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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

Graduates challenged to fulfil their leadership obligations
2015-12-14



Procession frontline: seen making their way to the graduation ceremony are from left: Dr Khotso Mokhele (Chancellor of the UFS), Prof Busisiwe Bhengu (Chairperson of the South African Nursing Council), and Prof Jonathan Jansen (Vice-Chancellor of the UFS).
Photo: Johan Roux

The time for one-dimensional discourse was over, said Professor Busisiwe Bhengu, the guest speaker at this year’s Summer Graduation. Practical implementation of change was the step forward in forging the path into a brighter South Africa future.

During both the morning and afternoon ceremonies held at the University of the Free State (UFS) Bloemfontein Campus on 10 December 2015, the Chairperson of the South African Nursing Council, and Associate Professor at the University of KwaZulu-Natal, challenged the newly-graduated alumni to rise to the occasion, and be a part of the solution to our country’s diverse challenges.

Some of the pervasive hardships she highlighted were human immunodeficiency virus (HIV) and tuberculosis (TB), the escalating number of orphans and child-headed households, and the human resource shortages resulting from an ageing generation which is exiting the employment system through retirement.

Prior to dissolving the congregations, Dr Khotso Mokhele, the Chancellor of the UFS, said: “I was caught by the leadership challenge she [Prof Bhengu] threw out at the graduates because we indeed need courageous, creative and innovative leaders moving forward,” he said.

Dr Mokhele touched on South Africa’s dwindling economy, the leadership issues engulfing the government currently, the #FeesMustFall movement, and how students led a difficult dialogue and dictated the country’s trajectory as regards education, as well as the water scarcity we are facing. In closing, he warned that the graduates had lost the luxury of feeling led because of the fact that they now have a leadership obligation to fulfil.

Highlights of the day

Amongst 102 graduates from the UFS School of Medicine were two brothers from the Free State, Johann and Rudi Westraad who followed each other’s passion to become doctors.

Deputy Registrar at the UFS, Elna Van Pletzen, graduated with a Master’s in Higher Education Studies. Her thesis titled ”The implications of current legislative changes for academic freedom and institutional autonomy of South African higher education institutions”, focused on the amendment of Higher Education and Training Laws Amendment Act of 2012. In it, she tackled the subjects of academic freedom and the relationship between government and higher education institutions. Coincidently, her research was produced at a time when the subject of university autonomy was on the national agenda.

The occasion was not only a celebration of the students; teachers were also recognised for their dedication to quality education. Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS congratulated Dr Louise van den Berg (Faculty of Health Sciences) as well as Naquita Fernandes and Salomien Boshoff (both from the Faculty of Economic and Management Sciences) for their outstanding achievements. At a recent ceremony, Dr Van den Berg received the Vice-Chancellor’s Award for an individual teacher, and the Vice-Chancellor’s Award for the best teaching team was presented to Fernandes and Boshoff.

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