Good Manufacturing Practice & Technology

Assessment
*the modules  are assessed by 100% Continuous Assessment.
The numbers in brackets are the projected class content times in hours per week.
The remaining modules are assessed by Continuous assessment and a final examination.
Assessment can take the form of written assignments, class tests, case studies and laboratory.
The module ‘Manufacturing & Processing’ is assessed by 100% final examination.

Year 1

Semester 1	Semester 2
Core Competencies* (1), 5 credit module	Introduction to Pharmaceutical Analysis (2), 10 credit module
Fundamentals of Chemistry (2), 10 credit module	Fundamentals of Biology (2), 10 credit module
Maths for GMP (2), 10 credit module	Measurement Science (2), 10 credit module
GMP1 *, 5 credit module

Year 2

Semester 3	Semester 4
Introduction to Pharmaceutical Science *(2), 10 credit module	Total Quality Management *(2), 5 credit module
Contamination Control / Cleanroom Management (2), 10 credit module	Calibration Science* (2), 5 credit module
Manufacturing and Processing I (2), 10 credit module	GMP2 *(2), 10 credit module
	Work Based Project*, 10 credit module

Leaving Certificate or equivalent. Candidates must be employed in biopharma or medTech as a work-based project is required.

Graduates can progress to the Level 7 Bachelor of Science Ordinary Degree in Good Manufacturing Practice & Technology.

Testimonials from graduates of the Higher Certificate and a Bachelors Degree in Good Manufacturing Practice and Technology

"I began working in the pharmaceutical industry in 2010 and the Higher Cert in GMP and Technology course at SETU was recommended to me by some of my colleagues who had already completed the course.  

Having never studied a science subject previously, it was a big undertaking.  However, I need not have worried, the course is designed for people who have the willingness to learn.  It gives an insight into both the analytical and manufacturing areas of the pharmaceutical industry. I gained valuable knowledge in relation to manufacturing processes, laboratory techniques and good manufacturing practices.  The lecturers were friendly, approachable and very helpful.

Whilst completing the course, I gained a great understanding of the pharmaceutical processes from raw material manufacture, laboratory testing through to product manufacture and packing and the various regulatory and quality impacts.  This helped to give me a better understanding of all aspects of the business in which I work.

I would recommend this course to anyone currently working in the pharmaceutical industry as a great way of enhancing your knowledge and developing your skills and your career within the industry."

-Gillian Kelly, Purchasing & Planning Co-ordinator, EirGen Pharma

"In 2007 I began a career in the Pharmaceutical industry having previously worked in manufacturing. I needed to learn and understand the fundamentals behind cGMP and see where it could take me as a career. I decided to invest in 3rd level education and the Higher Cert in Science Good Manufacturing Practice and Technology was the perfect introduction which allowed me form a foundation of knowledge that could progress into the degree course.

The course allowed me to gain valuable knowledge in the cGMP area that I could apply to my everyday tasks. The leanings provided me with the confidence to take on new responsibilities and raise my profile within the company. The modules covered in the course offered a chance to learn about various subjects and also aided in improving my technical writing abilities.

For anyone considering starting a career or furthering their career in Pharmaceuticals I would highly recommend this course. As a result of completing it I have transitioned through various roles in my company and am now currently in a position of Team Leadership which has definitely been enhanced directly by the course."

-Ray Kelly, Packaging Team Leader, Genzyme, A Sanofi Company

"Returning to education as a part-time student has greatly improved my life. Not only has it enhanced my outlook, but has also increased my friendships, improved my working qualifications and given me an overall sense of achievement, accordingly to Kelly Tobin from Clonmel - a student on the Bachelor of Science in Good Manufacturing Practice and Technology at South East Technological University. 

I have worked for an excellent medical device company for the past eight years. I have been able to move roles throughout the organisation because of my new qualifications, and my studies will help me to transfer to my ideal job in the future."

-Kelly Tobin, Medical Device Company Employee

"The decision to commence the BSc in GMP and Manufacturing course was not an easy one, but once it was made, I did not regret it for a minute. The course hours are work-friendly and, while commitment is required, the tutors are supportive and always willing to help.

The course gave me an insight into both the analytical and the manufacturing side of pharmaceutical processes. It also deepened my GMP/Quality Assurance and Compliance knowledge. Most importantly, it gave me the confidence and the  qualification required to develop my career within the pharmaceutical industry. Within a year of completion, I was promoted to a Team Leader position within the group I was working in. The spectrum of tasks I was assigned increased greatly and I was exposed to a number of new ones; got involved in a wide variety of projects. I believe that those opportunities would not have been given to me was I not a graduate of the GMP degree course. 

This course is also a fantastic basis for further educational development and I have been already thinking and planning my further steps."

-Agnieska Mickiewicz, Team Leader, R&D Laboratory, Teva