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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

Culture contributes to success of UFS rugby teams
2015-12-15

The Sevens team of the University of the Free State followed in the footsteps of the Shimlas when the team was crowned national champion. The Kovsies Sevens team beat Tukkies April in the final of the Varsity Sevens tournament. Photo: Supplied. 

The University of the Free State (UFS) Rugby Club has succeeded once again in creating a culture of values.

Marius van Rensburg, Chairman of the UFS Rugby Club, believes this was one of the reasons why Kovsies had so many rugby successes this year.

The UFS knows that money, which is more abundant at bigger universities, won't change the club into a rugby force, but "there is something special here," he said.

Van Rensburg added that the success of Shimlas, who won the Varsity Cup for the first time, also helped to build a winning culture.

Seven finals

Seven of the UFS Rugby Club's teams played in finals during 2015.

Shimlas beat the Pukke in the Varsity Cup final at Shimla Park on the Bloemfontein Campus.

The Kovsie Young Guns (against Tukkies) and Vishuis (Mopanie from Tukkies) got stuck in Bloemfontein in Varsity Cup finals.

The Shimlas won Section B of the USSA tournament in Johannesburg (against Madibaz in the final).

A strong Irawa rugby team beat Shimlas in the City Cup.

The Kovsie Sevens team was crowned as the Varsity Champions in Cape Town after beating Tukkies in the final. The team was beaten by Maties in the final of the USSA Sevens tournament in George.

Shimlas lays foundation

According to Van Rensburg, the Varsity Cup triumph by Shimlas laid a good foundation.

“After what happened in the Varsity Cup, the winning culture kind of washed over the other teams,” he said.

He also thinks the 2015 successes didn't happen overnight, but that the club managed to bring back good values. He feels that Franco Smith, the former Shimlas coach who is the Cheetahs’ current coach, also played an important part.

Greater pressure in 2016

In 2016, the UFS's rugby teams will have a greater target on their backs.

Van Rensburg agrees that there will be greater pressure, but the structures are in place.

He feels that Varsity Cup success goes together with a touch of luck, of which Shimlas had some this year.

“Looking at the draw, Shimlas will play their first two matches away against Ikeys and Tukkies. Therefore, after two matches, one might have no league points, and that would place the team under immediate pressure.”

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