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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

Dr Khotso Mokhele joins ranks of distinguished Chancellors
2010-11-21

Attending the inauguration ceremony are, from the left: Mr Pule Makgoe, MEC for Education in the Free State and member of the UFS Council; Judge Ian van der Merwe, Chairperson of the UFS Council; Dr Khotso Mokhele, newly inaugurated Chancellor of the UFS; and Prof. Jonathan Jansen, Vice-Chancellor and Rector of the UFS.
Photo: Dries Myburgh

Dr Khotso Mokhele joined the ranks of distinguished Chancellors of the University of the Free State (UFS) with his inauguration as the new Chancellor of the institution at a ceremony on Friday, 19 November 2010.

The lustrous ceremony took place on the Main Campus in Bloemfontein and was attended by hundreds of guests from all over South Africa.

Dr Mokhele said in his speech: “I am excited to have been invited by the UFS to join its community at the time when it is attempting to reinvent itself into an institution that will be counted amongst those that will shape the local, regional, national will, and by so doing, contribute to the shaping of an African will.”

Dr Mokhele follows in the footsteps of Dr Franklin Sonn, former Ambassador of South Africa in the United States of America and receiver of many awards, acknowledgements, and honorary doctorates, who retired earlier this year. Dr Sonn was preceded by Ms Winkie Direko, former premier of the Free State.

His acceptance of the role of Chancellor is a great honour for the UFS.

According to Prof. Jonathan Jansen, Vice-Chancellor and Rector of the UFS, it is a proud moment to welcome someone from the Province as the Chancellor of this university. With his strong academic values and deep sense of human compassion, Dr Mokhele is one of but a few uncompromising leaders. He is also an inspiring, determined pioneer and a role model to all our students.

Few have done as much to guide the development of science in South Africa since democracy in 1994 as Dr Mokhele. His vision and actions as a senior science manager have been guided by his deep conviction that for a truly democratic society to emerge in South Africa all people must be empowered to be its architects and must have unhindered access to those careers upon which our economy is built.

Dr Khotso Mokhele was born and raised in Bloemfontein. After matriculating from the Moroka High School he went on to study at Fort Hare, where he graduated with a B.Sc. in Agriculture, winning the Massey-Ferguson award for the best student in that field. As a recipient of the prestigious Fulbright-Hays Scholarship, he entered the University of California in Davis where he took a M.Sc. and a Ph.D. degree, both in Microbiology. He was awarded post-doctoral fellowships at the Johns Hopkins University School of Medicine in Baltimore, Maryland, and at the University of Pennsylvania, Philadelphia.

Dr Mokhele returned to South Africa in 1987, set on becoming a top-class academic and researcher. He held lecturing posts at the Universities of Fort Hare (1987-1989) and Cape Town (1990-1992). In 1992 he joined the Foundation for Research Development (FRD) as one of its Vice-Presidents. He succeeded to its presidency in 1996 and then from 1999 to 2006 became the first President of the National Research Foundation (NRF).  He successfully merged the FRD and the Centre for Science Development of the Human Sciences Research Council. Under his visionary leadership the NRF has come to play a pivotal role in the development agenda of the country. He was also instrumental in the establishment of the South African Academy of Sciences serving as its founder president (1996-1998).

Dr Khotso Mokhele's contribution to science in South Africa has received wide recognition locally and abroad. He has received nine honorary doctorates. He was made a Chevalier of the Legion of Honour by the President of France in recognition of his personal efforts in strengthening scientific ties between France and South Africa, and was appointed a director of the Salzburg Seminar, an institution focused on global change, and subsequently a member of its Council of Senior Fellows.

He also serves on the boards of major companies such as Implats, Adcock Ingram and Afrox.

Media Release
Issued by: Lacea Loader
Director: Strategic Communication (actg)
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl@ufs.ac.za19 November 2010
 

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