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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

UFS Council votes on top appointments
2003-11-24

The Council of the University of the Free State (UFS) today voted on the filling of four senior vacancies, including three posts at Vice-Rector level and one at the level of Dean.

The Council voted as follows:
- Prof Magda Fourie will be offered the post of Vice-Rector: Academic Planning
- Dr Ezekiel Moraka will be offered the post of Vice-Rector: Student Affairs
- Prof Teuns Verschoor will be offered the post of Vice-Rector: Academic Operations
- Prof Letticia Moja will be offered the post of Dean: Faculty of Health Sciences

Two of the candidates, Prof Teuns Verschoor and Prof Magda Fourie, are currently acting Vice-Rectors at the UFS. Prof Verschoor is acting Vice-Rector for Student Affairs and Prof Fourie is acting Vice-Rector for Academic Planning. Dr Moraka is currently Dean of Student Affairs at the University of Pretoria (UP). Prof Moja is currently the acting Dean of the Faculty of Health Sciences at the UFS.

According to the Rector and Vice-Chancellor of the UFS, Prof Frederick Fourie, the filling of these senior vacancies comes after one of the most thorough search and selection processes ever at the UFS.

“It is wonderful that we are able to celebrate the outcome of this process that has brought forward such excellent candidates who reflect our country’s diversity. It shows that we can achieve the goals of quality and diversity at the same time,” Prof Fourie said.

Prof Magda Fourie (49) received her Ph D on Institutional governance of higher education in transition: a South African perspective from the UFS in 1996. She joined the UFS in 1998, later becoming Director of the Centre for Higher Education Studies and Development and Professor in Higher Education Studies. She said in her declaration of intent her aspiration is to contribute to making the UFS the excellent university it foresees in its vision and mission. Academic planning should position the UFS with regard to its core activities strategically as an institution of excellence that will meet the future from a strong basis of academic integrity and credibility.

Dr Moraka (45) received his Ph D in Education Management on Management of change and conflict resolution by student affairs officers at historically white universities in South Africa from the UP in 2002. He is Dean of Students at the UP since 2001. Before that he was Head of Student Support and Student Social Services at the UP for six years. He was also, among others, a lecturer at a college of education and a pastor of the Dutch Reformed Church in Africa. He said in his declaration of intent that diversity can become so greatly emphasised that people can be driven further apart. Focus should be on moulding a student community where everyone can feel at home, a community which lives together and works together without destroying what is unique to each individual.

Prof Verschoor (53) received his LL D in 1980 at the University of Pretoria on The criminal responsibility of psychopaths and similar figures. He was professor in and Head of the Department of Criminal Law and Medical Law at the UFS for 17 years before becoming Dean of Students in 1994. He said in his declaration of intent that he dreams of the realisation of projects that are awaiting the enthusiastic support, bringing together and empowering of persons involved by a Vice-Rector that wants to see the UFS prosper in an era of continuing dynamic development. In this he would like to make a substantial contribution.

Prof Moja (46) received her MB ChB in 1982 from the University of Natal and her M.Med in Obstetrics and Gynecology in 1990 from the Medical University of South Africa (Medunsa). She became a full professor in 2003 at the UFS and has been acting as Dean of the UFS’s Faculty of Health Sciences since February 2003. She said in her declaration of intent that the challenge for her is to manage change with the ultimate aim of both achieving the vision of the UFS and satisfying the needs of the community. Some of the academic challenges include the training of more people from designated groups and rural areas. Careful planning and integration of the curriculum should be done to ensure that all students perform to their best.

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