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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

Stress and fear on wild animals examined
2013-06-04

 

Dr Kate Nowak in the Soutpansberg Mountain
Photo: Supplied
04 June 2013

Have you ever wondered how our wild cousins deal with stress? Dr Kate Nowak, visiting postdoctoral researcher at the Zoology and Entomology Department at the UFS Qwaqwa Campus, has been assigned the task to find out. She is currently conducting research on the effects that stress and fear has on primate cognition.

The Primate and Predator project has been established over the last two years, following Dr Aliza le Roux’s (also at the Zoology and Entomology Department at Qwaqwa) interest in the effects of fear on primate cognition. Dr le Roux collaborates with Dr Russel Hill of Durham University (UK) at the Lajuma Research Centre in Limpopo and Dr Nowak has subsequently been brought in to conduct the study.

Research on humans and captive animals has indicated that stress can powerfully decrease individuals’ cognitive performance. Very little is known about the influence of stress and fear on the cognition of wild animals, though. Dr Nowak will examine the cognition of wild primates during actual risk posed by predators. This is known as the “landscape of fear” in her research.

“I feel very privileged to be living at Lajuma and on top of a mountain in the Soutpansberg Mountain Range. We are surrounded by nature – many different kinds of habitats including a tall mist-belt forest and a variety of wildlife which we see regularly, including samangos, chacma baboons and vervet monkeys, red duiker, rock hyrax, banded mongooses, crowned eagles, crested guinea fowl and cape batis. And of course those we don't see but find signs of, such as leopard, genet, civet and porcupine. Studying the behaviour of wild animals is a very special, and very humbling, experience, reminding us of the diversity of life of which humans are only a very small part,” said Dr Nowak.

At present, the research team is running Giving up Densities (GUD) experiments. This represents the process during which an animal forsakes a patch dense with food to forage at a different spot. The animal faces a trade-off between meeting energy demands and safety – making itself vulnerable to predators such as leopards and eagles. Dr le Roux said that, “researchers from the US and Europe are embracing cognitive ecology, revealing absolutely stunning facts about what animals can and can’t do. Hence, I don’t see why South Africans cannot do the same.”

Dr Nowak received the Claude Leon Fellowship for her project. Her research as a trustee of the foundation will increase the volume and quality of research output at the UFS and enhance the overall culture of research. Her analysis on the effect that stress and fear have on wild primates’ cognition will considerably inform the emerging field of cognitive ecology.

The field of cognitive ecology is relatively new. The term was coined in the 1990s by Les Real to bring together the fields of cognitive science and behavioural ecology.


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