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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 researchers receive awards from the NSTF
2008-06-04

The recipients of the two awards are, from the left: Prof. Jan van der Westhuizen, UFS Department of Chemistry, Dr Susan Bonnet, UFS Department of Chemistry, Prof. Thinus van der Merwe, FARMOVS-PAREXEL, Prof. Maryke Labuschagne, UFS Department of Plant Sciences, and Prof. Ken Swart, FARMOVS-PAREXEL.
Photo: Lacea Loader

  

UFS researchers receive awards from the NSTF   

The University of the Free State (UFS) last week received two prestigious awards from the National Science and Technology Forum (NSTF) during its tenth gala-awards ceremony held in Kempton Park.

Prof. Maryke Labuschagne from the Department of Plant Sciences at the UFS was the female recipient of the research capacity-development award over the last ten years. She received the award for her successful mentoring of black researchers and students. The award, sponsored by Eskom, includes a prize of R100 000 which will be used for research purposes.  

A team consisting of Prof. Jan van der Westhuizen and Dr Susan Bonnet from the Department of Chemistry at the UFS and Prof. Kenneth Swart and Prof. Thinus van der Merwe from FARMOVS–PAREXEL received the innovation award for an outstanding contribution to science, engineering and technology from either an individual or a team over the last ten years.
 
Prof. Labuschagne, an expert in the field of plant breeding and food security in Africa, received the award for her contribution to the training and development of black students and researchers in this field. Various black students successfully completed their postgraduate studies under her guidance at the UFS during the past ten years, with positive results.

Research by her South African students has led to a firmly entrenched research relationship between the Agricultural Research Council (ARC) and the UFS, while research by her local and international students has culminated in no less than 82 publications over the last decade.

It has also led to the establishment of collaboration agreements with universities and research institutes in Malawi, Kenya, Uganda and Tanzania – among others with the University of Malawi where Prof. Labuschagne and her students are involved in the International Programme in the Chemical Sciences (IPICS) of the Uppsala University in Sweden. The project focuses on the study of genetics and chemistry of tropical roots and tuber crops in Malawi. This has led to collaboration with international research organisations and has generated overseas funding.

The combined team from FARMOVS–PAREXEL and the UFS won an award for the synthesis of drug analogues used as reference products during the analysis of the drug concentration in blood, from existing and new drugs registered nationally and internationally.

The project resulted in capacity building in synthetic organic chemistry, mass spectrometry and chromatography: Five master’s degrees were completed, seven are in progress, and six postgraduate students commenced with Ph.D.’s.

The skills transferred during this project are already being applied to examine the properties of indigenous medicinal plants as part of the recently established UFS novel drugs and bioactive compound cluster.

Applied Biosystems, the Canadian manufacturer of mass spectrometers, donated equipment to the value of more than R10 million for this project. As a result the UFS is one of the few universities in the world that can offer postgraduate training in bioanalytical chemistry.

Prof. Hendrik Swart, head of the Department of Physics at the UFS, and Dr Martin Ntwaeaborwa, senior lecturer at the Department of Physics were finalist in the research- capacity developer and black-researcher categories respectively.
The NSTF awards gives recognition to the outstanding contributions of individuals and groups to science, engineering and technology. This includes all practising scientists, engineers and technologists across the system of innovation, including, for example, teachers and students in mathematics, science and technology. The NSTF represents government, science councils, professional bodies, higher education, business and civil society.

Altogether nine individuals and three organisations were presented with the NSTF Awards trophy by the Minister of Science and Technology, Mr Mosibudi Mangena.

Media Release
Issued by: Lacea Loader
Assistant Director: Media Liaison
Tel:  051 401 2584
Cell:  083 645 2454
E-mail:  loaderl.stg@ufs.ac.za
4 June 2008

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