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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 appoints Director: KovsieRugby
2012-10-16

Michael Horak.
Photo: Johan Roux
16 October 2012

Mr Michael Horak has been appointed for a three year term by the UFS as Director: KovsieRugby. He began working at the university on 1 October 2012.

Mr Horak’s involvement in and experience of Super Rugby coaching, his working relationship with the Free State Rugby Union, his understanding of coaching structures and systems, as well as his knowledge of Kovsie players and present structures made him the obvious choice. He is also well positioned to see to it that the Shimlas are prepared for the next Varsity Cup tournament, which begins in February 2013.

His career includes the position of General Manager of the Cheetahs and Rugby Affairs at the Free State Rugby Union, a defence coach in Super Rugby, as well as senior Currie Cup teams and a rugby consultant for Grey College and Windhoek Gymnasium.

Some of his responsibilities as Director of KovsieRugby include the coaching of the Shimlas (head coach); the planning, development, management and implementation of a coordinated coaching and rugby programme throughout all sections of the UFS Rugby club; the development and implementation of innovative coaching techniques and methods in regards to players; as well as the development and implementation of a medium and long term strategy for the recruitment and retention of players that will be approved by the university to make success possible.

On his vision for rugby at the UFS, Mr Horak says: “It is a great privilege for me to be involved with KovsieRugby. Good work was done by Mr Jaco Swanepoel that I would like to take further to give players the best chance to be successful. Winning is what it is about and I am really looking forward to the challenges that lie ahead for all of us. My coaching team of Quintin Kruger, Hendro Scholtz and Barry Goodes is incredibly motivated to serve Shimlas rugby and to achieve success. We hope that everybody will support us and we are looking forward to seeing everybody at Shimla Park when the Shimlas win!”

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