Short Title:GMP 1/Quality Assurance
Full Title:GMP 1/Quality Assurance
Module Code:QUAL H1002
 
Credits: 5
Field of Study:Pharmacy
Module Delivered in 4 programme(s)
Reviewed By:JOHN BEHAN
Module Author:MIRIAM O DONOGHUE
Module Description:This module aims to provide the student with: The necessary information to comply with the requirements of European Guidelines with respect to GMP and a knowledge of the requirements of with respect to GMP in the US.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Outline the necessity and function of GMP within industry.
LO2 Work under controlled conditions with documented procedures.
LO3 To write a simple Standard Operating Procedure.
LO4 Describe the role of audits, corrective actions and change control etc. in a manufacturing environment.
LO5 Demonstrate a knowledge of the role and function of Quality Control and Quality Assurance.
LO6 Describe the role of the employee in delivering products, which meet specification.
LO7 Interpretation and use of quality specifications.
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment Continuous Assessment in the form of assignments, online MCQs and online short questions will be used 1,2,3,4,5,6,7 40.00 Ongoing
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination   60.00 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
Directed Learning No Description 1.50 Every Week 1.50
Independent Learning No Description 3.00 Every Week 3.00
Total Weekly Learner Workload 6.00
Total Weekly Contact Hours 3.00
 

Module Resources

Required Book Resources
  • Vinay Bhatt, GMP Compliance, Productivity and Quality, Interpharm Press
Recommended Book Resources
  • Rick Ng 2009, Drugs, 2nd Edition Ed., Wiley-Blackwell Hoboken, N.J. [ISBN: 978-0-470-19510-9]
This module does not have any article/paper resources
Other Resources
  • website: Eudralex EU guide to GMPn/a
  • website: FDA Code of Federal Regulationsn/a
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SMABP_C Certificate in Bioprocessing and Cleanroom Management - Minor Award 1 Mandatory
TA_SMGRA_C Certificate in GMP & Regulatory Affairs (MIN) in GMP & Technology 1 Mandatory
TA_SMAGM_C Certificate in GMP and Medical Device Manufacture (Minor Award) 1 Mandatory
TA_SGMPT_C Higher Certificate in Science in GMP and Technology 1 Mandatory