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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

UFS awards honorary doctorate to global peace ambassador Dr Lakhdar Brahimi
2015-07-07

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

The Faculty of the Humanities and Centre for Africa Studies rewarded the contributions of Dr Lakhdar Brahimi, a prominent global peace leader, with an honorary doctorate on Thursday 2 July 2015.

The conferment formed one of the highlights of the 2015 Winter Graduations. Dr Brahimi’s work as a United Nations’ (UN) envoy, and African peace leader of note, was deeply respected by the university. Professor Heidi Hudson, Director of the Centre for Africa Studies at the UFS, accepted the PhD on his behalf.

In his acceptance speech, read by Prof Hudson at the Chancellor’s Dinner the same evening, Dr Brahimi expressed his gratitude to the university. “I deeply appreciate your generous recognition, and even now, in the twilight years of my life, I shall try to be worthy of your confidence in everything I say or do.”

“My generation did its share: its successes and its failures are things of the past. We must accept to be judged by you, the graduates. You, the young graduates here at the University of the Free State, and your fellow members of the African intellectual elite, have an exciting opportunity to take on the challenges and fulfil the dreams you have. We must accept to be judged by you.”

Algerian-born Dr Brahimi was first involved with the UN in 1992 as rapporteur to the Earth Summit. Distinctively, he is the most-frequently appointed special envoy of the UN. 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.

Significant peacekeeping efforts in South Africa (1993- 1994)

The ambassador– in his capacity as special representative to South Africa from December 1993 to June 1994 –played a direct role in South Africa’s democratic transition.

Prof Hudson expressed appreciation for the ambassador’s role in facilitating a peaceful transition from South Africa’s Nationalist government into the current democratic dispensation.

“One of the reasons we selected him as recipient of the honorary doctorate, is because of what he did for the African continent,” she said.

In addition, she commented Dr Brahimi for being a living testament of Ubuntu. “He has displayed an ethic of humanism in everything that he has done, in the way that he has mediated in certain conflicts - his main contribution is as a mediator.

According to Hudson, his humility, modesty, and generosity are the epitome of Ubuntu which states that “I am because we are.”

Dr Brahimi as a global peace practitioner

Dr Brahimi served as Undersecretary-General of the Arab League, Arab League Special Envoy for Lebanon, and Foreign Minister of Algeria.

The UN Peace-building Commission was established as a result of recommendations in his2000 Report of the Panel on United Nations Peace Operations (Brahimi Report).

Since 2007, Dr Brahimi has been a member in The Elders - an alliance chaired by Kofi Annan -of peace and human rights advocates including Desmond Tutu, Graça Machel, Mary Robinson, and Jimmy Carter. His passion for justice led to his membership in the Commission on Legal Empowerment of the Poor.

In 2010, he was Laureate of the Special Jury Prize for Conflict Prevention, awarded by the Chirac Foundation (France), which promotes international peace and security.

Dr Brahimi’s influence in Peace Education

The Brahimi Report has had an indelible impact on scholars specialising in the broad field of peace operations. Dr Brahimi’s writings have also contributed to knowledge on post-conflict reconstruction and development (PCRD), a signification part of the African Union’s narrative.

He is a distinguished senior fellow at the Centre for the Study of Global Governance at the London School of Economics. He has taught a postgraduate course on Conflict Resolution at Sciences Po, Paris (2011); is Andrew D. White Professor-at-Large at Cornell University; and is affiliated to the Institute for Advanced Studies at Princeton, where he was a visiting professor from 2006 to 2008.

In addition, Dr Brahimi is a founding member of the French-language Journal of Palestine Studies, and a board member of the Stockholm International Peace Research Institute.


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