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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

Professor launches his book, opposition parties attend
2011-03-22

Prof. Hussein Solomon
Photo: Stephen Collett

“We are good in opposing people, but we’re less good in opposing ideas.” This was how Prof. Jonathan Jansen, Vice-Chancellor and Rector of the University of the Free State (UFS) introduced the book launch of Against all Odds: Opposition Politics in Southern Africa.

The event was hosted in collaboration with the publisher under the title: Are opposition parties in South Africa in a crisis? This formed part of a series of dialogue sessions, organised by the Centre for Africa Studies, in the run up to the local elections.
 
Amongst those interested who attended the evening in the Senate Hall of the CR Swart Building on the Main Campus were various politicians, students, staff en a panel consisting of academics and the respective provincial representatives of the ANC and DA.
 
Dr Mcebisi Ndletyana from the Human Sciences Research Council (HSRC), acted as arbiter.
 
Proff. Hussein Solomon, author of Against all Odds: Opposition Politics in Southern Africa, also lecturer at the UFS, as well as Dirk Kotzé, Head of the Department of Political Science at Unisa, delivered enriching lectures on the stance and positioning of opposition parties.
 
Prof. Hussein, who spoke first, circumscribed the context of the political climate in the country, based on his book. “The problem that political science encounters is that everybody becomes experts on the internet, while they have no experience of what is happening in South Africa.” He said that when political parties in the country are under discussion, voters often allow myths and/or stereotyping to influence their concept of it. ‘’If there are no opposition parties, there is no democracy and people are deprived of their vote.”
 
Prof. Kotzé stated in his speech that it was not only opposition parties who had to make the government watch its step, but also the status that the country acquired, amongst others, from its connections, i.e. collaborative agreements such as BRICSA and the country’s inclusion in the G20. He left the audience with a question about how they were going to become involved in politics, and with his rhetoric question referred to options like social networks and movements.
 
Mr Sibongile Besani, the ANC'S secretary in the Free State, said the DA grew due to it’s swallowing of other parties; something he claims is taking the country backwards. He also described the use of personalities by opposition parties as means of association a weakness. He added that voters will continue voting for the ANC because they can associate themselves with the party’s vision.
 
In contrast, Mr Roy Jankielsohn, provincial leader of the DA, said voters and parties unite under their core vision for the country as like in the case of the ANC during the liberation struggles.
 
During the question-and-answer session, which followed after Mr Jankielson’s speech, Prof. Kwandiwe Kondlo, upon completion and summary of the discussions, stated firmly that the opposition parties are in a crisis. “The start of the solution is to recognise the problem. That is why our democracy finds itself in the state in which it is; because the opposition does not fulfil the role that they are supposed to fulfil.“ Prof. Kondlo is the head of the Centre of Africa Studies at the UFS.
 
He concluded by stating that the economic basis in the country was not transformed. “We cannot say that people determine their futures if they posses nothing. Opposition parties must start to communicate at this level in order to table something new. Our democracy must become more inclusive at political and material level.”

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