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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 Council unanimously reappoints Dr Khotso Mokhele as Chancellor
2015-04-02

 

Dr Khotso Mokhele, Chancellor of the University of the Free State

The Council of the University of the Free State (UFS) unanimously reappointed Dr Khotso Mokhele as Chancellor during its quarterly meeting held on 13 March 2015. He was first appointed in this portfolio by the Council on 4 June 2010.

“It is an honour for the Council to reappoint someone of this stature as Chancellor of the UFS. With his solid academic background and high profile in the business world, Dr Mokhele has been a great asset to the UFS. On behalf of the Council and the university community, I extend a word of appreciation for the work he has done during his first term as Chancellor of the UFS. He is an exceptional leader, and the university community is looking forward to have him as Chancellor for a second term,” said Judge Ian van der Merwe, Chairperson of the UFS Council.

Dr Mokhele was awarded a BSc Agriculture from Fort Hare University, and continued his studies at the University of California Davis (USA) on the Fulbright-Hays Scholarship Programme, completing his MSc (Food Science) and PhD (Microbiology). He was subsequently a postdoctoral fellow at Johns Hopkins University School of Medicine (USA) and the University of Pennsylvania School of Medicine (USA). Dr Mokhele is the recipient of honorary doctorates from nine South African universities including the UFS, and from Rutgers University in the USA.

He was Chairman of the Rhodes Scholarship Selection Committee for Botswana, Malawi, Namibia, Lesotho and Swaziland (2007-2011), and served on the South Africa at Large Rhodes Scholarship Selection Committee for more than 10 years. As President and Chief Executive Officer (CEO) of the Foundation for Research Development (1996-1999) and the NRF from 1999 to 2006, Dr Mokhele played a central role in providing visionary and strategic direction to the South African science system. He was the Founder President of the Academy of Science of South Africa (ASSAf), Founder President and CEO of the National Research Foundation (NRF), Chairperson of the Economic Advisory Council to the Premier of the Free State (2001-2004), and a member of the Advisory Council on Innovation to the Minister of Science and Technology (2003-2007). His role in securing government and international support for the Southern African Large Telescope Project (SALT) is evidence of his dedication to science in South Africa. The success of this project laid the basis for South Africa being selected to host more than 70% of the Square Kilometre Array, an international mega telescope for radio astronomy.

In recognition of his contribution to the development of science, he was the recipient of the Technology Top 100 Lifetime Achievers Award in 2009 and the National Science and Technology Forum Award in 2005. His role in science is recognised internationally. He was an elected Vice-President: Scientific Planning and Review of the International Council for Science and Chairperson of its Committee for Scientific Planning and Review (2005-2008) as well as a member of the Committee on Developing and Transition Economy Countries of the International Social Science Council (2008-2010). He also represented South Africa on the executive board of UNESCO, and was awarded the Member Legion of Honour of the Republic of France for his work in strengthening scientific ties between South Africa and France.

Dr Mokhele currently serves as Special Advisor to the Minister of Science and Technology, the Honourable Naledi Pandor. His current corporate positions include: Non-Executive Chairman: Board of Directors, Impala Platinum Holdings Ltd (Implats); Lead Independent Non-Executive Director: African Oxygen Ltd (Afrox); Non-Executive Director of Zimbabwe Platinum Holdings Ltd (Zimplats); Hans Merensky Holdings Ltd; and Tiger Brands Ltd. He is the President of the Hans Merensky Foundation (South Africa) and a Trustee of SciDev.Net (a web-based scientific magazine based in London, UK) and Start International Inc (USA).

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