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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

The solution to student food insecurity is a holistic approach
2017-02-10

Description: Dietetics read more Tags: Dietetics read more

Dr Louise van den Berg from the Department of
Nutrition and Dietetics says the University of the Free State
is taking steps to teach students how to budget and make
them aware how important food nutrition is.
Photo: Pixabay 

Research at the University of the Free State (UFS) has indicated that nearly 60% of students are victims of food insecurity and suffer from hunger most of the time. The research by the UFS Faculty of Health Sciences shows that a further 25% are food insecure but are not hungry most of the time.

Senior Lecturer in the Department of Nutrition and Dietetics, Dr Louise van den Berg, says food insecurity is common among student populations across the world. However, local research shows that it is almost double that of tertiary institutions in developed countries.

Food insecurity among students caught many people off-guard
Dr Van den Berg says in South Africa nobody had really looked at the problem until recently “It seems student food insecurity has caught many people off-guard.” She says people tend to think of tertiary students as a privileged group.

The research has now indicated how deep the problem really is on campus. The students that most likely go hungry are single, male, black or coloured, and are generally first-generation students.

They are also mostly undergraduates, those paying their studies from non-bank loans or bursary means, those not living with their parents or guardians or those that need to support somebody else financially.

The results further indicate that those that are likely to suffer from hunger seldom or never have enough money for food but have to borrow money for food, have to ask for food, sell items to get food or steal food.

“A healthy student is a
successful student.”

Bursary money send back home for parents to survive
Dr Van den Berg agrees that one of the main reasons for the situation is economic stress. Research has shown students rarely spend money on food when resources are scarce. Furthermore, parents of students studying with bursaries are not always able to fully support them on campus. Some students send bursary money back home for their parents to survive.

She says other factors that contribute to campus food insecurity are that all over the world universities have terminated catered food halls due to high costs. “To a large extent this has created a food desert for students and now they need to look after themselves.”

To throw money at the problem does not seem to be the answer. 

Students are food-uncertain beings
The research indicates that young people on campus do not know where to buy food, much less the correct, nutritional food they need. Dr Van den Berg says most universities are now aware of the problem and have been taking steps. This includes teaching students how to budget and making them aware how important nutrition is for their success and their responsibility for themselves.

Universities are also looking at private funding for food aid and food schemes. Dr Van den Berg says other solutions are the restructuring of bursary fees, student self-help initiatives and food gardens.

The Faculty of Health Sciences is taking the initiative to manage a food blog on the UFS website. It will also use other social media platforms to post food-preparation videos and recipes for students.

Dr Van den Berg says it is important to grow the 15.6% group of students who indicated they are food secure because a healthy student is a successful student.

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