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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

King Moshoeshoe comes alive on national television
2004-11-02

Honourable Bethuel Pakalitha Mosisili, Prime Minister of Lesotho, and his wife; King Letsie III of Lesotho and Dr Ezekiel Moraka, Vice-Rector: Student Affairs at the UFS during the première of the film at the Royal Palace in Lesotho

The ground-breaking documentary film on the life and legacy of King Moshoeshoe, the founder of the Basotho nation, will come alive on Thursday 4 November 2004 when it is screened on SABC2 at 21:00

The film, called Moshoeshoe: The Renaissance King, forms part of a larger project by the University of the Free State (UFS) to honour the Moshoeshoe legacy of nation-building and reconciliation and to explore his role as a model of African leadership. It was produced by the well-known journalist Mr Max du Preez and commissioned by the UFS as part of its centenary celebrations.

The SABC2 screening was preceded by a première in Bloemfontein last month, and was attended by provincial political leaders.

This past weekend there was a première at the Royal Palace in Lesotho, which was attended by King Letsie III, the prime minister, the chief justice, judges, the president of the senate, cabinet ministers and directors-general.

“Through this documentary film the UFS commits itself to developing a shared appreciation of the history of this country and to the establishment of the Free State Province as a model of reconciliation and nation-building. King Moshoeshoe is also a strong common element, and binding factor, in the relationship between South Africa/the Free State, and its neighbour, Lesotho,” said Prof Frederick Fourie, Rector and Vice-Chancellor of the UFS.

“Not all people in South Africa know the history of Moshoeshoe. Many Basotho – but not all – are well versed in the history of Moshoeshoe, and his name is honoured in many a street, town and township. Many white people know little of him, or have a very constrained or even biased view of his role and legacy. In Africa and the world, he is much less known than, for instance, Shaka,” said Prof Fourie.

“King Moshoeshoe did a remarkable thing in forging a new nation out of a fragmented society. He also created a remarkable spirit of reconciliation and a remarkable spirit of leadership,” said Prof Fourie.

According to Prof Fourie we already benefit from his legacy: the people of the Free State share a tradition of moderation and reconciliation rather than one of aggression and domination. “For the UFS this is also part of real transformation – of creating a new unity amidst our diversity,” said Prof Fourie.

“We also find in the legacy of King Moshoeshoe the possibility of a “founding philosophy”, or “defining philosophy”, for the African renaissance. To develop this philosophy, we must gain a deeper understanding of what really happened there, of his role, of his leadership. Therefore the UFS will encourage and support further research into the history, politics and sociology of the Moshoeshoe period, including his leadership style,” said Prof Fourie.

Media release
Issued by: Lacea Loader
Media Representative
Tel: (051) 401-2584
Cell: 083 645 2454
E-mail: loaderl.stg@mail.uovs.ac.za
2 November 2004

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