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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

"Service" needs to return to public service
2010-09-14

At the memorial lecture were, from the left, front: Chris Hendriks, Proff. Liezel Lues, Chris Thornhill and Lyndon du Plessis; middle: Prof. Hendri Kroukamp, Mss Alet Fouche, Lizette Pretorius; and back: Proff. Koos Bekker and Moses Sindane.
– Photo: Stephen Collett.

There is a serious need for the concept of “service” to be reintroduced to the public service. In addition to this, public servants need to behave ethically and honestly if the public service were to achieve its main aim of service delivery to South African citizens and thereby also restore the trust of citizens in the state.

This was the central theme of the JN Boshoff Commemorative Lecture hosted by the Department of Public Administration and Management at the University of the Free State UFS). The lecture by Prof. Chris Thornhill, emeritus professor of Public Administration and Management at the University of Pretoria, focused on “Administrative and Governmental Challenges: Lessons from the Past”. He drew pertinent parallels with the administrative and governmental practices during the times of Pres. JN Boshoff, second president of the Orange Free State in 1855, and the challenges faced in this regard by the current government and public service.

Prof. Thornhill highlighted important aspects such as globalisation, the environment, public service and democratic government in his presentation.
He said the borders between countries have all but vanished and governments therefore have to carefully consider the effects of globalisation on its domestic affairs. The strength of a country’s currency, for example, was not only determined by how that country viewed or perceived it, but also by the international community’s perception of that country’s political and economic stability. This, in turn, could have serious implications for that country’s investment and economic prospects.

Governments are compelled to attend to the utilisation of its natural resources as these resources are finite and therefore irreplaceable. Policy interventions have to be introduced to decrease or regulate the use of certain natural resources or alternative measures need to be introduced. The example of bio-fuel production in various countries was highlighted.

He said the South African public service is characterised by three debilitating factors, namely the prevalence of corruption, the interference of politicians in administrative functions and a lack of appropriate skills and therefore a lack of commitment on the part of officials. In the municipal sector, for example, 46% of municipal managers have less than one year’s experience and this mainly occurs because of the practice of deployment (the appointment of a person based on political affiliation). An amendment to the Local Government: Municipal Systems Act is currently under consideration, in terms of which municipal managers will be disallowed to hold party political positions simultaneously.

According to Prof. Thornhill this is a step in the right direction, but more needs to be done to neutralise the impact of these debilitating factors in order to restore the credibility of the public service.

On democratic government Prof. Thornhill said the fact that the majority of a country’s citizens elect a political party to power does not automatically make the government capable of governing effectively and efficiently. It is therefore important for the rulers to understand their governing role within a democratic context, but more importantly to act accordingly. It is also important not to centralise power unduly as this could be a serious threat to accountable government. The 17th amendment to the Constitution, 1996, currently under consideration, and in terms of which national and provincial government will be allowed to intervene in local government matters, was highlighted as a case in point.

Prof. Thornhill said it was essential for those involved to sincerely and honestly and ethically deal with the above matters for the public service to overcome current challenges.
 

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