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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

NRF researcher addresses racial debates in classrooms
2017-03-24

Description: Dr Marthinus Conradie Tags: Dr Marthinus Conradie

Dr Marthinus Conradie, senior lecturer in the
Department of English, is one of 31 newly-rated National
Research Foundation researchers at the University of
the Free State.
Photo: Rulanzen Martin

Exploring numerous norms and assumptions that impede the investigation of racism and racial inequalities in university classrooms, was central to the scope of the research conducted by Dr Marthinus Conradie, a newly Y-rated National Research Foundation (NRF) researcher.

Support from various colleagues
He is one of 31 newly-rated researchers at the University of the Free State (UFS) and joins the 150 plus researchers at the university who have been rated by the NRF. Dr Conradie specialises in sociolinguistics and cultural studies in the UFS Department of English. “Most of the publications that earned the NRF rating are aimed to contributing a critical race theoretic angle to longstanding debates about how questions surrounding race and racism are raised in classroom contexts,” he said.

Dr Conradie says he is grateful for the support from his colleagues in the Department of English, as well as other members of the Faculty of the Humanities. “Although the NRF rating is assigned to a single person, it is undoubtedly the result of support from a wide range of colleagues, including co-authors Dr Susan Brokensha, Prof Angelique van Niekerk, and Dr Mariza Brooks, as well as our Head of Department, Prof Helene Strauss,” he said.

Should debate be free of emotion?
His ongoing research has not been assigned a title yet, as he and his co-author does not assign titles prior to drafting the final manuscript. “Most, but not all, of the publications included in my application to the NRF draw from discourse analysis of a Foucauldian branch, including discursive psychology,” Dr Conradie says. His research aims to suggest directions and methods for exploring issues about race, racism, and racial equality relating to classroom debates. One thread of this body of work deals with the assumption that classroom debates must exclude emotions. Squandering opportunities to investigate the nature and sources of the emotions provoked by critical literature, might obstruct the discussion of personal histories and experiences of discrimination. “Equally, the demand that educators should control conversations to avoid discomfort might prevent in-depth treatment of broader, structural inequalities that go beyond individual prejudice,” Dr Conradie said. A second stream of research speaks to media representations and cultural capital in advertising discourse. A key example examines the way art from European and American origins are used to imbue commercial brands with connotations of excellence and exclusivity, while references to Africa serve to invoke colonial images of unspoiled landscapes.

A hope to inspire further research
Dr Conradie is hopeful that fellow academics will refine and/or alter the methods he employed, and that they will expand, reinterpret, and challenge his findings with increasing relevance to contemporary concerns, such as the drive towards decolonisation. “When I initially launched the research project (with significant aid from highly accomplished co-authors), the catalogue of existing scholarly works lacked investigations along the particular avenues I aimed to address.”

Dr Conradie said that his future research projects will be shaped by the scholarly and wider social influences he looks to as signposts and from which he hopes to gain guidelines about specific issues in the South African society to which he can make a fruitful contribution.

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