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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 academics present papers at major conference
2009-07-23

 
Pictured from the left are: Prof Neethling, Prof Edna van Harte (Dean of the Faculty of Military Science, Stellenbosch University), Dr Thomas Mandrup (from the Royal Danish Defence College and co-organiser of the conference), and Prof Heidi Hudson.
Photo: Supplied


Prof Theo Neethling from the Department of Political Science was recently invited to address a conference on the theoretical basis for states’ use of military instruments of force and scholarly progress in the understanding of armed conflict in Africa held at Stellenbosch University (SU) on 11 and 12 June 2009. This conference, themed Strategic Theory and Contemporary Africa Conflicts, was presented by the Faculty of Military Science of SU in collaboration with the Faculty of Military and Strategic Studies of the Royal Danish Defence College in Copenhagen. The conference was premised on the point that the way in which states choose to become involved in, orchestrate or oppose armed conflicts in terms of peace intervention action, normally originates from theoretical thinking well-grounded in a national strategy. This was the first conference in South Africa that focused on the nature of such a national strategy, but also on how the incidence of recent armed conflicts in Africa could be explained in terms of this theoretical thinking. In view of this Prof Neethling’s paper was titled, “UN peacekeeping operations in Africa: Reflections on developments, trends and the way forward”. His paper focused on recent and current UN peacekeeping operations with special reference to multinational challenges in the African context.


Prof. Heidi Hudson from the Centre for African Studies also attended the conference in Stellenbosch on Strategic Theory and Contemporary Africa Conflicts. In addition she was invited to present a paper at the Peacekeeping Africa 2009 conference held on 24 and 25 June 2009 at Gallagher Estate, Midrand. The event brings together individuals who are experts in defence, peacekeeping, policing, foreign service and other government bodies to share knowledge and to discuss the latest developments. This year’s conference was attended by more than 100 experts from all over Africa, with strong representation from the UN and the International Red Cross. Prof. Hudson’s paper was entitled “Peacebuilding through a gender lens”. Her presentation examined lessons learnt with regard to implementation of a gender perspective in Côte d’Ivoire and Rwanda. These case studies point towards an empirical link between women’s inclusion in peace processes and the quality of peace finally achieved. Prof. Hudson warned that inattention to the differential needs of both women and men during conflict and in the post-conflict reconstruction phase may perpetuate the violence discourses which sustained the conflict in the first place.

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