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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

Historians must place African history on world stage – Dr Zeleza
2017-05-30

 Description: Historians must place African history on world stage Tags: Historians must place African history on world stage

From the left: Panellists Rev Henry Jackson,
Prof Irikidzayi Manase and Arno Van Niekerk at a book
launch and panel discussion on Africa Day hosted by the
UFS Sasol Library.
Photo: Mamosa Makaya

“African historians must take seriously the challenge of placing African history in world history, and in the history of our species, Homo sapiens.”

With these words, Dr Paul Tiyambe Zeleza, Vice Chancellor of the United States International University-Africa in Nairobi, Kenya, stressed the continent’s challenge.

According to him the contest should continue to recover and reconstruct Africa’s long history. Liberating African knowledges can be done by: “Provincialising Europe that has monopolised universality, universalising Africa beyond its Eurocentric provincialisation, and engaging histories of other continents on their own terms.”

University celebrates Africa Month in various ways  
Dr Zeleza delivered the ninth Africa Day Memorial Lecture, titled The Decolonisation of African Knowledges, at the University of the Free State (UFS). The lecture, hosted by the Centre for Africa Studies (CAS), took place on 24 May 2017 in the Equitas Auditorium on the Bloemfontein Campus and was one of the ways in which the UFS celebrated Africa Month.

Scholars should immerse themselves in these thoughts

Dr Zeleza focused on two issues, which he said were interconnected. They were the unfinished project of decolonising African knowledges and the continent's positioning in global knowledge production.

He said Africa’s scholars and students should “immerse themselves in the rich traditions of African social thought going back millennia”. According to him the continent’s research profile still remains weak in global terms.

“It is imperative that the various key stakeholders in African higher education from governments to the general public to parents, and to students, faculty, staff, and administrators in the academic institutions themselves, raise the value proposition of African higher education for 21st century African societies, economies, and polities.”

“Colonialism is associated with injustice
and inequality, but what happens when
our liberators become our oppressors?”

Library celebrates with panel discussion and book launch
The UFS Sasol Library celebrated Africa Day by presenting a book launch and panel discussion on 25 May 2017, on the pertinent and current political theme of land redistribution with a comparative basis of land invasions in Zimbabwe.

Prof Irikidzayi Manase discussed his book White Narratives: The Depiction of Post-2000 Land Invasions in Zimbabwe, accompanied by Rev Henry Jackson who wrote Another Farm in Africa. A perspective of the economic implications of land redistribution in South Africa was discussed by panellist Arno Van Niekerk: Senior Lecturer of Economics at the UFS Faculty of Economic and Management Sciences.

Inequality still an African problem
The content of the books are a stark reminder of the burning issues of inequality and loss of identity of those who lost their farms in Zimbabwe, a collection of memoirs by white farmers and their families. Rev Jackson gave a religious perspective on reconciliation, forgiveness and the question of land ownership, saying that healing of injustice begins with forgiveness of past transgressions.

Van Niekerk highlighted that while land issues were important, “social cohesion is affected by the economic decisions that will be made”. In closing, Prof Manase called for serious consideration of what the future may hold. “Colonialism is associated with injustice and inequality, but what happens when our liberators become our oppressors?” 

The panel discussion was attended by staff and students of the university, and was lit up by robust discussions on possible historical and future solutions to the question of land, decolonisation and political power struggles in Southern Africa and lessons to be learned from Zimbabwe.

UFS celebrates Africa Month (24 May 2017)

 

 

 

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