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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 extends footprint abroad
2015-12-14

In its constant pursuit of research excellence, the UFS has this year performed well in mainly two areas.

Apart from the research done by the UFS on national level, e.g. the involvement of its researchers with the SKA telescope, the pioneering work they do with the satellite tracking of giraffes, as well as research on trauma, forgiveness and reconciliation – to name but a few of the research areas, the university also has a research focus abroad.

Japan, Europe, America and Botswana. These are just some of the places where academics from the university are involved in research abroad.

Japan

Dr Dirk Opperman, Senior Lecturer at the Department of Microbial, Biochemical and Food Biotechnology, and Carmien Tolmie, a PhD student in the same department, visited the Okinawa Institute of Science and Technology in Onna, Japan, during November and December 2014. During the visit, experiments were performed in the Microbiology and Biochemistry of Secondary Metabolite Unit of Dr Holger Jenke-Kodama.

This formed part of a larger NRF-funded project on carcinogenic toxins produced in certain Aspergillus fungi. These fungi infect food and feedstuff and are a big concern in developing countries because it may lead to severe economic losses. The research ultimately aims to find inhibitors to block the production of these fungal toxins.



Europe and America

In 2012, an international network was established in the frame of the FP7-PEOPLE-2011-IRSES programme, called hERG-related risk assessment of botanicals (hERGscreen). The South African group included Dr Susan Bonnet and Dr Anke Wilhelm, both from the UFS Department of Chemistry.

Extracts from more than 450 South African plant species have been investigated systematically to assess the potential cardiotoxic risk of commonly consumed botanicals and supplements. The idea of the project, funded by the European Commission, is to identify safety liabilities of botanicals.

Other international partners included the University of Innsbruck, National and Kapodistrian University of Athens, Biomedical Research Foundation of the Academy of Athens, University of Basel, University of Vienna, University of Florida, Universidade Federal do Rio Grande do Sul, Universidade Federal de Santa Catarina.

Botswana


A memorandum of understanding was signed between the UFS and Botho University in Botswana in September 2015, which will be valid for three years.

The agreement, includes student and staff exchange programmes, collaborative research, teaching and learning and community engagement activities, sharing of results, and PhD/ MPhil guidance.

Young researchers

Another research focus of the UFS is the development of its young researchers. In 2015, the UFS has delivered 13 Y-rated researchers. Ten of the researchers are from the Faculty of Natural and Agricultural Sciences and three from the Faculty of the Humanities. Three of them received an Y1 rating from the NRF.

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