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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 receives multimillion rand international funding for Advancement
2013-01-21

21 January 2013

We are one of four South African universities that have been selected to take part in a multimillion-rand programme to bolster private fund-raising and Advancement efforts.

The UFS will receive US$640 000 (R5 612 800) over a period of five years to use in advancement efforts.

In total, the US-based Kresge Foundation will make US$2.5 million available to the four universities, which includes the UFS, Durban University of Technology (DUT), Tshwane University of Technology (TUT) and the University of Johannesburg (UJ), over the next five years as part of a joint initiative with Inyathelo: The South African Institute for Advancement, to support the long-term financial sustainability of higher education institutions in South Africa.

Kresge will also provide programmes and support aimed at enhancing student access to universities and improving graduation rates.

Bill Moses, who directs Kresge’s education programme, says declining government support means that South African university officials need to tap into diversified philanthropic and private funding if they want to enhance their institutions’ ability to serve students better. “Stronger Advancement skills are critical to their success and ultimately to getting more South African students into universities and completing degrees. Advancement is not just about raising funds. It is the practice of building, maintaining and improving support, skills and other resources to ensure the sustainability of an institution,” explains Moses.

 This latest Kresge initiative follows the success of a five-year partnership with Inyathelo that helped five high-profile South African institutions - the University of the Witwatersrand (Wits); the University of Pretoria (UP); the University of the Western Cape (UWC); the Cape Peninsula University of Technology (CPUT) and the Children’s Hospital Trust - increase their private fund-raising revenue threefold. The four universities will receive additional funding over the next five years and will serve as mentors to the new group of institutions.

In April last year, Kresge announced a new commitment to South African higher education that builds on its efforts in the United States to improve university access and help students succeed academically. Their ‘Promoting access and success at South African universities’ programme will seek to strengthen pathways to and through universities, especially for students who are often unprepared for university study. Moses says enhancing the ability of universities in South Africa to graduate the next generation of knowledge workers, will make it possible for the country to compete more effectively in the global economy. “Access to higher education in South Africa has improved dramatically since the end of Apartheid. A doubling of enrolment since 1994 has, however, contributed to serious challenges, including under-prepared students and disappointing graduation rates. We are confident that our programme will help address some of these obstacles to success,” says Moses.

Kresge has already funded several efforts that support its interest in strengthening pathways to and through universities this year, including a grant to the University of the Free State to expand the South African Survey of Student Engagement, as well as funding to the University of Pretoria to support a conference in January, which will highlight opportunities to promote access and success at South African universities.

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