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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

Names are not enough: a molecular-based information system is the answer
2016-06-03

Description: Department of Plant Sciences staff Tags: Department of Plant Sciences staff

Prof Wijnand Swart (left) from the Department of
Plant Sciences at the UFS and Prof Pedro Crous
from the Centraalbureau voor Schimmelcultures (CBS),
in the Netherlands.
Photo: Leonie Bolleurs

South Africa is the second-largest exporter of citrus in the world, producing 60% of all citrus grown in the Southern Hemisphere. It exports more than 70 % of its citrus crop to the European Union and USA. Not being able to manage fungal pathogens effectively can have a serious impact on the global trade in not only citrus but also other food and fibre crops, such as bananas, coffee, and cacao.

The Department of Plant Sciences at the University of the Free State (UFS) hosted a public lecture by Prof Pedro W. Crous entitled “Fungal Pathogens Impact Trade in Food and Fibre: The Need to Move Beyond Linnaeus” on the Bloemfontein Campus.

Prof Crous is Director of the world’s largest fungal Biological Resource Centre, the Centraalbureau voor Schimmelcultures (CBS), in the Netherlands. He is also one of the top mycologists in the world.

Since the topic of his lecture was very pertinent to food security and food safety worldwide, it was co-hosted by the Collaborative Consortium for Broadening the Food Base, a multi-institutional research programme managed by Prof Wijnand Swart in the Department of Plant Sciences.

Reconsider the manner in which pathogens are identified

Prof Crous stressed that, because international trade in products from agricultural crops will expand, the introduction of fungal pathogens to new regions will increase. “There is therefore an urgent need to reconsider the manner in which these pathogens are identified and treated,” he said.

According to Prof Crous, the older Linnaean system for naming living organisms cannot deal with future trade-related challenges involving pests and pathogens. A system, able to identify fungi based on their DNA and genetic coding, will equip scientists with the knowledge to know what they are dealing with, and whether it is a friendly or harmful fungus.

Description: The fungus, Botrytis cinerea Tags: The fungus, Botrytis cinerea

The fungus, Botrytis cinerea, cause of grey mould
disease in many fruit crops.
Photo: Prof Wijnand Swart

Embrace the molecular-based information system

Prof Crous said that, as a consequence, scientists must embrace new technologies, such as the molecular-based information system for fungi, in order to provide the required knowledge.

He presented this very exciting system which will govern the manner in which fungal pathogens linked to world trade are described. This system ensures that people from different countries will know with which pathogen they are dealing. Further, it will assist with the management of pathogens, ensuring that harmful pathogens do not spread from one country to another.

More about Prof Pedro Crous


Prof Crous is an Affiliated Professor at six international universities, including the UFS, where he is associated with the Department of Plant Sciences. He has initiated several major activities to facilitate global research on fungal biodiversity, and has published more than 600 scientific papers, many in high impact journals, and authored or edited more than 20 books.

 

 

Biography Prof Pedro Crous
Philosophical Transactions of the Royal Society B


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