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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

State-of-the-art physics equipment and investment in students result in academic success
2017-09-26

Description: State-of-the-art physics equipment 1 Tags: State-of-the-art physics equipment 1 

At the recent nanotechnology facility tour at the UFS,
were, from the left, Dr Mthuthuzeli Zamxaka, SAASTA;
Prof Hendrik Swart, Sarchi Chair in the Department of Physics;
and Xolani Makhoba, Department of Science and Technology.
Photo: Leonie Bolleurs

Nanoscience, which is revealing new properties of very small arrangements of atoms, called nanoparticles, is opening a new world of possibilities. The Department of Physics at the University of the Free State is undertaking fundamental research with potential commercial applications. Its equipment and expertise is giving solid state physics research the edge in South Africa.

The UFS team of researchers and students are passionate about studying planets and atoms, all under one roof. Recently, the department, in collaboration with the South African Agency for Science and Technology Advancement (SAASTA), hosted a nanotechnology facility tour to give the public, learners and the media the opportunity to familiarise themselves with the science of nanotechnology, its origins, potential applications and risks.

Successes of the department
According to Prof Hendrik Swart, Senior Professor in the Department of Physics, the increase in resources since 2008 is playing a big role in the success rate of its research outputs. The Sarchi Chair awarded to Prof Swart in 2012 (bringing with it funding for equipment and bursaries) also contributed to the successes in the department.

The UFS Directorate Research Development also availed funding that was used for bursaries. These bursaries made it possible for the department to appoint 10 post-doctoral fellows, not one of them originally from South Africa.

The investment in people and equipment resulted in researchers and students publishing some 80 articles in 2016. Their work was also cited more than 900 times by other researchers in that year.

Another highlight in terms of the department’s growth in the past 10 years is the new wing of the Physics Building. Physics at the UFS is the only place in sub-Saharan Africa where state-of-the art equipment is found under one roof.

Description: State-of-the-art physics equipment 2 Tags: State-of-the-art physics equipment 2  

Antonie Fourie, Junior Lecturer in the UFS Department of
Physics, explained to a group of delegates and
members of the media the workings of an electron beam
evaporation system.
Photo: Leonie Bolleurs

Application of research
The department is a unique research facility with equipment that includes the X-ray Photoelectron Spectrometer (for the study of atoms), the Scanning Auger Microscope, as well as the Ion Time-of-Flight Secondary Ion Mass Spectrometer (revealing the chemical bonds in a sample, and drawing maps of the positions of atoms).

One of the areas on which the department is focusing its research, is phosphors. Researchers are exploring light emitting diodes (LEDs) which use less energy, are brighter and provide a wider viewing field. They are also looking into LED displays (LCDs) which are used in flat screens – the phosphors create the different colours and backlighting.

The research on solar cells reveals that phosphors can increase their efficiency by increasing the range of light frequencies which can be converted into electricity. Glow-in-the-dark coatings absorb light in the day and emit it later so cells can charge at night. As glow-in-the-dark phosphors become cheaper and more effective, they can be used as a lighting substitute on the walls of houses, street numbers and stop signs.

Video production of the Department of Physics research and equipment

 

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