Full Title:Good Manufacturing Practice (GMP) and Regulatory Affairs
Module Code:QUAL S7010
Credits: 5
Valid From:Semester 1 - 2013/14 ( September 2013 )
Module Delivered in 4 programme(s)
Module Description:The aims of this module are: - To give students an understanding of the process of new drug discovery and development. - To provide students with an in-depth knowledge of the important role that Good Manufacturing Practice (GMP) plays in risk reduction.
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Describe and assess the suitability and pre-clinical characterisation of biopharmaceutical drug candidates.
  2. Define and evaluate a variety of drug delivery systems and the drug-testing process (incl. pre-clinical and clinical trials)
  3. Identify and interpret Good Manufacturing Practices and their increasing importance in the development and manufacture of drugs
  4. Examine and discuss the (international) regulatory environment and the role of regulatory authorities in evaluating and approving drug candidates.

Module Content & Assessment

Indicative Content
Biopharmaceutical Drug Development and Registration:
Knowledge based drug development, history of the discovery of some major biopharmaceuticals. Identification and characterisation of potential biopharmaceuticals.
Overview of Pre-clinical studies:
Purpose of pre-clinical studies: Pharmaco-kinetics and pharmaco-dynamics. Safety and toxicity analysis of (novel) compounds. The use of in vitro and in vivo analysis of (novel) compounds.
Overview of Clinical Trials:
Purpose of clinical trials: Clinical trial design. Introduction to trial size and study population, trial designs and methods of study controls (e.g. randomised, historical and cross-over trial design and blinding). Phase I, II, and III clinical trials.
Good Manufacturing Practices:
The increasing importance of GMP in the development and manufacture of drugs is outlined and put into context. An outline of the increasing (GMP) demands as products become more defined and closer to their point of use in human therapy are provided.
Manufacturing Requirements:
Quality management, Personnel, Premises and Equipment technologies (including contamination containment & classifications and clean-room technologies). Documentation, Production processes and critical control points, Quality Control and Quality Assurance, Validation (facilities, processes, cleaning, DQ, IQ, OQ, PQ). Dealing with Complaints, Self Inspections and Auditing. LIMS.
Key GMP aspects for control and risk reduction:
Sources of contamination and product contact, sterility, personal safety, packaging and labelling of medical interventions (e.g. drugs / medical devices).
Overview of the role and remit of Regulatory Authorities:
Review of the FDA (USA), EMA (EU) and IMB (IE): Structure and mission, role in the (bio)pharmaceutical drug development and approval process. Drug distribution and drug marketing authorisations (incl. IND & NDA applications)
Assessment Breakdown%
Course Work30.00%
End of Module Formal Examination70.00%

Full Time

Course Work
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Group Project Students will be asked to take a new ('invented') drug (or medical intervention) through all regulatory stages required for market approval. Assessment will be based on group-report, presentation and/or individual assignment. 2,4 30.00 0 0 Week 12 0
No Project
No Practical
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Formal Exam End-of-Semester Final Examination 1,2,3,4 70.00 0 0 End-of-Semester 0
Reassessment Requirement
A repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

DKIT reserves the right to alter the nature and timings of assessment


Module Workload & Resources

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Directed Reading n/a 2.00 Every Month 0.50
Tutorial n/a 1.00 Every Week 1.00
Lecture n/a 2.00 Every Week 2.00
Independent Study n/a 5.00 Every Week 5.00
Total Weekly Learner Workload 8.50
Total Weekly Contact Hours 3.00
This course has no Part Time workload.
Recommended Book Resources
  • Rathore, A.S. and Mhatre, R 2008, Quality by Design for Biopharmaceuticals: Principles and Case Studies, J. Wiley & Sons
  • Nally, J.D. 2007, Good Manufacturing Practices for Pharmaceuticals., 6th Ed., Informa Healthcare (U.S.A.)
  • Rathore, A.S. 2013, Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, J. Wiley & Sons
  • Commission of the European Communities, The rules governing medicinal products in the European Community, A multi-volume work (various publication dates). Published by the European Commission, Brussels.
  • World Health Organisation 2007, Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, WHO
This module does not have any article/paper resources
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
DK_SAPBI_7 Bachelor of Science in Applied Bioscience 5 Mandatory
DK_SPHAR_7 Bachelor of Science in Pharmaceutical Science 5 Mandatory
DK_SGMPP_7 Certificate in GMP in Pharmaceutical Manufacturing 1 Mandatory
DK_SBIOP_8a Diploma in Biopharmaceutical Processing 1 Mandatory