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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

'Structures of Dominion and Democracy' by David Goldblatt at the Johannes Stegmann Art Gallery
2015-08-03

Photograph by David Goldblatt, On August 16 2012 South African Police shot striking mineworkers of the Lonmin platinum mines, killing 34 and wounding 78 within a radius of 350 metres of this koppie, where the men used to meet. Seventeen of the men, seeking shelter among boulders from police fire, were shot with seemingly lethal intent, some with their hands up in surrender, none were given medical assistance for their wounds. Beyond is the Lonmin smelter, which stood idle during the strike. Marikana, North-West Province, 11 May 2014.

The University of the Free State, in partnership with the Goodman Gallery, presents the exhibition, 'Structures of Dominion and Democracy', by renowned South African photographer David Goldblatt.  

This exhibition, which runs from 13 July to 7 August 2015 on the Bloemfontein Campus, is dedicated to the series, “Structures”, one of the major bodies of works by Goldblatt.  For over three decades, Goldblatt has travelled South Africa, photographing sites and structures weighted with historical narrative: monuments, private, religious and secular, which reveal something about the people who built them.  These sites allow us a glimpse into the everyday. Each place is a repository, a landscape containing an epic story that has involved whole communities: the experience sometimes told through the memorialising of remarkable individuals.

The exhibition, Structures of Dominion and Democracy, traverses two distinct eras in South Africa history. As Goldblatt explains: "Over the years, I have photographed South African structures, which I found eloquent, of the dominion which Whites gradually came to exert over all of South Africa and its peoples.  That time of domination began in 1660 when Jan van Riebeeck ordered a cordon to be erected of blockhouses and barriers that would exclude the indigenous population from access to the first European settlement in South Africa and its herds, lands, water, and grazing.  The time of domination ended on the 2nd of February 1990, when, on behalf of the government and the Whites of South Africa, President FW de Klerk effectively abdicated from power.  Beginning in 1999 and continuing to the present, I have photographed some structures that are eloquent of our still nascent democracy.  In the belief that, in what we build we express much about what we value, I have looked at South African structures as declarations of our value systems, our ethos.”

Johannes Stegmann Art Gallery, UFS Sasol Library
University of the Free State
206 Nelson Mandela Ave
Bloemfontein

Gallery hours:  
Monday to Friday 08:30 – 16:30

Entrance: Free
Enquiries: 051 401 2706, dejesusav@ufs.ac.za

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