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CHEP6004 - cGMP 2 and Quality Control

Title:cGMP 2 and Quality Control
Long Title:cGMP 2 and Quality Control
Module Code:CHEP6004
Duration:1 Semester
Credits: 5
NFQ Level:Fundamental
Field of Study: Chemical & Process Eng
Valid From: Semester 1 - 2014/15 ( September 2014 )
Module Delivered in 2 programme(s)
Module Coordinator: NIALL MORRIS
Module Author: ANN TOEBES
Module Description: This module covers the main GMP regulations and guidelines as they relate to the pharmaceutical and medical devices industries. The process of product registration is introduced. The role and function of quality control explored along with the concept of sampling and the steps in OOS investigations. The concepts and principles involved are explored interactively in case studies.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Discuss how GMP regulations have developed and describe the current issues affecting the healthcare sector.
LO2 Explain the steps of pharmaceutical and medical device registration.
LO3 Source and interpret directives, guidelines and documents regulating pharmaceutical and medical device manufacture.
LO4 Identify the role and functions of the Quality Control in manufacturing. Review the QC testing pathway and describe common test methods employed by QC.
LO5 Explain the elements of effective sampling and prepare a sampling plan.
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
9446 MGMT6021 cGMP 1 & Quality Assurance
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.


Module Content & Assessment

Indicative Content
Current topics
Overview of events such as the Thalidomide disaster and the Transmissible Spongiform Encephalopathy crisis and their impact on regulation. Globalisation of the pharmaceutical and medical device sectors, implications for control of the industries. Counterfeiting. Patents. Orphan Medicines. Generics and biosimilars. Purchasing medicines online. Review of current issues.
Product Authorisation
Steps in the approval of medicines and medical devices. Licencing of patented medicines, generic medicines and biosimilars.
GMP Regulations and Guidelines
Review of EU and FDA directives, regulations and guidelines on the control of medicine or medical device manufacture. Function of the International Conference on Harmonisation (ICH) or International Medical Device Regulators Forum. Review of recent recalls and warning letters. Introduction to validation.
Quality Control
Role of Quality Control, implementation of GMP regulations in QC (appropriate documention, auditing, training etc.). Pharmacopoeia. Sampling, OC curves, sampling plans, sampling tables. Review of commonly used QC tests. Retain samples. Stability programmes. Managing Quality: testing pathway, sample storage. Out of Specification (OOS) Investigations. Laboratory Information Management Systems. Process Analytical Technology. Quality reviews.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Written Report Company Visit 1,3,4 20.0 Week 4
Presentation Preparation and delivery of a presentation on a QC test method. 4 20.0 Week 7
Short Answer Questions Theory Assessment 1,2,3,4 30.0 Week 10
Practical/Skills Evaluation Preparation of a portfolio of learning throughout the semester. 1,2,5 30.0 Sem End
No End of Module Formal Examination
Reassessment Requirement
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.

The institute 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 Instruction 3.0 Every Week 3.00
Independent & Directed Learning (Non-contact) Student Study 4.0 Every Week 4.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom Instruction 3.0 Every Week 3.00
Independent & Directed Learning (Non-contact) Student Learning 4.0 Every Week 4.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00

Module Resources

Recommended Book Resources
  • MHRA 2013, Rules and Compliance for Pharmaceutical Manufacturers and Distributors, Pharmaceutical Press [ISBN: -10: 0857111027]
  • Burgess C 2000, Valid Analytical Methods and Procedures, Cambridge: Royal Society of Chemistry [ISBN: 0854044825]
  • WHO 2006, International Pharmacopoeia, 4th Ed. [ISBN: 2 VOLUMES: 924156301X - 9789241563017]
Supplementary Book Resources
  • Robert A. Nash, Alfred H Wachter, Marcel Dekker 2003, Pharmaceutical Process Validation [ISBN: 0-8247-0838-5]
This module does not have any article/paper resources
Other Resources
  • Hard or Soft Copy: Course Notes
  • Website: Food and Drug Administrationwww.fda.gov
  • Website: European Medicines Agencyn/a
  • Website: Health Products Regulatory Authoritywww.hpra.ie
  • Website: International Conference on Harmonisationwww.ich.org
  • Website: International Medical Device Regulators Forumn/a
  • Website: Irish Business and Employers Confederationwww.ibec.ie

Module Delivered in

Programme Code Programme Semester Delivery
CR_ECBPO_6 Certificate in Chemical and Biopharmaceutical Process Operations 2 Mandatory
CR_SGMPR_6 Higher Certificate in Science in Good Manufacturing Practice and Technology 2 Group Elective 1

Cork Institute of Technology
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