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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

SRC visits the US as part of Global Leadership Preparation Programme
2012-06-07

The Student Representative Councils (SRC) of the University of the Free State’s (UFS) Bloemfontein and Qwaqwa Campuses will be travelling to the United States from 10-24 June 2012 on an intensive leadership development programme.

The Global Leadership Preparation Programme, initiated by the Vice-Chancellor and Rector, Prof. Jonathan Jansen, has been designed to ensure that South Africa’s next generation of leaders understand their unique place in a global context, the interconnectedness of global and local society and various possibilities for change.
 
The group of 36 students will be visiting Washington DC, Boston and New York.
 
“As a university we recognise that students who lead on campus must be prepared to also lead the country, which requires amongst others greater understanding of the impact and influence of global developments (social, economic, political) on nation states and campuses. This includes knowledge to deepen democratic participation and real representation – issues we know that often are contested in important student governance structures such as SRCs,” says Mr Rudi Buys, Dean of Student Affairs.
 
The group will be studying among others the impact, influence and limits of the United Nations in global leadership; the impact of transnational companies on economic policies of African countries; the impact of American universities on African leadership; the impact of international philanthropy on African development and the impact of American public institutions on learning among the disadvantaged: lessons for South Africa.
 
The programme complements and strengthens other leadership preparation programmes of the UFS, such as the Leadership for Change Programme and the Gateway College Programme – an intensive orientation programme for all undergraduate students. It will give students a competitive advantage in leadership over more local programmes and initiatives that seldom look beyond the campus, or even beyond the country, in preparing the next generation of leadership.
 
“We value this initiative by the university leadership to give us the opportunity to explore and spread our wings and gather as much knowledge as we can get to raise the bar in terms of student governance and leadership. The university is amongst the few in the country that sees the need to strengthen and develop its student leadership by exposing it and allowing it to understand its role in a global context. This is a chance that we take seriously and we intend to use it to the betterment of the institution,” says Bongani Ngcanga, President of the Central SRC.
 
“While we welcomed the initiative taken by the university to design this programme, the SRC questioned and debated heavily on the merits and real contribution of such a programme. Only on approval of the academic and development profile of the programme did we accept its merits and now are excited about the value thereof. This opportunity goes beyond the term of the SRC and will develop and equip us for the great positions we will hold in the future. I am looking forward to meeting influential lobbyists, profound academics and strong politicians,” says Richard Chemaly, SRC President of the Bloemfontein Campus.
 
Upon their return, the SRCs will set a new benchmark for future councils, raising the bar to that of internationally acclaimed student leadership. One of the objectives of the programme is to produce written, reflective statements about the learning that resulted from the trip and to start dialogues in order to improve student governance and governance as a whole. Workshops will also be presented for aspirant student leaders on leadership lessons learnt from an international perspective.
 
Members of the SRCs are covering part in the cost of the programme and generous contributions have also been received from outside the university.

Media Release
07 June 2012
Issued by: Lacea Loader
Director: Strategic Communication
Tel: +27(0)51 401 2584
Cell: +27(0)83 645 2454
E-mail: news@ufs.ac.za

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