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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

UFS hosts first ACS Institute held on African soil
2015-12-08



The first ever Association for Cultural Studies (ACS) Institute hosted on the African continent is taking place on the Bloemfontein Campus. At the event are, from the left: Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS; Prof Jean Comaroff, Alfred North Whitehead Professor of African and African-American Studies and Anthropology at Harvard University; Prof Helene Strauss, Chair of the Department of English at the UFS; and Prof Gil Rodman, Chair of the Association for Cultural Studies and Professor of Communication Studies at the University of Minnesota.
Photo: Johan Roux

The University of the Free State (UFS) is hosting the 2015 conference of the Association for Cultural Studies (ACS) Institute – the first time for this international event to take place on the African continent.

From 7 – 12 December 2015, some of the world’s leading scholars in cultural studies are taking part in the conference on the Bloemfontein Campus. The event has been organised by the UFS Department of English in collaboration with colleagues from other departments in the Faculty of the Humanities.

 The ACS is the foremost international association for scholars in cultural studies, and has been hosting the biennial Crossroads in Cultural Studies Conference since 2006. In 2011, the ACS held its inaugural institute at the University of Ghent (Belgium), followed, in 2013, by one at the Alpen-Adria University Klagenfurt (Austria). As the 2015 meeting of the institute is the first to be held in Africa, the organisers aim at highlighting the contributions that scholars from our continent and other (post)colonial contexts have made to cultural studies, even as it engaged many of the long-standing theoretical concerns generated for the field by scholars from the Global North.

Themed ‘Precarious Futures’, the conference explores how cultural studies might assist in charting more equitable futures by reflecting critically on the cultural, economic, and political trajectories within which precariousness – a state increasingly anticipated for the planet – might be altered. Experts in a diversity of disciplines are sharing their perspectives in the form of seminars and lectures.

Keynote lectures are delivered by Prof Jean Comaroff (Harvard University), Prof John Erni (Hong Kong Baptist University), Dr Jo Littler (City University London), Dr Zethu Matebeni (University of Cape Town), and Prof Handel Kashope Wright (University of British Columbia).

In her opening lecture on Monday 7 December 2015, Prof Comaroff addressed the challenging relationship of law, detection, and sovereignty in contemporary African polities within the South African post-apartheid context.

Topics discussed include climate change; the archives of everyday life; cross-racial intimacies; ethnography; meritocracy; cultural studies and human rights; China and globalisation; gender, sexuality, and race; and governance, embodiment and the work of care.

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