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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 celebrates research excellence
2016-02-25

Description: UFS celebrates research excellence Tags: UFS celebrates research excellence

Researchers at the university were acknowledged for their new research ratings. From the left are: Prof Johann de Wet, Department of Communication Sciences; Prof Naomi Morgan, Department of Afrikaans and Dutch, German and French; Prof Corli Witthuhn, Vice-Rector: Research; Prof André Pelser, Department of Sociology; Dr Trudi O’Neill, Department of Microbial, Biochemical and Food Biotechnology; and Prof Riaz Seedat, Department Otorhinolaryngology.

During a recent gala occasion, the University of the Free State (UFS) acknowledged 15 of its researchers who received new ratings from the National Research Foundation (NRF).

According to Prof Corli Witthuhn, Vice-Rector: Research at the UFS, 37 applications have already been received for the next round of ratings by the NRF. In recent years, the university has experienced an increase in the rating of its researchers as the result of raised academic standards. These are in line with the Academic Project of the UFS. The UFS has 125 rated researchers in total.

The 15 recipients of new ratings from the NRF in 2015,are:

- Dr Tanya Beelders, Computer Science: Y2
- Dr Andrew Cohen, History: Y1
- Prof Pieter de Villiers, Theology: C2
- Prof Johann de Wet, Communication: C3
- Dr Angelinus Franke, Agriculture: C2
- Prof Jonathan Jansen, Education: B1
- Prof Riaan Luyt, Chemistry: B3
- Prof Naomi Morgan, Linguistics: C2
- Dr Trudi O’Neill, Microbiology: C1
- Prof André Pelser, Sociology: C3
- Dr Johann Rossouw, Philosophy: C2
- Prof Riaz Seedat, Health: C3
- Dr Jakub Urbaniak, Theology: Y2
- Dr Martin van Zyl, Mathematics: C3
- Prof Sue Walker, Soil, Crop and Climate Sciences: C1

The UFS also celebrated its five SARChI research chairs during this event. The main goal of the research chairs is to promote research excellence.

The five research chairs at the UFS are all established at Tier 1. Research chairs in the Tier 1 category are based on the researcher's research track record, as well as on the training record of his/her postgraduate and postdoctoral students.  Tier 1 research chairs are awarded to established researchers who are leaders in their field, and whose work is recognised internationally.

The following research chairs have been awarded to the UFS since 2013:

- Solid State Luminescent and Advanced Materials, Prof Hendrik Swart in the Department of Physics (2013-2017)
- Disease Resistance and Quality in Field Crops, Prof Maryke Labuschagne (2016-2020)
- Higher Education and Human Development, Prof Melanie Walker (2013-2017)
- Vector-Borne and Zoonotic Pathogens, Prof Felicity Burt (2016-2020)
- Humanities without Borders: Trauma, History and Memory (2016-2020) 

 

 

 

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