Good Manufacturing Practice and Technology

Overview

Good Manufacturing Practice (GMP) ensures that medicinal products, medical devices and foods are consistently produced and controlled to the quality standards appropriate to their intended use.

A nationally accredited degree designed to meet the education and training needs of supervisors and higher technicians in the areas of Production, Quality Assurance and Validation in the Pharmaceutical, Biopharmaceutical, Chemical and Medical Device Industries.

The programme comprises of 11 modules and a Project. To complete the programme, each student must take the seven mandatory modules and 3 elective modules, as well as the project. A maximum of one free-choice elective may be chosen. The project is undertaken towards the end of the degree programme, when the student has successfully completed seven of the modules. The programme can be taken over two years or spread out over three or more years. There is a considerable element of continuous assessment. Laboratory experiments are included in appropriate modules.

Award

On successful completion of the full programme of study: Bachelor of Science in Good Manufacturing Practice and Technology (Level 7 on the National Framework of Qualifications).

What will I study?

Semester 1

• STAT7004 - Process Improvement
• MGMT7060 - People Management

Semester 2

• MANU7007 - Validation Science
• BIOT7005 - Biopharmaceutical Downstream

Indicative Content

• Validation Science
• Manufacturing Operations
• Chemical Applications
• Technology Transfer
• Maintenance, Utilities and Facilities
• Biopharmaceutical Upstream
• People Management
• Process Improvement
• Biopharmaceutical Downstream
• Energy Management
• Project
• Formulation
• Food Processing Technology
• Introduction to Biomedical Devices
• Biomedical Manufacture

Entry Requirements

Candidates are required to have a Higher Certificate or higher in an Engineering or Science Discipline (minimum 120 credits).  It is required that all qualifying candidates have completed modules in basic chemistry and biology (Level 6), and have a knowledge of GMP, to undertake the complete programme. A Level 6 mathematics module must be part of the qualification.

There are two routes of entry into this BSc course: Direct Entry and Advanced Entry.

Direct Entry to the BSc in GMP & Technology

Students must meet the above admission requirements.

Advanced Entry to the BSc in GMP & Technology

This route was developed for individuals who have relevant industrial experience seeking to gain a Bachelor of Science degree.

Students complete a technical portfolio which must be approved for entry into the BSc. The Recognition of Prior Learning (RPL) assists the students in the preparation of this. 

The technical portfolio must prove evidence to support the completion of

1. Leaving Certificate Grade O6/H7 (pre. 2017, Grade D3 Ordinary Level) in five subjects. The five subjects must include English or Irish, and Mathematics.

 

2. Five years or more relevant work experience in the pharmaceutical, biopharmaceutical, medical device or food industry. To prove the relevance of their application the candidate will need to show that they are familiar with the topics covered in the following modules:
 

• Calibration Science
• Lean Manufacturing
• Manufacturing Technology
• Cleanroom Management
• GMP1/QA
• Information Technology
• Contamination Control
• Essential Maths Skills

3. Special Purpose Award in the Certificate in the Science of Biotechnological Manufacturing Operations or equivalent.

Note: The running of individual modules will be dependent on a sufficient number of students enrolling on the course. The module may be withdrawn if this requirement is not fulfilled.

Please attach and upload any documents such as transcripts, CV, other details relevant to the application.

Fees

€500 per 5-credit module

Please note that applicants will be required to pay an acceptance fee of €500 online if a place on a course is offered. This fee is deductible from the overall course fee.

Note: You will not be charged for applying for the programme by clicking the 'apply now' button, you are only asked to pay an acceptance fee if a place is offered to you and you wish to accept it.

Career options

Examples of career roles include:

• Quality Assurance Specialist
• Process Technician
• Environmental Chemist
• Validation Engineer
• Manufacturing Support
• Commissioning Qualification Specialist
• Quality Technician