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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 congratulates Wayde van Niekerk and other students for their national and international accomplishments
2015-09-17



Kovsies showing the world that success is inevitable
Photo: Johan Roux

Students from the University of the Free State (UFS) have not only conquered South Africa (SA), they have also left footprints in the world. During 2014 and 2015, our students have performed well in various fields.

A special celebratory event was held at the Bloemfontein Campus on Tuesday 15 September 2015. Members of the Rectorate, Student Representative Council (SRC), Grey College Secondary School personnel and former principal, Mr Johan Volsteedt, as well as UFS staff members and students gathered at the Callie Human Centre to congratulate those students who have recently represented the university with excellence atnational and global levels. Also present were representatives from the Department of Sports Arts Culture and Recreation (SACR) in the Free State and the Free State Sport Confederation (FSSC).

Sports leadership has proven to be one of Kovsies’ areas of expertise. From Wayde van Niekerk making international headlines as the 2015 Men’s 400m World Sprint Champion, to Nicole Walraven who was named as the SA under-21 Hockey 2015 Player of the Year, speaks the language of winners.

Wayde believes that his achievements are also for his family, friends, mentors, and the university community to rejoice in.“What I achieved is our achievement,” he said “the person I am today is because of the people around me.” Also supporting him at this event was MsAns Botha, his coach together with his family and friends.

Andricia Hinckemann’s commitment to promote environmental sustainability in light of the global warming crisis earned her the Miss Earth SA 2015 second princess status.

The UFS Debating Society also joined the ranks as highfliers when announced as South African National Universities Debating Champions for 2015. The UFS team competed in nine preliminary rounds. Devon Watson and NkahisengRalepeli from the UFS had to fight their way through nine preliminary rounds to the finals. Competing in the category English as a First Language, Devon and Nkahiseng brought yet another championship title home.

Success is music to our ears here at Kovsies, Veritas and Marjolein showed us that music can also symbolize success. These residence serenade groups took first and second place, respectively, at the 2015 ATKV National University Sêr competition.

Other students who have the world in their hands and are striving to make it a better place include Rolene Strauss (Miss World 2015), Elzane van der Berg (Deaf Miss South Africa 2014), the Shimlas (2015 Varsity Cup champions),KovsieNetball (2014 Varsity Netball champions and winners of 2014 National Premier League), KovsieTennis (2014 USSA Champions) and Varsity Sevens Champions 2015.

Prof Jonathan Jansen, Vice-Chancellor and Rector of the university remarked upon the inevitable nature of success amongst our university’s students. “Whether they are in athletics, netball, or debating, Kovsie students do well in every aspect of their lives.”

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