical Productions
  • Rick Ng 2009, Drugs from Discovery to approval, 2nd Edition Ed., Wiley
This module does not have any article/paper resources
This module does not have any other resources
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SPHAR_D Bachelor of Science in Pharmaceutical Technology 6 Mandatory
TA_SMGRA_C Certificate in GMP & Regulatory Affairs (MIN) in GMP & Technology 1 Mandatory