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MGMT6021 - cGMP 1 & Quality Assurance

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Title:cGMP 1 & Quality Assurance
Long Title:cGMP 1 & Quality Assurance
Module Code:MGMT6021
 
Credits: 5
NFQ Level:Fundamental
Field of Study: Chemical & Process Eng
Valid From: Semester 1 - 2013/14 ( September 2013 )
Module Delivered in 5 programme(s)
Module Coordinator: MICHAEL J O MAHONY
Module Author: ANN TOEBES
Module Description: This module includes an overview of Quality Management, Good Manufacturing Practices, and the role of regulatory bodies in the healthcare industries. It details the requirements for documentation, change control, validation, deviation and complaints management, auditing and training.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the principles of quality management.
LO2 Outline the necessity for, and function and impact of GMP within industry.
LO3 Explain the importance of documentation, including change control processes, and write a standard operating procedure.
LO4 Explain the role of training in the consistent manufacture of high quality products.
LO5 Describe the processes used to manage non-conformances and improvement opportunities in a GMP environment.
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).
None
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
Requirements

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.

None
Co-requisites
No Co Requisites listed
 

Module Content & Assessment

Indicative Content
Quality
Define quality. Quality and competitiveness. Quality costs as a driving force. Define quality assurance. Quality policy, quality management systems, building quality into the product. Differentiate between quality control and quality assurance. Quality culture and ethics.
Overview of GMP and GMP Principles
Define GMP. Review the principles of GMP. The role & function of the various regulatory bodies e.g. FDA, European Commission, IMB, EPA, HSA. Review how GMP is implemented in the workplace. The role of the employee in delivering quality products. Introduction to GMP regulations and validation.
Documentation and Change Control
The importance of documentation, types of documents such as standard operating procedures (SOPs), specifications, batch manufacturing records, deviation reports, etc. Writing and controlling official procedures. Edition, numbers, revision numbers, document status. Control and distribution of documents. Storing, retrieving and updating documents. The change control process, types of change control.
Non-conformances and Improvement Opportunities
Auditing: the principles of auditing. Analysis of the steps involved in auditing manufacturing environments. Internal and external audits. Audit reports and corrective actions. Complaints: management of complaints and using complaints as a means to improve systems and processes. Deviation reporting: explain what deviations are, how they occur, and how they are processed.
Training
The importance of training in controlled manufacturing environments. GMP requirements of training. Different training methods. Maintenance of training records.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Essay Assignment 1,2 20.0 Week 4
Project Case Study/Site Visit 2,3,4,5 20.0 Week 8
Multiple Choice Questions Assessment 1,2,3,4,5 30.0 Week 12
Practical/Skills Evaluation Compilation of practical work completed during semester 3,4,5 30.0 Every Week
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 4.0 Every Week 4.00
Independent & Directed Learning (Non-contact) Student study and report writing 3.0 Every Week 3.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom Instruction 4.0 Every Week 4.00
Independent & Directed Learning (Non-contact) Student study of course material and report writing 3.0 Every Week 3.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
 

Module Resources

Recommended Book Resources
  • John Sharp 2005, Good pharmaceutical manufacturing practice, Boca Raton, Fla. : CRC Press. [ISBN: 0849319943]
Supplementary Book Resources
  • James L. Vesper, Documentation Systems [ISBN: 1574910507]
  • James L. Vesper, Quality and Gmp Auditing [ISBN: 1574910558]
This module does not have any article/paper resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_ECBPO_6 Certificate in Chemical and Biopharmaceutical Process Operations 1 Mandatory
CR_EFDMO_6 Certificate in Food Manufacturing Operations 1 Mandatory
CR_EFDPF_6 Certificate in Food Processing Fundamentals 1 Elective
CR_SGMPP_6 Certificate in GMP and Process Operations 1 Mandatory
CR_SGMPR_6 Higher Certificate in Science in Good Manufacturing Practice and Technology 1 Mandatory

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