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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

Three receive PhD degrees in Architecture at Winter Graduation ceremony
2015-07-08

Dr Hendrik Auret, Dr Gerhard Bosman and Dr Madelein Stoffberg.
Photo: Leonie Bolleurs

Three graduates from the University of the Free State’s (UFS) Department of Architecture received their PhD degrees at the 2015 Winter Graduation ceremony on the Bloemfontein Campus. According to Prof Walter Peters from Architecture, this is the first time in the history of the UFS that three PhD degrees in Architecture have been awarded simultaneously. It is country-wide a rare occurrence for three PhDs to be awarded in Architecture at one graduation ceremony.

“Previously, the UFS has only ever awarded a single PhD in Architecture, and that was in 1987, to Leon Roodt, a former head of the department. The first UFS honorary doctorate in Architecture was conferred on Gerard Moerdijk, architect of the Afrikaner church and the Voortrekker Monument. Gawie Fagan and Prof Bannie Britz, late head of the Department of Architecture, were other recipients of an honorary doctorate in Architecture,” said Prof Peters.

At the 2015 Winter Graduation ceremony, the UFS conferred PhDs in Architecture on Hendrik Auret from Roodt Architects in Bloemfontein as well as on Gerhard Bosman, and Madelein Stoffberg from the UFS Department of Architecture.

Dr Hendrik Auret

As an Architecture student at the university, Dr Auret obtained the degree BArchStud in 2004, a BArchStud (Hons) in 2005, and a March (Prof) in 2006, all cum laude. His Master’s design dissertation was judged the best from all South African Architecture learning sites, earning him the coveted ‘Corobrik Architectural Student of the Year’ award.

The work of the Norwegian architect and theorist, Christian Norberg-Schulz, served as the basis of Dr Auret’s PhD thesis, Care, place and architecture: a critical reading of Christian Norberg-Schulz’s architectural interpretation of Martin Heidegger’s philosophy, which considered the cogency of Norberg-Schulz’s architectural ‘translation’ of the German philosopher Heidegger’s thinking.

Dr Gerhard Bosman

On obtaining his BArchStud. and BArch degrees at the university in 1993 and 1995 respectively, Dr Bosman immediately joined the part-time staff of the Department of Architecture. As a lecturer in Building Construction, he developed an interest in vernacular and indigenous methods and techniques. Consequently, he built the first family home in Bloemfontein, for his wife, Debbie, and their two children, of earth construction, which been previously but erroneously considered inferior.

Despite that negative perception, Dr Bosman persuade the university to allow him to undertake post-graduate studies at the International Center for Earth Architecture (CRATerre-ENSAG) within the Ecole d' Architecture de Grenoble, France, from which institution,he was awarded the DPEA-Architecture de Terre qualification in 2000. In 2001,Dr Bosman was appointed to the full-time staff.

In 2003, when the opportunity arose, he became involved with SANPAD, the South Africa-Netherlands Research Project on Alternatives in Development, which lead ultimately to his PhD thesis: The acceptability of earth-constructed houses in central areas of South Africa.

Dr Madelein Stoffberg

In 2005, Dr Stoffberg enrolled as an Architecture student at the UFS, obtaining her BArchStud degree in 2007, the BArchStud (Hons) in 2008 and the March (Prof) in 2009, the latter cum laude. Immediately on graduating, Dr Stoffberg was appointed to her position as a part-time junior lecturer in the Department of Architecture.

During her studies, her attention was drawn to the concept of the spatial triad of Henri Lefebvre. Fascinated with the conceptand by the development of community centres as a contemporary architectural typology, she began her PhD degree.  

Entitled Lived reality, perception and architecture: two community centres interrogated through the lens of Lefebvre’s spatial triad, Dr Stoffberg investigated the relationship between the spatial understanding of the project architect and the community of two completed buildings in Port Elizabeth. She established a mismatch in perception, representation, and use of space, which could be bridged, however, by way of a qualitative research approach, instead of a quantitative one.


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