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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

Student leaders reflect on post-Holocaust Germany and make connections to post-apartheid SA in study tour
2015-12-08

Njabulo Mabaso
Photo: Sam Styrax

“Our beloved South Africa (SA) has done quite a lot insofar as policy formulation to address the past imbalances is concerned. However, implementation has proven to be the biggest challenge.”

This is the view held by Nkosinathi Tshabalala, former Student Representative Council (SRC): Religious Affairs at Qwaqwa Campus of the University of the Free State (UFS), who was part of the Global Leadership Study Tour.

From 14 - 22 November 2015, a cohort of 37 outgoing SRC members studied through tours and seminars in Germany and Poland. The historical education trip was organised jointly by UFS Rector and Vice-Chancellor, Prof Jonathan Jansen, and the Student Affairs office. The study tour was supported and facilitated by the Johannesburg Holocaust and Genocide Centre.

Tshabalala added: “We know the thinking behind the likes of Reconstruction and Development Programme and the Truth and Reconciliation Commission, to mention only two. But what have these done to close the gap between the rich and the poor? What have they done to encourage proper and complete reconciliation? Germany paid for the damages which came as a result of the Holocaust, and it is time that we do the same.”

Mosa Leteane, former SRC President of the Bloemfontein Campus, echoed Tshabalala’s sentiments as they relate to the SA experience. “In light of the Rhodes Must Fall movement, one of the things that the youth was looking at were the symbols, what symbols mean, how symbols works as part of reparation and redress in a country that has come from a tragic past,” she said.

Leteane identified similarities between how our country and the two European nations have confronted the issue of trans-generational trauma and the reconciliation process, albeit in significantly differing circumstances.

“Within the first 20 years or so, it was almost like SA. Nobody wanted to talk about it, people just wanted to build the country.” Nonetheless, “the memorialisation and commemoration happened only for the last 20 years or so,” added Leteane.

Transformation of the European political, environmental, and social landscape took place only when students and the second generation began to challenge the status quo, and to lobby for transformation through the erection of memorials and monuments. Owing to the courage of the young generation, those countries were able to take meaningful steps towards transformation through an accurate narration and commemoration of history, which is a key factor in reconciliation.

Our students had the opportunity to conduct a comparative study of post-Holocaust Germany and post-apartheid South Africa in terms of how government and universities dealt with trans-generational trauma.

By being exposed to remnants of what used to be sites such as the Auschwitz-Birkenau concentration camp memorial in Poland, the young leaders were encouraged to continue their attempt at nation building and advance transformation and reconciliation.


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