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13 May 2019 | Story Zama Feni | Photo Charl Devenish
Dr Quinton Meyer and Marlena Visagie
National Control Laboratory Deputy Director, Dr Quinton Meyer (right), and Marlena Visagie, Quality Assurance Manager, at the laboratory within their facilities at the University of the Free State.

The University of the Free State-based National Control Laboratory for Biological Products (NCL) has maintained its esteemed status as a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) further endorsed its quality-management systems as of high standard according to the International Standards Organisation’s requirements.

The Director of the NCL, Professor Derek Litthauer, said their laboratory – which is also approved by the World Health Organisation (WHO) – has again achieved the international testing standards. The cherry on top was that the NCL also received a certificate of Good Manufacturing Compliance (GMP) from the South African Health Products Regulatory Authority (SAHPRA). 

NCL is for Africa and the World 

Some of the factors that make the NCL an esteemed institution, is the fact that it is one of 12 laboratories worldwide to perform vaccine testing for the WHO; the NCL is the only vaccine-testing laboratory in the country that performs the final quality-control testing of all human vaccine batches marketed in South Africa on behalf of SAHPRA. 

For example, Prof Litthauer said that the influenza vaccine batches currently available on the South African market, were tested by the NCL for quality before authorising their release for sale to the public. This process is followed for all human vaccines used in SA.

 “In our role as vaccine-testing laboratory for the WHO, the NCL helps to ensure that the vaccines purchased through the WHO prequalification programme for international distribution to resource-limited countries, meet the high standards of quality, safety, and efficiency. 
The NCL was one of the first full members of the WHO NCL Network for Biologicals, which consists of full and associate members of regulatory authorities from more than 30 countries.

The NCL systems are world-class

Prof Litthauer said this achievement is recognition that their laboratory complies with specific international standards with respect to its quality-management system. 
“In practice, it means that the laboratory has all the quality systems in place to ensure high-quality test results. The GMP certification is a further step, meaning that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. It is a very strict certification.”

He further mentioned that the NCL is also licensed as a pharmaceutical manufacturer. “Although we do not manufacture, we have to comply with manufacturing standards.”
“It is rare for a pharmaceutical testing laboratory (such as the NCL) outside of a manufacturing context to qualify for both certifications. It means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world,” he said.
The certification provides the South African Health Products Regulatory Authority, the World Health Organisation, and other national control laboratories around the world, with the confidence that the test results from the NCL can be trusted.


There can be no compromise for quality 

The NCL Quality Assurance Manager, Mrs Marlena Visagie, said, “It is essential that the NCL complies with the highest international quality-assurance standards to ensure that all the lot-release operations, such as manufacturing review and quality testing, are performed in a reliable and reproducible manner.”

“There can be no compromise when it comes to the quality of medicines which are made available to the public,” she said.

“What makes this special, is that the NCL does not only comply with international ISO/IEC standards for pharmaceutical testing, but also with the additional GMP standards required by a pharmaceutical manufacturer. This means that the NCL must ensure that all its operations, including everything from the way documents are compiled and stored, to the maintenance of equipment and infrastructure as well as staff competency, are performed according to international guidelines.”

All NCL staff share vision of excellence

Prof Litthauer said the NCL has a staff complement of 15 technical, administrative, and support staff.  Four staff members have PhDs, and the rest of the technical staff have master’s or bachelor’s degrees or are trained as medical technologists. “At the moment, our biggest problem is to get enough suitable space to expand our testing,” he said.

Prof Litthauer said, “All the staff members at the NCL share the vision of excellence, which makes this kind of achievement possible.”
The NCL will host the third annual meeting of the WHO NCL Network in November of this year and will then be reassessed again by the WHO as part of the normal three-year cycle of assessments.  

News Archive

Change and growth at the University of the Free State
2011-07-04

 

Graphical representation of the High Performance Centre

“Come gather round people, wherever you roam. And admit that the waters around you have grown…”

These are the opening lines of Bob Dylan’s iconic single The times they are-a changing. They are also extremely apt words to describe the excitement about the winds of change and growth blowing across the University of the Free State, not only academically, but also physically.

Over the past few months there has been non-stop construction and growth of a physical nature, with several new buildings being erected and new sculptures rising up all over the Bloemfontein Campus.

The most visible and probably the most striking of all the new structures is the brand-new main entrance to the campus. This stunning new feature welcomes visitors to the campus in Nelson Mandela Drive, in the colours of each of the university’s seven faculties.

Once through this beautiful new gate, visitors have a choice of new and exciting features to explore on the campus.

The first is the brand new climbing wall, which is located against the West Block and Chemistry Buildings. This new addition to the campus is available for use by all enthusiasts of this exciting sport.

The Office of the Dean of Student Affairs manages the administration of the wall and students who want to climb can book at their office in the Student Centre at the Thakaneng Bridge. In order to ensure that students do not use the wall without permission, and to prevent accidents, the wall is covered by a tarpaulin, which is locked when the wall is not in use.

Next on the list of new developments is the high-performance gymnasium which is currently still under construction. With this project the university wants to create a work environment for its staff that will not only contribute to the cultivation of maximum work performance, but also to staff wellness.

The centre with its foyer and administrative offices will also consist of a health desk, university sports institute, sports sales, a spinning and aerobic centre, and dressing rooms. The total area will extend more than 2114 m².

Progress on other building projects, which commenced last year, is also very pleasing. One of the projects is a new Education Building which is being constructed opposite the UFS Sasol Library. Upon completion, this building will be used for the training of maths and science teachers in the Foundation Phase. It will include three classrooms for 100 students each and an auditorium for 225 students as well as an office block. The auditorium will also be used as a classroom. The building has been designed according to environmentally friendly principles to save water and use power effectively. Construction is going swimmingly and should be completed soon.

Planning for the construction of more student accommodation on the Bloemfontein Campus as well as the Qwaqwa Campus is also well underway. On the Qwaqwa Campus, a residence with 200 beds is being constructed. This also includes a computer laboratory. According to the planning, this residence is near completion. Furthermore, four residences will be constructed on the Bloemfontein Campus. These residences are in the planning phase.

In order to place technology within reach of Kovsie students and thereby empowering them, computer laboratories were installed at all residences. The computer laboratories will eventually make provision for approximately185 computers for student use. Proper security is also planned to safeguard the equipment.
A brand-new building for the Faculty of Health Sciences is also proceeding rapidly. This building will include a lecture hall for 200 students, five venues for 100 students each, as well as offices. Students from the School for Medicine and Occupational Therapy will make use of these facilities.

The new building for the Faculty of Economic and Management Sciences between the Flippie Groenewoud Building and the Wynand Mouton Theatre is also coming along nicely.

On the university’s Qwaqwa Campus a new Education building is being constructed. This building will include a lecturing hall with 100 seats, four 50-seat classrooms, six offices, ablution facilities, biology and science laboratory, as well as an information technology laboratory for 60 students.

In the meantime, existing buildings are being renovated on all the campuses. This includes, amongst others, improvements to the Architecture Building, the Biotechnology Building and the quarters for service workers on the Bloemfontein Campus. Other improvements that have already been completed include renovations to the Odeion’s foyer and the Callie Human Centre.

A special memorial park for women, residential accommodation within a sports environment, and a botanical garden are also among the beautiful, exciting new sites to be seen on the campus.

Coupled with all the beautiful sculptures, funded by the Lotto Sculpture project, our university’s campuses will soon be a more vibrant, beautiful attraction.
 

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