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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

Kovsies triumph in Free State hockey
2014-08-05

During the first weekend of August 2014, the University of the Free State (UFS) was once again crowned as the Free State hockey champions.

In the finals of the Free State championships, the Kovsies’ women’s team beat the Reds (Kovsies 2nd team) by 10-1. This is the ninth consecutive year that our women’s team walk away as champions. It was clear from the start that Kovsies wouldn’t be satisfied by anything less than a win and a courageous Reds team was unable to cover all the gaps.

After being at the helm for three years, the Kovsies’ coach, Jacques du Toit, announced his retirement after the game. During his coaching term, Kovsies had their best performances since the 1984 season – when the Kovsie women won the University Sports South Africa (USSA) tournament.

Since 2012, the Kovsies’ women’s team went from strength to strength. For the first time since 1993, they ended among the top four teams in the USSA tournament that year. In the following year they repeated this performance and also achieved a bronze during the first Varsity Sport Hockey tournament for women.

Kovsies’ men’s hockey team was also crowned as champions in the Free State championships for the 12th consecutive year. We won against the Central University of Technology in the finals by 9-2. This year our team of champions also succeeded in breaking a medal drought of 30 years in the USSA tournament. We defeated the team from the University of Johannesburg to gain a bronze.

This year, Kovsies was also the only university that managed to win two medals at the USSA hockey tournament and can rightfully claim the title as best tertiary hockey club in the country.

 

Kovsies’ men’s team: Back, from the left are: Brad Hensberg, Rogan Jones, Mikhail Mannel, Egon van der Merwe, Stanley de Villiers,
Cheslyn Neethling, Michael Baiden, Richard Copley (physio) and Braam van Wyk (coach). Centre, from the left are: Darryl Sutherland,
Ian Finlay, Gerald van Blerk and Dylan Swanepoel (vice-capt). Front, from the left, are: Jaco Fourie, Qhayiya Jack, Berne Burger, Nazo
Mlakalaka, Kurt Hensberg, Lehan Bloemhoff and Ruan Kleinhans.

Kovsies’ women’s team: Back, from the left are: Madie Wessels, Izelle Lategan, Nisa van Zyl, Timon Botha, Jacques du Toit, Beatrix
Wesstdyk, Jacqie Ras, Jo Nelka Swanepoel and Lisa Hawker. Front, from the left are: Nicole Walraven, Tanya Britz, Line Malan (capt),
Minjon van Tonder (vice-capt), Kim Mentor, Inke Wolmarans and Cornelle Botha.

 

 

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