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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

Course on sustainable development recognised at COP 17
2011-12-07

 

Some participants of the PED Nexus Programme during a field trip are from left: Jacques van Zuydam, Chief Director: Population and Development at the national  Department of Social Development; Prof. André Pelser, course coordinator (UFS); Prof. Sosten Chiotha, Director, LEAD Southern and Eastern Africa; and Dr Nola Redelinghuys, course facilitator (UFS).

The University of the Free State (UFS) received a nod of approval at the COP 17 Climate Change Conference in Durban for a short course it presents in partnership with the Chief Directorate Population and Development, United Nations Populations Fund (UNFPA), LEAD International and SANParks.

The UFS received an honourable mention in a press release from the Department of Social Development for the short course entitled ‘Leadership Training in Sustainable Development: The Population, Environment and Development (PED) Nexus’. The release was issued as part of COP17. It mentions that the course is recognised in a publication of the United Nations Development Programme (UNDP) as one of ten innovative experiences and best practices in population and development in the developing world.
 
Prof. André Pelser, UFS Professor in Sociology, says the university played a key role in the development and implementation of the course. The UFS has been presenting the course since its inception in 2005.   Similar courses under the banner of the PED Nexus, although in a totally different format, are also presented at the Nelson Mandela Metropolitan University and the University of Cape Town. A total of 21 courses have been presented nationwide since 2005, of which the UFS has hosted eight. More than 230 participants from all over the world have been trained in these eight short nine-day courses.
 
The PED Nexus Programme focuses on the interrelationships of population, environment and development and its significance for sustainable human development and is closely linked to the implementation of the national Population Policy for South Africa. The press release reads that the programme is implemented in the form of short courses that target professionals and managers in governments at all levels as well as non-governmental agencies responsible for the implementation of programmes related to sustainable development.
 
Prof. Pelser and Dr Nola Redelinghuys, also from the Department of Sociology, have recently been tasked by the National Department of Social Development to upgrade the course outline.  The next course will run from 17-25 April 2012. As in the case of pervious courses, the first six days will be hosted on our main Campus in Bloemfontein, whereafter course participants and their facilitators depart to the Golden Gate Highlands National Park for the practical part of the course. 

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