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Global body re-affirms UFS lab’s vaccine testing status

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

Internationally acclaimed academic applauded on Africa Day

2011-06-02

Prof. Ali Mazrui, an internationally acclaimed and renowned academic.

One of the world’s top academics was given a warm welcome in the rather cold Free State recently.

Prof. Ali Mazrui, an internationally acclaimed and renowned academic, visited us as part of our Africa Day celebrations as arranged by the Centre for Africa Studies. He delivered a keynote address, entitled ‘Pro-democracy uprisings in an African experience: from Sharpeville to Benghazi.’

A festive atmosphere and the sound of drums welcomed this intellectual giant as well as other delegates upon their arrival at the CR Swart Auditorium on our Bloemfontein Campus. Some of the delegates who attended the Africa Day Celebrations, included: Mr Tom Amolo, High Commissioner from the Republic of Kenya; Mr Dan Kgothule, MEC of Arts and Culture in the province; Prof. Jeff and Dr Carla Ramsdell, visitors from America; Dr Allan Boesak and Prof. Nicky Morgan, Vice-Rector: Operations.

Prof. Frederick Fourie, former Vice-Chancellor and Rector of our university, also attended the celebrations, as did some scholars from neighboring schools.

Welcoming Prof. Mazrui, Prof. Jonathan Jansen, Vice-Chancellor and Rector of our university, quipped that he was relieved the world had not ended the previous weekend as was predicted, because he was looking forward to listening to such a renowned intellectual.

Prof. Lucius Botes, Dean of Humanities, followed Prof. Jansen at the podium. He said the ability to go from following a bridging course to being one of the top 100 intellectuals in the world, indeed distinguishes Prof. Mazrui as an exceptional academic. This intellectual is, among others, an Albert Luthuli Professor at the University of Jos, Nigeria and Andrew D. Professor Emeritus and Senior Scholar in Africana Studies at Cornell University.

In his introduction, Prof. Mazrui said he feels honored and flattered by this opportunity. He proceeded by referring to the history of Africa Day and added that he would rather prefer an Africa Week to an Africa Day to ensure that everybody has the opportunity to celebrate the continent.

He sang the praises of South Africa, as almost every other African country which attained liberation from European colonial rule in the 20th century, has been unable to maintain its democratic order beyond its first decade of independence.

“The Republic of South Africa, on the other hand, liberated Nelson Mandela in 1990, held its first democratic election in 1994, and already has its third president. Nearly two decades after Apartheid, South Africa has not outlawed opposition parties, or experienced a military coup, or permitted the Head of State to govern the country as a dictator.”

In his speech he compared the uprisings in Sharpeville during 1960 and Soweto during 1976 with the more recent pro-democracy uprisings in North Africa, based on the role that weapons and the lack thereof, as well as the youth and women played in the respective cases.

He concluded by saying the uprisings in Tunisia and Egypt have already resulted in ousting dictators who had been entrenched in power for decades, adding that in Libya a third dictator’s future is on the line. “Never in the history of the Arabs have there been so many popular uprisings which seem to be inspired neither by Islam nor by anti-imperialism, but in the quest for liberal reforms. Half a century earlier in Sharpeville and Soweto, South Africans experienced their own political awakening.”

Prof. Kwandiwe Kondlo, Director of the Centre for Africa Studies, closed the event with a word of thanks to the American academic and his wife, guests and attendees. He said discussions prior to the event revealed that more research has to be done regarding gender issues on the continent.

Prof. Mazrui also participated in conversations at the institute and a media briefing which was hosted earlier the day.

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