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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 receives R13,7 Million for Research into Prehistoric Organisms
2007-03-27

Some of the guests attending the launch of the research contract are: Dr Siyabulela Ntutela (Deputy Director: Biotechnology at the Department of Science and Technology), Dr Godfrey Netswera (Manager of Thuthuka and the Support Programme at the National Research Foundation (NRF)), Dr Esta van Heerden (Platform Manager and lecturer at the Department of Microbial, Biochemical and Food Biotechnology at the UFS), Mr Butana Mboniswa (Chief Executive Officer of BioPAD), and Mr Vuyisele Phehani (Portfolio Manager for BioPAD).
Photo: Leonie Bolleurs

The University of the Free State (UFS) has been awarded a massive R13,7 million contract to conduct research into prehistoric micro-organisms which live under extreme conditions, for example in mineshafts.

This is one of the biggest research contracts awarded to the UFS in recent years.

The biotechnology research contract was awarded to the UFS by BioPAD, a South African biotechnology company that brokers partnerships between researchers, entrepreneurs, business, government and other stakeholders to promote innovation and create sustainable biotechnology businesses.

The project is endorsed by the Department of Science and Technology and the National Research Foundation (NRF), which contributes to the bursaries of the 17 postgraduate students on the programme.

The contract involves the establishment of a Platform for Metagenomics -  a technique which allows researchers to extract the DNA from microbes in their natural environment and investigate it in a laboratory. 

“Through this platform we will be able to understand deepmine microbial populations
and their potential application in the search for life in outer space.  It is most likely
that, if life were to be found on other planets in our solar system, it would probably
resemble that which existed millions of years ago on earth.  Apart from all this, these
organisms have unique properties one can exploit in biotechnological application for
South Africa and its community,” said Dr Esta van Heerden, platform manager and
lecturer at the UFS Department of Microbial, Biochemical and Food Biotechnology.
She is assisted by her collegues, Prof. Derek Litthauer and Dr Lizelle Piater.

“The platform aims to tap into the unique genetic material in South African mines
which will lead to the discovery of new genes and their products.  These new and unique products will find application in the medical field (anti-cancer, anti-bacterial en anti-viral cures), the industrial sector (nanotechnology, commercial washing agents and the food industry), environmental sector (pollution management, demolition of harmful metals and other toxic waste),” said Dr Van Heerden.

According to Dr Van Heerden, the Metagenomics Platforms stems from the Life in
Extreme Environments (LExEN) programme which was started in 1994 by Princeton
University in the United States of America (USA) in South African mines with grants
from among others the National Aeronautics and Space Administration (NASA) and
the National Science Foundation (NSF) in the USA.  Other international collaborators
on the project include Geosynec Consultants Inc. (USA), Oak Ridge National
Laboratory (USA), the University of Tennessee (USA) and in South Africa the
Universities of the Witwatersrand, North West and Limpopo and companies like BHP
Billiton, MINTEK and mining companies like Harmony, Gold Fields and AngloGold
Ashanti.

The research field laboratory of the Metagenomics Platform, which was situated in
Glen Harvey, was moved to the Main Campus of the UFS in Bloemfontein.  “In this
way the university has become the central hub for all research programmes.  We are
also the liaison between the LExEN programme and the various mining companies
involved,” said Dr Van Heerden.  The new laboratory was introduced during the
launch of the research contract.

“Our decision to commit BioPAD to this project stems from the company’s commitment to advance human capacity development to strengthen South Africa’s research infrastructure.  It is also part of our aim to create and protect intellectual property,” said Mr Butana Mboniswa, Chief Executive Officer of BioPAD.

Talking on behalf of the UFS senior management, Prof. Teuns Verschoor, Vice-Rector
of Academic Operations, said that the university shares the excitement to be part of
the exploration of unknown forms of life, the discovery of new genes and
their products and in applying newly gained knowledge to better understand our
universe.

Media release
Issued by: Lacea Loader
Assistant Director: Media Liaison 
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl@ufs.ac.za
27 March 2007

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