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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

Mellon Foundation awards R10 million research grant to Trauma, Forgiveness and Reconciliation Studies
2015-02-20

Prof Pumla Gobodo-Madikizela, Senior Research Professor in Trauma, Forgiveness and Reconciliation Studies, and Dr Saleem Badat, Programme Director at the Mellon Foundation.
Photo: Johan Roux

Through her profound insight, vast experience, and unfaltering belief in humanity, Prof Pumla Gobodo-Madikizela, has secured a R10 million grant from one of the world’s most prestigious foundations funding human sciences research.

“This is one of the biggest grants that the Andrew W. Mellon Foundation has awarded to a university”, said Dr Saleem Badat, Program Director: International Higher Education and Strategic Projects at the Mellon Foundation. Prof Badat attended the press event that took place on 16 February 2015 on our Bloemfontein Campus.

UFS Trauma, Forgiveness, and Reconciliation Studies, spearheaded by Prof Gobodo-Madikizela, will manage the research project.

Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS, expressed great excitement “about this particular grant and the subject on which it focuses is so incredibly timely and germane to our own situation.”

Trauma, Memory and Representations of the Past: Transforming Scholarship in the Humanities and Arts

This new-found partnership between the Mellon Foundation and the UFS will enable a five-year research programme. The focus area of this initiative will be ‘Trauma, Memory and Representations of the Past: Transforming Scholarship in the Humanities and Arts’.

The research will pivot specifically around the question of how trauma is transmitted from one generation to the next. “South Africa lends itself to these questions,” Prof Gobodo-Madikizela said, “because we are now dealing with a generation of young people who were born after the traumas of the past.” These past experiences, though, are “passed on to the younger generation and become their own stories and narratives as if they themselves experienced the traumas directly.”

“This is an investment in how we can in fact create a different kind of community,” Prof Jansen said, “in which we eventually recognise each other – not by the accident of our skin, but by that elusive sense of a common humanity.”

Arts and theatre

Other aspects critical to this study are the inclusion of the arts and theatre. Many people have great difficulty in expressing their experiences of trauma in the spoken word. The arts and theatre provide an ideal platform to engage the public and stimulate conversation. As an example of the power these platforms possess, Prof Gobodo-Madikizela highlighted the success of the Johannes Stegmann Art Gallery – situated on the Bloemfontein Campus and curated by Angela de Jesus – in engaging the public in very productive ways.

Participants

Some of the artists, directors and scholars who will join in this project include:

• Lara Foot-Newton, Director/Playwright
• Sue Williamson, Activist Artist
• Angela de Jesus, Visual Artist/Curator
• Dr Buhle Zuma, Social Psychology Research
• Dr Shose Khessi, Social Psychology Research
• Prof Tamara Shefer, Women’s and Gender Studies
• Prof Kopano Ratele, Gender/Men and Masculinities
• Prof Jan Coetzee, Sociology of Developing Societies
• Prof Helene Strauss, Literary and Cultural Studies

New intellectual frontiers

“There is an aspiration in this proposal,” Dr Saleem Badat said. “We were born through this pain of colonialism and apartheid; we even went through the TRC. Our scholars in this country, our universities, should be at the forefront of this research. This is not research we can leave to the institutions in the north.”

Prof Gobodo-Madikizela agreed. “The overarching theme of this work is new knowledge production, focusing on the experiences in South Africa as experiences that can teach us something new.”

This will serve not only South Africa, but can also establish support for, and inform, countries facing similar dilemmas. In fact, “any part of the world in which genocide and murder and racism remains as legacies from the past,” Dr Badat said.

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