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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

Moshoeshoe Memorial Lecture to focus on Leadership challenges
2006-03-27

 Lecture to focus on Leadership challenges

 n Thursday 25 May 2006 – Africa Day – the University of the Free State (UFS) will host the inaugural King Moshoeshoe Memorial Lecture in honour of this great African leader and nation-builder.

 Prof Njabulo Ndebele, internationally renowned writer and academic, and Vice-Chancellor of the University of Cape Town (UCT), will deliver the inaugural lecture at the Main Campus in Bloemfontein on the topic: Reflections on the Leadership Challenges in South Africa.

 “I see the lecture as part of a larger debate on leadership models, particularly the concept of African leadership, as well as the ongoing discourse about nation-building and reconciliation,” says Prof Frederick Fourie, Rector and Vice-Chancellor of the UFS.

 According to Prof Fourie, the Moshoeshoe project was launched at the UFS in 2004 to coincide with South Africa’s first decade of democracy and was part of the University’s centenary celebrations, having been founded in 1904.

 “Through this project the UFS seeks to honour a great African leader and demonstrate our commitment to transformation so as to create a truly inclusive and non-racial university,” said Prof Fourie.

 “As the founder of the Basotho nation, King Moshoeshoe is widely credited for his exceptional style of leadership, displaying the characteristics of diplomacy, reconciliation and peaceful co-existence in his efforts to unite diverse groups into one nation,” said Prof Fourie.

 As part of its ongoing Moshoeshoe project, the UFS commissioned a television documentary programme on the life and legacy of King Moshoeshoe. This was completed in 2004 and broadcast on SABC 2 later that year.


Abridged curriculum vitae of Njabulo S Ndebele

Professor Njabulo S Ndebele is currently Vice-Chancellor and Principal of UCT.

 Njabulo Ndebele began his term of office at UCT in July 2000, following tenure as a scholar in residence at the Ford Foundation’s headquarters in New York.  He joined the Foundation in September 1998, immediately after a five-year term of office as Vice-Chancellor and Principal of the University of the North in Sovenga, at the then Northern Province.  Previously he served as Vice-Rector of the University of the Western Cape.  Earlier positions include Chair of the Department of African Literature at the University of the Witwatersrand; and Pro-Vice-Chancellor, Dean, and Head of the English Department at the National University of Lesotho.

 An established author, Njabulo Ndebele recently published a novel The Cry of Winnie Mandela to critical acclaim.  An earlier publication Fools and Other Stories won the Noma Award, Africa’s highest literary award for the best book published in Africa in 1984.  His highly influential essays on South African literature and culture were published in a collection Rediscovery of the Ordinary.

 Njabulo Ndebele served as President of the Congress of South African Writers for many years.  As a public figure he is known for his incisive insights in commentaries on a range of public issues in South Africa.  He holds honorary doctorates from Universities in the Netherlands, Japan, South Africa and the United States of America.  He is also a Fellow of UCT.

Njabulo Ndebele is also a key figure in South African higher education.  He has served as Chair of the South African Universities Vice-Chancellor’s Association from 2002-2005, and served on the Executive Board of the Association of African Universities since 2001.  He has done public service in South Africa in the areas of broadcasting policy, school curriculum in history, and more recently as chair of a government commission on the development and use of African languages as media of instruction in South African higher education.  He recently became President of the Association of the AAU and Chair of the Southern African Regional Universities Association (SARUA).

Media release
Issued by: Lacea Loader
Media Representative
Tel:   (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za 
26 March 2006

 

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