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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

Another boost for sport at the UFS
2005-10-13

A contract formalizing the appointment of Sports Plan (Pty) Ltd was signed by Prof Verschoor and Mr Morne du Plessis in the historic Main Building of the UFS Bloemfontein campus.

 

The University of the Free State (UFS) has officially appointed Sports Plan (Pty) Ltd, which has former Springbok rugby captain Morné du Plessis as managing director, to manage its Centre for Exercise and Sport Science Services (CESSS) on the Bloemfontein campus.

According to Prof Teuns Verschoor, Vice-Rector: Academic Operations, the appointment of Sports Plan (Pty) Ltd is another step in the implementation of the UFS’s wide-ranging sport strategy to improve sport facilities and elevate formerly marginalized sports such as soccer, hockey, netball, tennis etc.

Sports Plan (Pty) Ltd is the manager of the Sports Science Institute of South Africa and coordinates and manages the national basketball high-performance programme of SA Basketball, as well as the Boxing Academy on behalf of Boxing South Africa. 

“It is also actively involved with the sports plans of several tertiary institutions like that of the University of Johannesburg and the University of Stellenbosch,” said Prof Verschoor.

“Sports Plan (Pty) Ltd was also appointed by the Ministry of Sport and Recreation to manage the allocation of sports codes to high-performance centres and to oversee the allocation of monies received from the National Lottery to these centres – this includes the CESSS at the UFS,” Prof Verschoor added.

In unfolding its national sports plan, the Ministry of Sport and Recreation has already identified the UFS-based CESSS as the high-performance testing centre for the national basketball teams whilst the national boxing teams are also earmarked to be trained at the UFS.

“We are glad to be associated with a company of this stature and look forward to work with them in the further development of sports at the UFS,” said Prof Verschoor.

According to Prof Verschoor, the CESSS will act as a centralised body that is responsible for the coordination and management of joint initiatives between professional service providers, research projects and KovsieSport.

“The centre will also coordinate and manage joint initiatives between various academic programmes in different academic subject fields such as sports medicine, bio kinetics, physiotherapy, dietetics, etc. ,” said Prof Verschoor.

These initiatives will help the UFS to become a centre and catalyst of sports development, to become internationally recognised in the field of exercise and sports science research and to become a centre for high quality sports performance enhancement.

Some of the objectives of the CESSS are:

  •  

  • To provide sports science services like to athletes, students, the general public and other stakeholders including certain national sport teams.
  • To provide the necessary teaching and training facilities and internship opportunities for UFS students in sports related fields of study will also be provided by the centre like human movement science.
  • To present skills-transfer programmes directed at the broader community like development of skills in various sporting codes.
  • To continue and extend the current chronic risk reversal programmes presented by the Department of Human Movement Science such as obesity management, cardiac rehabilitation and other lifestyle related conditions.

The centre was founded in 2003 and was until now managed by Dr Louis Holtzhausen, from Kovsie Health and a consultant, Dr Gary Vorster. 

A contract formalizing the appointment of Sports Plan (Pty) Ltd was signed today by Prof Verschoor and Mr Morne du Plessis in the historic Main Building of the UFS Bloemfontein campus.

 

 

 

 

The manager of the centre appointed by Sports Plan (Pty) Ltd is Mr Charles Store, an alumnus of the UFS, previously employed at the Sports Science Institute in Cape Town and by the SANDF at 3 Military Hospital, Bloemfontein.

 

Media release
Issued by: Anton Fisher
Director: Strategic Communication
072-207-8334
12 October 2005
 

 

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