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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 academic appointed as team doctor for SA Olympic Team
2012-03-22

 

Dr Holtzhausen’s appointment reflects well on the quality of exercise and sports medicine presented at the university.
20 March 2012

Dr Louis Holtzhausen, Head of the university’s Department of Sports and Exercise Medicine, has been selected by the South African Sports Confederation and Olympic Committee (Sascoc) as team doctor for the more than 300 athletes that will represent South Africa at this year’s Olympic Games in London.

“This is definitely one of the most important highlights of my career, in which I’ve worked with professional athletes and top sporting people,” says Dr Holtzhausen, a recognised South African academic in Sports Medicine.

“It is not only an honour to be appointed as team doctor for the South African Olympic Team. It is also a privilege to represent the UFS. The fact that Sascoc approached me reflects well on the quality of exercise and sports medicine that we present here at the university,” says Dr Holtzhausen.

Dr Holtzhausen says he has already worked with some of the athletes in the Olympic Team. These include members of the South African boxing team, the hockey team, as well as track and field athletes that have been preparing for the Olympic Games at the university’s High Performance Unit.

There is, however, hard work ahead for Dr Holtzhausen. His work will start before the team leaves for London in July. “I have to ensure that all the athletes are healthy and that everyone’s immunisation programmes are up to date. We also have to ensure that no athlete takes banned substances,” he says.

During the Games, Dr Holtzhausen will keep an eye on the optimal functioning of every athlete. “Anything that could hamper them medically will be sorted – whether it’s a broken ankle or a cold,” he says.

He will also see to it that medical services are available during the competition. Immediate medical assistance will be available, especially at high contact sports like boxing.

Dr Holtzhausen has also been team doctor for Team South Africa at the All Africa Games, the biggest sporting event in Africa. He was recently appointed as a member of the International Committee and Coordinator for Africa of the worldwide Exercise is Medicine project. This project proposes that exercise be used in the prevention of chronic disease in the general population, as well as in the treatment of people with existing chronic diseases. Dr Holtzhausen is also an honorary member of the South African Sports Medicine Association (SASMA). This membership is awarded to members of the medical and scientific community who make significant contributions to the advancement of sports medicine.

Dr Holtzhausen is a member of the Vice-Chancellor’s Prestige Scholars Programme.
The goal with the Prestige Scholars Programme is to select no more than 100 of the most promising young scholars (typically holding lecturer status) and to make substantial investments in their development towards the professoriate. A tailored, intensive programme of support has been designed which combines international placement working alongside leading scholars in the discipline of the prestige scholar, with intensive mentorship and support from within the university.

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