Short Title:GMP 1/Quality Assurance
Full Title:GMP 1/Quality Assurance
Module Code:GMPQ H2005
 
Credits: 5
Field of Study:Pharmacy
Module Delivered in 1 programme(s)
Reviewed By:JOHN BEHAN
Module Author:ED CAREY
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 requirements for Good Manufacturing practices within the Pharmaceutical Industry.
LO2 Describe a quality documentation system and appropriate procedural structure.
LO3 Write a Standard Operating Procedure.
LO4 Describe the purpose of audits, corrective actions and change control etc. in a manufacturing environment.
LO5 Describe the role and function of Quality Control and Quality Assurance.
LO6 Describe the requirements of employees in delivering products, which meet specification standards.
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Assignment Write an SOP to perform a specific task or to describe the responsibility of a specific function. Develop a plan to introduce a GMP based system of operation to the working area. 1,3 40.00 Week 6
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,4,5,6 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 Classroom based lecture 2.00 Every Week 2.00
Assignment Write SOP and plan 1.00 Every Week 1.00
Independent Learning Research, preparation for exams and background reading 4.50 Every Week 4.50
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 Classroom based lecture 2.00 Every Week 2.00
Assignment Write SOP and plan 1.00 Every Week 1.00
Independent Learning Research, preparation for exams and background reading 4.50 Every Week 4.50
Total Weekly Learner Workload 7.50
Total Weekly Contact Hours 2.00
 

Module Resources

Required Book Resources
  • Code of Federal Regulations CFR211, FDA
  • Eudralex, Volume 4 Ed., EMEA
  • Vinay Bhatt, GMP Compliance, Productivity and Quality, Interpharm Press
This module does not have any article/paper resources
Other Resources
  • SOP's: Company Quality Manual, SOP’s
  • SOP's: Company Standard Operating Procedures (SOP’s) dealing with GMP audits
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SPRTC_C Higher Certificate in Science in Process Technologies 3 Mandatory