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Global body re-affirms UFS lab’s vaccine testing status

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

Eye tracker device a first in Africa

2013-07-31

31 July 2013

Keeping an eye on empowerment

"If we can see what you see, we can think what you think."

Eye-tracking used to be one of those fabulous science-fiction inventions, along with Superman-like bionic ability. Could you really use the movement of your eyes to read people's minds? Or drive your car? Or transfix your enemy with a laser-beam?

Well, actually, yes, you can (apart, perhaps, from the laser beam… ). An eye tracker is not something from science fiction; it actually exists, and is widely used around the world for a number of purposes.

Simply put, an eye tracker is a device for measuring eye positions and eye movement. Its most obvious use is in marketing, to find out what people are looking at (when they see an advertisement, for instance, or when they are wandering along a supermarket aisle). The eye tracker measures where people look first, what attracts their attention, and what they look at the longest. It is used extensively in developed countries to predict consumer behaviour, based on what – literally – catches the eye.

On a more serious level, psychologists, therapists and educators can also use this device for a number of applications, such as analysis and education. And – most excitingly – eye tracking can be used by disabled people to use a computer and thereby operate a number of devices and machines. Impaired or disabled people can use eye tracking to get a whole new lease on life.

In South Africa and other developing countries, however, eye tracking is not widely used. Even though off-the-shelf webcams and open-source software can be obtained extremely cheaply, they are complex to use and the quality cannot be guaranteed. Specialist high-quality eye-tracking devices have to be imported, and they are extremely expensive – or rather – they used to be. Not anymore.

The Department of Computer Science and Informatics (CSI) at the University of the Free State has succeeded in developing a high-quality eye tracker at a fraction of the cost of the imported devices. Along with the hardware, the department has also developed specialised software for a number of applications. These would be useful for graphic designers, marketers, analysts, cognitive psychologists, language specialists, ophthalmologists, radiographers, occupational and speech therapists, and people with disabilities. In the not-too-distant future, even fleet owners and drivers would be able to use this technology.

"The research team at CSI has many years of eye-tracking experience," says team leader Prof Pieter Blignaut, "both with the technical aspect as well as the practical aspect. We also provide a multi-dimensional service to clients that includes the equipment, training and support. We even provide feedback to users.

"We have a basic desktop model available that can be used for research, and can be adapted so that people can interact with a computer. It will be possible in future to design a device that would be able to operate a wheelchair. We are working on a model incorporated into a pair of glasses which will provide gaze analysis for people in their natural surroundings, for instance when driving a vehicle.

"Up till now, the imported models have been too expensive," he continues. "But with our system, the technology is now within reach for anyone who needs it. This could lead to economic expansion and job creation."

The University of the Free State is the first manufacturer of eye-tracking devices in Africa, and Blignaut hopes that the project will contribute to nation-building and empowerment.

"The biggest advantage is that we now have a local manufacturer providing a quality product with local training and support."

In an eye-tracking device, a tiny infra-red light shines on the eye and causes a reflection which is picked up by a high-resolution camera. Every eye movement causes a change in the reflection, which is then mapped. Infra-red light is not harmful to the eye and is not even noticed. Eye movement is then completely natural.

Based on eye movements, a researcher can study cognitive patterns, driver behaviour, attention spans, even thinking patterns. A disabled person could use their eye-movements to interact with a computer, with future technology (still in development) that would enable that computer to control a wheelchair or operate machinery.

The UFS recently initiated the foundation of an eye-tracking interest group for South Africa (ETSA) and sponsor a biennial-eye tracking conference. Their website can be found at www.eyetrackingsa.co.za.

“Eye tracking is an amazing tool for empowerment and development in Africa, “ says Blignaut, “but it is not used as much as it should be, because it is seen as too expensive. We are trying to bring this technology within the reach of anyone and everyone who needs it.”

Issued by: Lacea Loader
Director: Strategic Communication

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