Latest News Archive

Please select Category, Year, and then Month to display items
Years
2017 2018 2019 2020
Previous Archive
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

Prestigious awards, membership and two A-ratings from the NRF indicate a boom in research
2014-12-04

Several UFS researchers were honoured with awards this year. This includes, from the left: Prof Jeanet Conradie from the Department of Chemistry, Dr Aliza le Roux from the Department of Zoology and Entomology on the Qwaqwa Campus of the UFS, Profs Jonathan Jansen, Vice-Chancellor and Rector of the UFS.
Photo: Hannes Pieterse

The University of the Free State (UFS) had several highlights in the field of research this year. This includes two A-ratings, which were awarded by the National Research Foundation (NRF) to Prof Maxim Finkelstein from the Department of Mathematics and Actuarial Science, and Prof Melanie Walker, Senior Research Professor and Director of the Centre for Research on Higher Education and Development (CRHED) and DST/NRF Chair in Higher Education and Human Development.

Prof Finkelstein’s A2-rating makes him the only A-rated researcher in ‘Probability and Statistics’ regarding Mathematical Sciences in the country. Prof Walker was evaluated in the division for Research, Innovation Support and Advancement and received an A1-rating.

Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS, considers these ratings as one of the clearest signs that the standard for research across the institution has increased significantly.

Prof Jansen was honoured with the Academy of Science of South Africa’s (ASSAf’s) Science-for-Society Gold Medal for his outstanding achievement in scientific thinking to the benefit of society.

"An award such as this recognises the power of science and scholarship to improve the human condition," Prof Jansen said.

A further highlight at ASSAf’s prestigious annual awards ceremony was the induction of Prof Jeanet Conradie from the Department of Chemistry and Dr Aliza le Roux from the Department of Zoology and Entomology on the UFS’s Qwaqwa Campus as new members of ASSAf.

Prof Conradie was also this year’s first runner-up in the senior category for Distinguished Women Researchers: Physical and Engineering Science in the Department of Science and Technology’s 2014 Women in Science Awards.

Prof Corli Witthuhn: Vice-Rector: Research, describes Prof Conradie as a highly productive researcher who publishes in high-impact journals.

“Not only is she the first female professor in the Department of Chemistry, but she also has extensive international networks and collaboration which elevates the impact of her work even further,” Prof Witthuhn said.

Dr Le Roux is one of ten young researchers inaugurated as members of the South African Young Academy of Science (SAYAS). She was also elected to serve on the executive committee of SAYAS. According to Prof Witthuhn, Dr Le Roux is an outstanding young scientist.

“I am very excited about the young researchers on our Qwaqwa Campus, with Aliza as one of the leaders, and I am looking forward to what they will achieve in the next five years,” she said.

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept