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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

Researcher in Plant Breeding one of nine women on the African continent to receive acknowledgement for work in food security
2015-08-04

 
 Prof Maryke Labuschagne

Prof Maryke Labuschagne, Plant Breeding researcher in the Department of Plant Sciences at the University of the Free State (UFS), is one of only nine women on the African continent to receive the prestigious ‘Country Lifetime Achiever Award’ from Africa’s Most Influential Women in Business and Government Programme (MIW) this year.

During a breakfast event, CEO Communications recognised the Most Influential Women in SADC South who are Building Nations. The event took place at the Vodacom Dome in Midrand on 28 July 2015.

She received the award for her commitment and continuous contributions to food security. “I am concerned about this. We need to develop people who can go into Africa to work together for food security on the continent,” says Prof Labuschagne.

Prof Labuschagne
and her students’ research focuses on the genetic improvement of food security crops in Africa, including such staples as maize and cassava. “These crops are genetically improved for yield, drought tolerance, disease, and insect resistance, as well nutritional value.”

“Food security is one of the key factors for stability and prosperity on the continent,” she says.

Apart from the fact that her research is helping to provide food for thousands of people on the continent, she is also an NRF-rated researcher, and author or co-author of over 160 articles in accredited journals.

This is not the firstaward that Prof Labuschagne has received for her work. In 2008, she was chosen as the National Agriculturalist of the Year by the Agricultural Writers Association of South Africa. In 2012, she received the Researcher of the Year award from Grain South Africa, as well as the African Union’s Kwame Nkrumah Science Award for Life Sciences on the continent. 

The Country Lifetime Achiever Award is a prestigious award that recognises and honours the lifelong efforts, achievements, and contributions by individuals in their local communities. This recognition covers all sectors and countries, to create a platform where the work and involvement of extraordinary people can be displayed and noted.

About the award, Prof Labuschagne says: “It is always great to be recognised for your work.”

Elana Meyer (athlete) and Thuli Madonsela (Public Protector and advocate) have also received awards from the programme this year.

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