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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 becomes the first university in Africa to sign a memorandum of understanding with the United Nations University
2009-12-01

 During the signing of the memorandum of agreement between DiMTEC and the United Nations University in Bonn, Germany were, from the left, seated: Prof. Konrad Osterwalder, Under-Secretary-General of the United Nations and Rector of the United Nations University; and Prof. Herman van Schalkwyk, Dean of the Faculty of Natural and Agricultural Sciences at the UFS; back: Prof. Dusan Sakulski, Academic Officer, UNU Cooperative Unit for South Africa; and Mr Andries Jordaan, Director of DiMTEC at the UFS.
Photo: Supplied
 
The University of the Free State (UFS) has become the first university in Africa to sign a memorandum of understanding with the United Nations University. The memorandum of understanding was negotiated by Mr Andries Jordaan, Director of the UFS's Disaster Management Training and Education Centre for Africa (DiMTEC).

Mr Jordaan negotiated with the United Nations University Institute for Environment and Human Security (UNU-EHS) to foster a relationship and combine their pool of resources for training in different aspects of Disaster Management. A triangular agreement between DiMTEC, UNU-EHS and the University of Novi Sad in Serbia will be established in three phases. The first phase is the signing of a memorandum of understanding between DiMTEC and UNU-EHS. This phase was completed in September 2009, when Prof. Konrad Osterwalder, Under-Secretary-General of the United Nations and Rector of the United Nations University, and Prof. Herman van Schalkwyk, Dean of the Faculty of Natural and Agricultural Sciences at the UFS signed the memorandum in Bonn, Germany. The second phase is a memorandum of understanding between UNU-EHS and the University of Novi Sad.

The memorandum of understanding entails among others joint projects between DiMTEC and the UNU-EHS, research for specific projects, exchange of lecturers and that the UNU will assist DiMTEC with external evaluation. As a result of this memorandum, the two universities have already combined their pool of resources by presenting a vulnerability short course and a visitation to the Republic of the Congo.

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