Short Title:GMP2/Quality Control
Full Title:GMP2/Quality Control
Module Code:GMPQ H2006
 
Credits: 5
Field of Study:Pharmacy
Module Delivered in 1 programme(s)
Reviewed By:JOHN BEHAN
Module Author:ED CAREY
Module Description:To develop students competency in identifying, interpreting and applying cGMP guidelines and healthcare/pharmaceutical regulations, specifically within the Quality Control area and give them an understanding of sampling and some analytical methods.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Identify the agencies which regulate healthcare manufacturing.
LO2 Describe how regulatory documentation is identified and managed.
LO3 Describe the principles of validation.
LO4 Describe the QC testing pathway.
LO5 Interpret QC specifications of ingredients, components and products.
LO6 Write a QC test procedure for a component or a raw material.
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment Assignment 6 40.00 Week 8
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 60.00 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 based learning 2.00 Every Week 2.00
Independent Learning Review of lecture notes, research and preparation for exams 4.50 Every Week 4.50
Assignment Complete assigned project 1.00 Every Week 1.00
Total Weekly Learner Workload 7.50
Total Weekly Contact Hours 2.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Lecture based learning 2.00 Every Week 2.00
Independent Learning Review of lecture notes, research and preparation for exams 4.50 Every Week 4.50
Assignment Complete assigned project 1.00 Every Week 1.00
Total Weekly Learner Workload 7.50
Total Weekly Contact Hours 2.00
 

Module Resources

Required Book Resources
  • Code of Federal Regulations USFDA for the manufacture of sterile pharmaceuticals.
  • J. Vesper 2000, GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Serentec Press [ISBN: 1930114176]
  • Bhatt V, GMP Compliance, Productivity and Quality, Interpharm press
  • ICHQ7 GMP for Active Pharmaceutical Ingredients, ICH
  • US Pharmaceutical, Interpharm Press
Required Article/Paper Resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SPRTC_C Higher Certificate in Science in Process Technologies 4 Mandatory