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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

Kesa and Wayde biggest stars at KovsieSport Awards
2017-10-03

Description: 'Awards KovsieSport 2017 Tags: Awards KovsieSport 2017

Wayde van Niekerk was unable to attend the KovsieSport Awards.
Steven Swarts, his stepfather, received the award for KovsieSport
Senior Sportsman of the Year from Prof Francis Petersen (left),
Rector and Vice-Chancellor of the University of the Free State,
on his behalf.
Photo: Mlungisi Louw/Volksblad


It took Kesa Molotsane seven years of hard work and patience to excel, and all this time she has been a Kovsie. Unlike some other sporting greats, success didn’t come overnight for her. 

The star athlete had an amazing year and was crowned KovsieSport Senior Sportswoman of the Year, while Wayde van Niekerk is the KovsieSport Senior Sportsman of the Year for a fifth consecutive time. The 400 m Olympic Champion surpassed the record held by himself and Franz Kruger for most successive sports awards for men (four), and equalled Kruger’s record (five) for the most men’s titles overall.

Blose and Chawane top juniors

The cream of the crop was honoured at the KovsieSport Awards, held in collaboration with the Volksblad Free State Sport Stars Awards, at Monte Bello in Bloemfontein on 27 September 2017.

Kwenzo Blose, who represented the South African U20 rugby team at the Junior World Cup, was named Junior Sportsman for a second consecutive year. The netball player Khanyisa Chawane is the KovsieSport Junior Sportswoman of the Year. She captained the South African U21 netball team at the World Youth Netball Champs.

The blind athlete Louzanne Coetzee and her guide Khothatso Mokone received a Special Award for Disabled Sport. Coetzee took part in the Paralympic Games and has set many records, such as in the 5 000 m (T11).

Hard work over many years

Molotsane competed at the World Cross-country Championships in Kampala, is the leader of the Spar Women’s Grand Prix 10 km series, and represented South Africa at the World Student Games. The Assistant Officer at KovsieSport says being the best female athlete is humbling. 

“It took me long enough to get here and it needed a lot of work from my side over many years. I have been with Kovsies for, like, seven years and I am only getting this after so long.”
She also commended Karla and Tanya Mostert who was nominated with her. “Karla has been a motivation for little kids from primary school up until high school learners. She has always been there and knows what it means to really be a sport star. 

“And her younger sister Tanya is the upcoming one. It is amazing to be on stage with both of them.”

KovsieSport Awards:
Participants in World Student Games in Tapei: Arné Nel (tennis), Hendrik Maartens (athletics), Janke van der Vyver (badminton), Kesa Molotsane (athletics), Lienke de Kock (tennis), Maryke Brits (athletics), Rynardt van Rensburg (athletics), Tsepang Sello (athletics).
Special Award for Disabled Sport: Louzanne Coetzee and Khothatso Mokone
Special Awards: Maryka Holtzhausen (netball), Janine de Kock, Marnus Kleinhans (tennis), Ans Botha, Rufus Botha (both athletics), Nicole Walraven (hockey) and Godfrey Tenoff (soccer)
Junior Sportswoman of the Year: Khanyisa Chawane (netball)
Junior Sportsman of the Year: Kwenzo Blose (rugby)
Senior Sportswoman of the Year: Kesa Molotsane (athletics)
Senior Sportsman of the Year: Wayde van Niekerk (athletics)

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