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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

Graduates convene with global leaders at the UFS 2015 Winter Graduation ceremonies
2015-07-07

Dr Hendrik Auret, dr Gerhard Bosman en dr Madelein Stoffberg.
Foto: Leonie Bolleurs

Photo Gallery 

The University of the Free State’s 2015 Winter Graduations, which took place from 1-2 July 2015 on the Bloemfontein Campus offered several highlights. Three global leaders received honorary doctorates. A further 2 000 degrees and diplomas were conferred to graduates in the seven faculties of the university.

For the first time in the history of the UFS, three PhDs in Architecture were awarded simultaneously. Hendrik Auret, Gerhard Bosman, and Madelein Stoffberg’s outstanding achievements are a milestone in the university’s pursuit of academic excellence.

Furthermore, three PhDs were conferred on graduates from the Department of Consumer Science in the Faculty of Natural and Agricultural Sciences. Ismari van der Merwe, Natasha Cronje, and Gloria Seiphetlheng set a precedent when they walked across the Callie Human stage to collect their doctorates at the same graduation ceremony.

This year, the university produced 66 Doctors of Philosophy in various fields of study. Six of these PhDs were awarded in the Department of Physics. Three graduates in the Department of Soil- and Crop- and Climate Sciences received PhDs at the Winter Graduation. They are Tesha Mardamootoo, Elmarie Kotzé, and David Chemei.

Dr John Samuel.
Photo: Johan Roux

Keynote speakers provide enlightenment to graduates

On Wednesday 1 July 2015, Dr John Samuel, SA’s leading education expert, addressed 707 diploma graduates from the Centre for Financial Planning Law and the School of Open Learning. For the graduates’ future reference, Samuel offered invaluable knowledge he had accumulated over the years as Chief Executive of the Nelson Mandela Foundation. “One of the lessons I have learnt was not only the importance of time, but it was in fact what being on time demonstrated,” he said. “Being on time was demonstrating respect, respect for the people you are meeting, and for the occasion.”

On the second day of graduation, Nataniël, South African singer, songwriter, and entertainer spoke to Master’s and doctoral graduates in the Faculties of Economic and Management Sciences, Humanities, Education, Health Sciences, Law, Theology, and Natural and Agricultural Sciences. His keynote spoke to the graduates’ sense of resolve in saying, “nothing is ever accidental. It is always with a purpose, it is your turn to make the world a better place.” He added that “it is important to strive for excellence and to be proud of what you are doing.”

Honorary doctorate recipients in a nutshell

Dr Samuel is one of the three exceptional global leaders to receive honorary doctorates from the university on 1 July 2015. His accolade was presented by the Faculty of Education. He has contributed to the Public Participation Education Network (PPEN) campaign as a founding member. He established the Centre for Education Policy Development, the Joint Working Group (for The National Party Government and the ANC), the National Education Conference, and the National Education and Training Forum. In addition, he made leadership contributions to the First Education and Training White Paper, the first Green Paper on Higher Education, and is the CEO of the Oprah Winfrey Leadership Academy for Girls. The WK Kellogg Foundation in the USA operates under his directorship.

Professor Heidi Hudson, Director of the Centre for Africa Studies at the UFS and Dr Lakhdar Brahimi.
Photo: Mike Rose from Mike Rose Photography

Dr Lakhdar Brahimi received an honorary doctorate from the Centre for Africa Studies. Algerian-born Brahimi was first involved with the United Nations (UN) in 1992, and has since been deployed all over the world on peacekeeping missions. Amongst many other countries, he has worked as a mediator for South Africa, Haiti, Afghanistan, Iraq, Syria, Democratic Republic of Congo, Cameroon, Burundi, Angola, Liberia, Nigeria, Sudan, and Côte d’Ivoire on behalf of the UN. He also played a direct role in South Africa’s democratic transition as a special representative in 1993/4.

Dr Mercy Amba Oduyoye received an honorary doctorate from the Faculty of Theology. Dr Oduyoye is widely regarded as one of the most influential women theologians in Africa. She was the first black woman to receive a degree in Theology in 1965 from Cambridge University in the United Kingdom. She continues to shift the paradigm of gender in theology internationally as the director of the Institute of African Women in Religion and Culture at the Trinity Theology Seminary in Ghana.

Dr Mercy Oduyoye.
Photo: Johan Roux

In closing the academic celebrations

Vice Rector: Academic, Dr Lis Lange, commended the class of 2014 for making their contribution to the educational system. Prof Jonathan Jansen, Vice Chancellor and Rector, also congratulated the graduates in closing.

“This is a day many have worked very hard towards, it is an enormous achievement as well as a development in the quality of research, and the courage to research,” he said in a vote of confidence.

Dr Khotso Mokhele, Chancellor of the UFS, applauded the university in light of the increased number of female graduates who completed their degrees with distinctions. The transcendence of demographics, both in terms of gender and race, on a postgraduate level, increases the hope of achieving gender equality in both the academic arena and South Africa.

More graduation news

A number of distinctions were also awarded during the two-day ceremony. For a list of these distinctions, follow this link.

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