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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

Council votes on appointment of senior staff
2004-11-18

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

The Council voted as follows:

Dr Natie Luyt will be offered the post of Dean: Student Affairs Prof Engela Pretorius will be offered the post of Vice-Dean: Faculty of Humanities Dr Choice Makhetha will be offered the post of Vice-Dean: Student Affairs

“There are special challenges for the UFS in the short and medium term regarding transformation of our residences, and a certain combination of management qualities and skills is desirable. As a result of the diversity of the UFS’s student community it is therefore important to us to follow a team approach to deal with the challenges. With the combination of Drs Luyt and Makhetha, I believe we will be able to manage student affairs effectively and skillfully,” says Prof Frederick Fourie, Rector and Vice-Chancellor of 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,” says Prof Fourie.

Prof Pretorius obtained all her qualifications (BA, BA (Hons) (cum laude), MA (cum laude) and D Phil) from the UFS, except for the Certificate in Gender Policy Management (cum laude) which she obtained in 2000 from WITS. She joined the Department of Sociology at UFS in 1980 and has headed the Department since 2001. She acted as Vice-Dean: Faculty of Humanities since July 2004. She has some thirty publications to her credit, published both nationally and internationally and has delivered 20 national and international papers. She is a member of the South African Sociological Association and is a member of the Council of the association and of the Editorial Board of Society in Transition, the society’s journal. She is also a member of the South African Academy for Science and Art and the Federation of African Women Educationalists in South Africa (FAWESA). Project involvement includes the Australian Women’s Executive Development Programme and the project Executive Development of Senior Women in South African Higher Education Institutions. She is also an NRF panelist.

Dr Luyt obtained his qualifications (BA, BA (Hons) (cum laude), MA (cum laude) and D Phil) at the UFS and started his career at the same institution in 1980 as lecturer in Political Science. He was promoted to senior lecturer in 1983 and appointed as Director: Student Affairs in 1997. He has been acting as Dean: Student Affairs since 2003. Dr Luyt completed several work-related training courses, among others a course in ethnic and multiculturality at the Swiss Institute for Federalism and a course in conflict management at the South Tyrolean Economic and Social Institute.

Dr Makheta also obtained all her qualifications (BA, BA (Hons), MA in Political Science and Ph D in Political Science) at the UFS and started working as a student assistant in Political Science at the same institution in 1999. She was promoted to junior assistant in 2000, coordinator and facilitator of Political Science in 2001, assistant/acting Director: Student Affairs in 2001 and acting Director: Student Affairs in 2003. Dr Makhetha is currently a Senior Political Analyst at the Department of Foreign Affairs.

The UFS Council also approved the promotion of nine professors to the rank of senior professor. They are Proff Louise Cilliers (Department English and Classical Languages), Dap Louw (Department of Psychology), Philip Nel (Department Afro-Asiatic Studies, Sign Language and Language Practice), Dirk van den Berg (Department of History of Art and Visual Culture Studies) Dingie van Rensburg (Director: Centre for Health Systems Research and Develoment), Andries Raath (Department of Constitutional Law and Philosophy of Law), James du Preez (Department of Microbial, Biochemical and Food Biotechnology), Johan Grobbelaar (Department of Plant Sciences) and Louis Scott (Department of Plant Sciences).

This is the first group ever of senior professors at the UFS. The post level was created to provide better career and earnings opportunities for high quality academics and to increase the attractiveness of an academic career to young people.

Media release
Issued by: Lacea Loader
Media Representative
Tel: (051) 401-2584
Cell: 083 645 2454
E-mail: loaderl.stg@mail.uovs.ac.za
 

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