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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

Moshoeshoe - lessons from an African icon - by Prof Frederick Fourie
2004-11-03

(The full text of the article that appeared in City Press and Sunday Independent)

Our understanding of history informs our understanding of the present. No wonder the contestation over historical figures in South Africa’s past is so fierce and so divisive.
The question is: could it be any other way? I would like to think that it could; that black and white South Africans, across linguistic, cultural, religious and other divides, can develop a shared appreciation of our history – at least with certain periods and personalities as a starting point.

One such personality whose legacy I believe offers a possible platform for unifying our still divided country is King Moshoeshoe, who lived from 1786 to 1870, and is acknowledged as the founder of the Basotho.

King Moshoeshoe is the topic of a documentary that has been commissioned by the University of the Free State as part of its Centenary celebrations this year. It is part of a larger project to honour and research the legacy of Moshoeshoe. The documentary will be screened on SABC 2 at 21:00 on November 4th.

Moshoeshoe rose to prominence at a time of great upheaval and conflict in South Africa – the 19th century, a time when British colonialism was entrenching itself, when the Boer trekkers were migrating from the Cape and when numerous indigenous chiefdoms and groupings were engaged in territorial conquests. It was the time of the Difaqane, a period when society in the central parts of the later South Africa and Lesotho was fractured, destabilised and caught in a cycle of violence and aggression.

In this period Moshoeshoe displayed a unique and innovative model of leadership that resulted in reconciliation, peace and stability in the area that later became Lesotho and Free State. It made him stand out from many of his contemporaries and also caught the attention of his colonial adversaries.

Such an evaluation is not a judgment about which model of leadership is right and which is wrong, or which leader was better than another; but merely an attempt to explore what we can learn from a particular exemplar.
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Historians point to the many progressive leadership qualities displayed by Moshoeshoe which he used effectively in establishing the Basotho nation and in defending it.
First, there is his humanism and sense of justice worthy of any great statesman. Confronted by a situation in which cannibals murdered and devoured his grandfather, Moshoeshoe chose not to take revenge. Instead he opted to rehabilitate them and feed them as he believed hunger drove them to cannibalism.

Secondly, there is his skilful alliance-building with his contemporaries such as Shaka in an attempt to neutralize those rivals who were intent on attacking his followers. This is also displayed in the way he sought the protection of the British to keep the Boer forces at bay.
Thirdly, his emphasis on peaceful options is also seen in his defensive military strategy which saw him retreat to a mountain fortress to be able to protect and build a burgeoning nation in the face of the many forces threatening its survival.

Fourthly, there is his remarkable inclusivity and tolerance for diversity which saw him unite disparate groups of refugees from the violence and hunger that displaced them and then weld them into the Basotho nation. He also engaged with French missionaries, inviting them to stay with him and advise him on Western thought, technology and religion.
These are but some of the qualities which belie the notion that all 19th century African leaders were merely marauders and conquerors that gained their ascendancy through violence. Instead Moshoeshoe is a prime example of the human-centred, democratic and pluralist roots of South African, indeed African society.

The Moshoeshoe project that we have initiated (of which the documentary, called “The Renaissance King”, forms but one part) derives from our location as a university in the Free State, a province with a particular history and a particular political culture that developed as a result of this very model of leadership. This province has benefited tremendously from leaders such as Moshoeshoe and president MT Steyn, both of whom many observers credit with establishing a climate of tolerance, respect for diversity of opinion, political accommodation and peaceful methods of pursuing political objectives in the province. Their legacy is real – and Moshoeshoe’s role can not be overstated.
In addition the project derives from the University of the Free State being a site of higher learning in a broader geo-political sense. As a university in Africa we are called upon to understand and critically engage with this history, this context and this legacy.
Besides the documentary, the UFS is also planning to establish an annual Moshoeshoe memorial lecture which will focus on and interrogate models of African leadership, nation-building, reconciliation, diversity management and political tolerance.

In tackling such projects, there may be a temptation to engage in myth-making. It is a trap we must be wary of, especially as an institution of higher learning. We need to ask critical questions about some aspects of Moshoeshoe’s leadership but of current political leadership as well. Thus there is a need for rigorous academic research into aspects of the Moshoeshoe legacy in particular but also into these above-mentioned issues.
While the documentary was commissioned to coincide with the University of the Free State’s centenary and our country’s ten years of democracy, it is a project that has a much wider significance. It is an attempt to get people talking about our past and about our future, as a campus, as a province and as a country – even as a continent, given the NEPAD initiatives to promote democracy and good governance.

The project therefore has particular relevance for the continued transformation of institutions such as universities and the transformation of our society. Hopefully it will assist those who are confronted by the question how to bring about new institutional cultures or even a national political culture that is truly inclusive, tolerant, democratic, non-sexist, non-racial, multilingual and multicultural.

I believe that the Moshoeshoe model of leadership can be emulated and provide some point of convergence. A fractured society such as ours needs points of convergence, icons and heroes which we can share. Moshoeshoe is one such an African icon – in a world with too few of them.

Prof Frederick Fourie is the Rector and Vice-Chancellor of the University of the Free State

* The documentary on “Moshoeshoe: The Renaissance King” will be screened on SABC2 on 4 November 2004 at 21:00.

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