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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

SA universities are becoming the battlegrounds for political gain
2010-11-02

Prof. Kalie Strydom.

No worthwhile contribution can be made to higher education excellence if you do not understand and acknowledge the devastating, but unfortunately unavoidable role of party politics in the system and universities of higher education and training (HET).

This statement was made by Prof. Kalie Strydom during his valedictory lecture made on the Main Campus of the University of the Free State (UFS) in Bloemfontein recently.

Prof. Strydom, who was awarded an Honorary Doctorate by the UFS in 2010, presented a lecture on the theme: The Long Walk to Higher Education and Training Excellence: The Struggle of Comrades and Racists. He provided perspectives on politics in higher education and training (HET) and shared different examples explaining the meaning of excellence in HET in relation to politics.

“At the HET systems level I was fortunate to participate in the deliberations in the early nineties to prepare policy perspectives that could be used by the ANC in HET policy making after the 1994 elections.  At these deliberations one of the important issues discussed was the typical educational and training pyramid recognised in many countries, to establish and maintain successful education and training. The educational pyramid in successful countries was compared to the SA “inverted” pyramid that had already originated during apartheid for all races, but unfortunately exploded during the 16 years of democracy to a dangerous situation of 3 million out-of school and post-school youth with very few education and training opportunities,” he said.

In his lecture, Prof. Strydom answered questions like: Why could we as higher educationists not persuade the new democratically elected government to create a successful education and training pyramid with a strong intermediate college sector in the nineties?  What was the politics like in the early and late nineties about disallowing the acceptance of the successful pyramid of education and training?  Why do we only now in the latest DHET strategic planning 2010–2015 have this successful pyramid as a basis for policymaking and planning?

At an institutional level he explained the role of politics by referring to the Reitz incident at the UFS and the infamous Soudien report on racism in higher education in South Africa highlighting explosive racial situations in our universities and the country.  “To understand this situation we need to acknowledge that we are battling with complex biases influencing the racial situation,” he said.

“White and black, staff and students at our universities are constantly battling with the legacy of the past which is being used, abused and conveniently forgotten, as well as critical events that white and black experience every day of their lives, feeding polarisation of extreme views while eroding common ground.  Examples vary from the indoctrination and prejudice that is continued within most homes, churches and schools; mass media full of murder, rape, corruption; political parties skewing difficult issues for indiscrete political gain; to frustrating non-delivery in almost all spheres of life which frustrates and irritates everyone, all feeding racial stereo typing and prejudice,” said Prof. Strydom.

A South African philosopher, Prof. Willie Esterhuyse, recently used the metaphor of an “Elephant in our lounge” to describe the syndrome of racism that is part of the lives of white and black South Africans in very different ways. He indicated that all of us are aware of the elephant, but we choose not to talk about it, an attitude described by Ruth Frankenberg as ‘colour evasiveness’, which denies the nature and scope of the problem.

Constructs related to race are so contentious that most stakeholders and role-players are unwilling to confront the meanings that they assign to very prominent dimensions of their experience; neither does management at the institutions have enough staff (higher educationists?) with the competencies to interrogate these meanings, or generate shared meanings amongst staff and students (common ground).  A good example that could be compared with “the elephant in our lounge” remark is the recent paper of Prof. Jonathan Jansen, Rector and Vice-Chancellor of the UFS on race categorisation in education and training.

According to Prof. Strydom, universities in South Africa are increasingly becoming the battlegrounds for political gain which creates a polarised atmosphere on campuses and crowds out the moderate middle ground, thereby subverting the role and function of the university as an institution within a specific context, interpreted globally and locally. 

Striving for excellence, mostly free from the negative influences of politics, in HET, from the point of view of the higher educationist, is that we should, through comparative literature review and research, re-conceptualise the university as an institution in a specific context.  This entails carefully considering environment and the positioning of the university leading to a specific institutional culture and recognising the fact that institutional cultures are complicated by many subcultures in academe (faculties) and student life (residences/new generations of commuter students).

Another way forward in striving for excellence, mostly free from politics, is to ensure that we understand the complexities of governing a university better.  D.W. Leslie (2003) mentions formidable tasks related to governance influenced by politics:

  • Balancing legitimacy and effectiveness.
  • Leading along two dimensions: getting work done and engaging people.
  • Differentiating between formal university structures and the functions of universities as they adapt and evolve.
  • Bridging the divergence between cultural and operational imperatives of the bureaucratic and professional sides of the university.

Prof. Strydom concluded by stating that it is possible to continue with an almost never ending list of important themes in HE studies adding perspectives on why it is so easy to misuse universities for politics instead of recognising our responsibility to carefully consider contributions to transformation in such an immensely complicated institution as the university within a higher education and training system. 

Media Release
Issued by: Lacea Loader
Director: Strategic Communication (acting)
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl@ufs.ac.za
29 October 2010

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