Latest News Archive

Please select Category, Year, and then Month to display items
Categories
UFS News Media Release Research
Years
2017 2018 2019 2020 2021 2022 2023 2024
Months
January February March April May June July August September October November December
Previous Archive
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

‘Is the South African university curriculum ‘colonial'?’ asks Prof Jansen
2017-11-24

Description: Jansen readmore Tags: Prof Jonathan Jansen, colonial, university curriculum, western knowledge

From left; Prof Corli Witthuhn, Vice-Rector: Research; former Rector and Vice-
Chancellor of the UFS, Prof Jonathan Jansen; Prof Michael Levitt, and
Prof Francis Petersen at the celebration lecture at the UFS.
Photo: Johan Roux

One of the critical issues that emerged from the South African student protests during 2015 and 2016 was a demand for the decolonisation of university curriculums. 

A senior professor at the Stellenbosch University, Prof Jonathan Jansen, said the number of people, including academics, who joined the cause without adequately interrogating the language of this protest, was astonishing. “The role of social scientists is to investigate new ideas … when something is presented to the world as truth.” Prof Jansen was speaking during a celebration lecture at the University of the Free State in Bloemfontein on 15 November 2017. 

Large amount of knowledge not African
He said the accusation is correct to a limited degree. “The objection, in essence, is against the centring of Western, and especially European knowledge, in institutional curricula.” There is no doubt that most of what constitutes curriculum knowledge in South African universities, and in universities around the world, derive from the West. “The major theories and theorists, the methodologists and methods are disproportionally situated outside of the developing world,” Prof Jansen said. 

The dilemma is, how will South Africa and the continent change the locus of knowledge production, considering the deteriorating state of public universities? “In the absence of vibrant, original, and creative knowledge production systems in Africa and South Africa, where will this African-centred or African-led curriculum theory come from,” Jansen asked. He says the re-centring of a curriculum needs scholars with significant post-doctoral experiences that are rooted in the study of education and endowed with the critical independence of thought. “South Africa's universities are not places where scholars can think. South African universities’ current primary occupation is security and police dogs,” Prof Jansen said. 

Collaboration between African and Western scholars
“Despite the challenges, not everything was stuck in the past,” Prof Jansen said. South African scholars now lead major research programmes in the country intellectually. The common thread between these projects is that the content is African in the subjects of study, and the work reflects collaboration with academics in the rest of the world. These research projects attract postgraduate students from the West, and the research increasingly affects curriculum transformations across university departments. There is also an ongoing shift in the locus of authority for knowledge production within leading universities in South Africa. Prof Jansen feels a significant problem that is being ignored in the curriculum debate, is the concern about the knowledge of the future. How does South Africa prepare its young for the opportunities provided by the groundswell of technological innovation? “In other parts of the world, school children are learning coding, artificial intelligence, and automation on a large scale. They are introduced to neuroscience and applied mathematics,” he said.

Prof Jansen said, in contrast, in South Africa the debate focuses on the merits of mathematics literacy, and what to do with dead people’s statues.

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept