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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

Winning culture helps Kovsies Tennis team claim ninth gold
2015-12-09


Ruben Kruger of the University of the Free State in action at the 2015 USSA tournament in Cape Town.
Photo: Janine de Kock

A winning culture in the Kovsies Tennis Team, combined with good planning, contributed to the University of the Free State (UFS) USSA success recipe.

This is what Janine Erasmus, one of the team's captains, had to say.

According to her, this is why the UFS were able to handle the pressure of being the favourite so well, and this is what helped her team to achieve a ninth consecutive gold medal in Cape Town on 4 December 2015.

This was the sixth year in a row that the UFS triumphed in the combined USSA format since its inception in 2010. In 2007 and 2008, its Women's team won gold, and in 2009, it was the Men's team.

Erasmus was full of praise for the Kovsie coach, Marnus Kleinhans, and Janine de Kock, manager of KovsieTennis.

“We had a build-up of a few months to the USSA tournament, and they (Kleinhans and De Kock) already knew exactly what to do,” she said.

Erasmus, who won a third gold medal, believes her team had great depth this year.

Four in select squad

Kovsies and Maties played in the USSA Tennis Finals for a fourth consecutive year.

Erasmus and her team beat the Stellenbosch team 7 - 3 on 4 December 2015, after they defeated Tukkies 8 - 0 in their semi-final.

 

Mareli Bojé is one of four tennis players of the University of the Free State included in a 2015 USSA tournament team.
Photo: Janine de Kock

Arné Nel, Cornelius Rall, Duke Munro, and Mareli Bojé are the four Kovsies included in the USSA tournament team.

Nel, the other captain from the UFS, won all his matches for the third successive year. Munro won a gold medal at USSA for the seventh year in a row.

Gold for Table Tennis


Three UFS sports teams made it to the USSA finals, all against Maties. The tennis and men's table tennis teams were both winners, but the Sevens rugby team got stuck.

The Kovsie table tennis team beat Maties 3 - 1 in Kimberley.

Silver for Sevens rugby

The Kovsie Sevens rugby team, third at USSA for the past two years, walked away with silver in George on 1 December 2015.

The team was defeated by Maties 10 - 31 in the final. This was after they won 24 - 14 against Pukke in the semi-final, and 28 - 12 against the Central University of Technology in the quarter final.

Tukkies, the 2014 USSA Sevens champions, together with several other teams, did not take part  because the tournament was postponed because of the nationwide student protests.

The Kovsie swimming team took part in the USSA tournament in Johannesburg from 28 November to 30 November 2015.


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