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11 February 2021 Photo UFS photo archive
The National Control Laboratory for Biological Products (NCL) Building.

There can be no compromise when it comes to the quality of medicines made available to the public.

The UFS-based National Control Laboratory for Biological Products (NCL) is a full member of the international WHO-National Control Laboratory Network for Biologicals and one of 12 laboratories worldwide contracted to perform vaccine testing for the World Health Organisation (WHO). The NCL is also 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 the South African Health Products Regulatory Authority (SAHPRA).

In its role as a 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. 

International testing standards

The laboratory received the status of a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) endorsed its quality-management systems as of a high standard according to the International Standards Organisation’s requirements.

With its international testing standards, the NCL must ensure that all its operations – 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.

The laboratory has all the quality systems in place to ensure high-quality test results. The certificate of Good Manufacturing Compliance received in 2019 indicates that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. This certification is very strict and means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world. The certification offers the South African Health Products Regulatory Authority, the WHO, and other national control laboratories around the world the confidence that the test results from the NCL can be trusted.

Licensed as pharmaceutical manufacturer

The laboratory is also licensed as a pharmaceutical manufacturer. Although the lab does not manufacture, it needs 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.

News Archive

Prof Finkelstein current and only A-rated researcher in Probability and Statistics in SA
2014-10-28



Prof Maxim Finkelstein
Photo: Johan Roux
Prof Maxim Finkelstein from the Department of Mathematical Statistics at the University of the Free State (UFS) received an A-rating from the National Research Foundation (NRF). This makes him the only A-rated researcher in ‘Probability and Statistics’ regarding Mathematical Sciences in the country.

According to the NRF-rating process, a person with an A-rating is a world leader in his field. 

Prof Jonathan Jansen, Vice-Chancellor and Rector, said: "I am absolutely delighted for Professor Finkelstein and for the fact that this is one of the clearest signs that the UFS has significantly increased its standards of research across the institution as a whole."

Prof Finkelstein says this rating means a great deal to him, since it is a reflection of his dedication and perseverance.

“Of course, the rating is not a goal in itself,” Prof Finkelstein says. “The goal is the high quality research and the rating is just an objective indication of this. Along with the satisfaction, this rating brings the responsibility for maintaining this high status in the future.”

Prof Finkelstein conducts his general research in the field of ‘Probability and Statistics’, but his specific area of focus is ‘Stochastic Modelling’. Prof Finkelstein solely lectures postgraduate students and also mentors a few master’s and PhD students. This affords him the time to mainly concentrate on his research.

“Finally, I wish to emphasise the fact that high-quality research became the prime goal at the UFS,” says Prof Finkelstein. He underscores the efforts of the Vice-Chancellor and the Vice-Rector: Research in creating excellent possibilities for researchers. This has already resulted in remarkable improvements in the UFS’s research outputs – and consequently an increase in the number of rated researchers at the university.

A total of 119 UFS researchers currently have evaluation and rating status from the NRF, says Nico Benson, Deputy Director: Research Development. Currently (October 2014) 29 researchers are still waiting for response from the NRF regarding applications submitted. A total of 16 ratings are already known. On the Qwaqwa Campus of the UFS, five researchers are rated.

Prof Finkelstein's A-rating will become effective from 1 January 2015. Ratings are valid for a period of six years and researchers are invited to apply for re-evaluation in the fifth year.


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