Short Title:GMP2/Quality Control
Full Title:GMP2/Quality Control
Module Code:QUAL H2040
 
Credits: 5
Field of Study:Pharmacy
Module Delivered in 3 programme(s)
Reviewed By:JOHN BEHAN
Module Author:MIRIAM O DONOGHUE
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 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 and non conformance reports.
LO7 Report defects and define the status of ingredients components and products.
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment Assignments and on-line assessments 1,2,3,4,5,6 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
  • 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]
  • L. Steinborn 1995, GMP – ISO 9000 Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Interpharm Press [ISBN: 0935184651]
  • A.S. Lubiniecki and S.A. Vargo 1994, Regulatory Practice for Biopharmaceutical Production
  • Bhatt V, GMP Compliance, Productivity and Quality, Interpharm press
  • 2000, Guidelines on GMP for Active Pharmaceutical Ingredients, ICH
  • US Pharmaceutical, Interpharm Press
This module does not have any article/paper resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
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) 2 Mandatory
TA_SGMPT_C Higher Certificate in Science in GMP and Technology 4 Mandatory