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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 academic joins an elite league of achievers
2010-04-14

Prof. Dingie van Rensburg, Director of the Centre for Health Systems Research  Development at the University of the Free State
Prof. Dingie van Rensburg
Prof. Dingie van Rensburg, Director of the Centre for Health Systems Research & Development at the University of the Free State (UFS), has joined an elite list of a only few distinguished individuals who have been awarded honorary doctorates by the University of Antwerp (UA) in Belgium.

He is only the third South African to be honoured in this way by the UA, following in the footsteps of Constitutional Court Judge Albie Sachs (2000) and former State President, Nelson Mandela (2004).

He is the first social scientist from South Africa to receive this honorary doctorate from the UA – the highest academic distinction of that university. The university has previously only awarded three honorary doctorates to social scientists: Prof. Raymond Boudon, sociologist at the University of Paris-Sorbonne (1995); Prof. Robert Putman, political scientist at Harvard University (2000); and Prof. John Nash (of A Beautiful Mind fame), mathematician and economist at Massachusetts Institute of Technology (MIT) and Princeton.

The award ceremony will take place on 29 April 2010 in Antwerp.

Prof. Van Rensburg has authored, co-authored and was editor of many books/volumes, chapters in books, monographs, research reports and articles in scientific journals. He has also presented and co-presented at numerous national and international conferences; and supervised a significant number of master’s, doctoral and post-doctoral students.

In his 17 years as director of the Centre he has initiated, managed and led approximately 50 research and development projects, several of them large and long-term projects, and many of an inter-institutional and multidisciplinary nature.

In 2002 he became an NRF-rated researcher and in 2007 his rating as an established researcher was renewed. In the past two decades he received several research grants simultaneously from both the National Research Foundation and the Medical Research Foundation of South Africa, mostly for projects on Tuberculosis, HIV/Aids and antiretroviral treatment.

Prof Van Rensburg holds membership of both the Suid-Afrikaanse Akademie vir Wetenskap en Kuns and the Academy for Science of South Africa; he also served for varying periods on the Councils of both these academies. He was also a member of various health bodies of the Free State Province and the National Science and Technology Forum.

Media Release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt@ufs.ac.za  
14 April 2010
 

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