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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

Geology researcher wins international photographic contest
2017-06-02

Description: Dr Elizaveta Kovaleva Tags: Dr Elizaveta Kovaleva

In this winning photo, “Movement of the ancient sand”,
Dr Matthew Huber, postdoctoral research fellow in the
Department of Geology at UFS, is scaling an outcrop
of sandstone (former sand dunes) in the Zion National
Park in the US.
Photo: Dr Elizaveta Kovaleva


Dr Elizaveta Kovaleva and Dr Matthew Huber, postdoctoral research fellows in the Department of Geology at the University of the Free State (UFS), attended the European Geosciences Union (EGU) General Assembly in Vienna, Austria in April 2017, where Dr Kovaleva was declared a winner of the EGU photo contest with a photograph entitled “Movement of the ancient sand”.

Submitting the winning photo
Each participant could submit up to three photos to participate in the contest before the conference. From all the photographs 10 were selected and displayed for the entire week at the assembly so participants could vote for their three favourite photos. At the end of the week three winners were selected. The prize winners received a free EGU book of their choice, free registration for next year’s EGU and an option to judge the photo competition next year. The photos will be printed on postcards next year, so all participants can send them wherever they want around the globe.

“The picture was taken in the Zion National Park in the US. Myself and Dr Huber were travelling around the western states, visiting national parks. The person in the picture is Dr Huber,” said Dr Kovaleva.

Dr Kovaleva was also invited to participate - as a recently published author - in a workshop, called: ”Publishing in EGU journals: Solid Earth and Earth Surface Dynamics – Meet the Editors”.

At the assembly, Dr Kovaleva attended sessions on Tectonics and Structural Geology as well as on Geochemistry, Mineralogy, Petrology and Volcanology. These sessions were especially interesting in the scope of her research and are directly related to it. “I am a metamorphic petrologist, and with my PhD, I essentially studied microstructures. At the moment, I am studying the Vredefort impact crater, which has experienced both metamorphism and deformation,” she said.

“The winning photos will be printed on postcards,
so all participants can send them wherever they
want around the globe”.

Building scientific connections
For both researchers, the assembly was an opportunity to meet former colleagues and professors from universities all over the world and shake hands with authors whose papers and work they were familiar with, but had never met in person.

“EGU is a perfect opportunity to build scientific connections and relationships, advertise your research and start new collaborations and projects,” said Dr Kovaleva.

The EGU General Assembly 2017 was a great success, with 4 849 oral, 11 312 poster, and 1 238 PICO presentations. Some 649 unique scientific sessions, together with 88 short courses and 322 side events, created an interesting programme. At the conference 14 496 scientists from 107 countries participated, of whom 53% were under the age of 35. Thirty one were from South Africa.

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